Confidential Treatment Requested Under
17 C.F.R. (S)(S)200.80 (b)(4) and 230.406
PATENT LICENSE AGREEMENT
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1. Parties. This license agreement is made and entered into on this 1st day
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of December 1999 and is by and between Xxxxxx-Xxxx Pharmaceuticals,
Incorporated, a Delaware corporation (hereafter "Xxxxxx-Xxxx"), having a
principal place of business at 0000 Xxxxxxx Xxxxxx, Xxxxx 000, Xxx Xxxxx, XX
00000, and Xx. Xxxxx X. Xxxxx (hereafter "Licensor'), having a residence at 0000
Xxxxx Xxxx, Xxxxxxxx, Xxxxxxxx 00000 (collectively, the "Parties"). The Parties
agree to the terms and conditions set forth hereinbelow ("Agreement"). This
Agreement shall be effective as of the last date signed below.
2. Definitions. The following definitions apply to the capitalized words
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whenever they are used in this Agreement. Capitalized words that are not defined
in this section have the meanings given to such words where they are otherwise
defined in this Agreement.
2.1 "Affiliate" means any company or entity controlled by, controlling, or
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under common control with Xxxxxx-Xxxx and shall include any company fifty
percent (50%) or more of whose voting stock or participating profit interest is
owned or controlled, directly or indirectly, by Xxxxxx Xxxx, and any company
which owns or controls, directly or indirectly, fifty percent (50%) or more of
the voting stock of Xxxxxx-Xxxx.
2.2 "Combination Product" means a Licensed Product sold in combination with
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at least one other therapeutically active substance.
2.3 "Control(s)" or "Controlled" means possession of the ability to grant a
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license or sublicense as provided for herein without violating the terms of any
agreement or other arrangement with any third party.
2.4 "Improvements" means [...***...].
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2.5 "Know-How" means, to the extent useful for the discovery, development,
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manufacture, use or sale of Licensed Products or the use or practice of the
Licensed Patents or Improvements, all tangible know-how, trade secrets,
inventions (whether or not patentable), data, preclinical and clinical results,
physical, chemical or biological material, and other information that (a)
Licensor Controls on the effective date of this Agreement or (b) is
independently developed by Licensor during the term of this Agreement, and, in
each case, any replication or any part of such information or material.
2.6 "Licensed Patents" means, collectively, those U.S. Patents and Patent
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Applications and foreign patents and patentapplications, including all
divisions,
*CONFIDENTIAL TREATMENT REQUESTED
continuations and continuations-in-part of such patent applications which
Licensor exclusively or jointly owns and which are listed below under the groups
designated A, B, C or D:
Group Patent No. Country Licensor's Ownership Status
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[...***...]
Patent Applications:
Group Publication No. Country Assignor's Ownership
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Status
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[...***...]
2. *CONFIDENTIAL TREATMENT REQUESTED
2.7 "Licensed Process" means any method or process that is within the scope
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of one or more claims of the Licensed Patents.
2.8 "Licensed Product" means a pharmaceutical product the manufacture, use
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or sale of which is covered by a Valid Claim within the Licensed Patents or
within any patent or patent application claiming any Improvement.
2.9 "Net Sales" means the following:
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(a) For any Licensed Product that has received Regulatory Approval, the
amount [...***...] or, in the event of the transfer of any Licensed Product
(other than as a sale) to one or more third parties (other than bona fide
samples provided for testing, development, marketing, demonstration, or similar
purposes), the [...***...];
(b) For any Combination Product that has received Regulatory Approval, the
[...***...] or, in the event of transfer of any Combination Product (other than
as a sale), to one or more third parties (other than bona fide samples provided
for testing, develop-ment, marketing, demonstration, or similar purposes), the
[...***...]; provided, however, that in no event shall such formula result in
royalties due under Section 4.2 hereof of less than the greater of [...***...]
percent ([...***...]%) of the net sales of the entire Combination Product or the
royalty which would otherwise have been due on account of the sale of the amount
of Licensed Product contained in the Combination Product.
(c) The following are not included in the term "Net Sales:"
1. [...***...];
2. [...***...]; and/or
3. *CONFIDENTIAL TREATMENT REQUESTED
3. [...***...].
In calculating "Net Sales," any Licensed Product unit or Licensed Process
unit that is sold shall be taken into account only once, even if more than one
valid claims in one or more of the Licensed Patents claims the Licensed Product
or Licensed Process.
2.10 "Regulatory Approval" shall mean any approval (including, without
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limitation, price and reimbursement approvals), licenses, registrations or
authorizations of any federal, state or local regulatory agency, department,
bureau or other government entity, necessary for the manufacture, use, storage,
import, transport or sale of a pharmaceutical product in a regulatory
jurisdiction.
2.10 "Sublicensee" means any person, firm, corporation, partnership or
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limited liability company to which Xxxxxx-Xxxx or any of its Affiliates elect to
grant the right to use any of the Licensed Patents (defined below) subject to
this Agreement.
2.11 "Sublicense Royalties" means royalties actually received by
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Xxxxxx-Xxxx or its Affiliates from any Sublicensee arising solely from the sale
of Licensed Products by Sublicensees.
2.12 "Valid Claim" means either (a) a claim of an issued and unexpired
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patent included within the Licensed Patents or within the Improvements which has
not been held permanently revoked, 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, and which has not been admitted
to be invalid or unenforceable through reissue or disclaimer or otherwise or (b)
a claim of a pending patent application included within the Licensed Patents or
within the Improvements, which claim was filed in good faith and has not been
abandoned or finally disallowed without the possibility of appeal or refiling of
said application.
3. Grant. Licensor hereby grants to Xxxxxx-Xxxx, subject to the terms and
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conditions hereof, an exclusive (even as to Licensor) worldwide license under
the Licensed Patents, Licensed Processes, Know-How and Improvements to discover,
develop, make, use, have made, sell, have sold and import Licensed Products (the
"Grant") [***]. In addition, Xxxxxx-Xxxx shall have the unrestricted right to
sublicense any of the rights granted hereunder to any Sublicensee; provided,
however, Xxxxxx-Xxxx shall promptly notify Licensor in writing of the identity
of such Sublicensee and shall provide Licensor with a true and complete copy of
any agreement(s) with any such Sublicensee(s). Xxxxxx-Xxxx shall further have
the right to extend this license to any of its Affiliate(s) provided it promptly
notifies Licensor
4. *CONFIDENTIAL TREATMENT REQUESTED
in writing of the identity and relationship of any such Affiliate(s) and
provides Licensor with a true and complete copy of any written agreement(s)
pertaining thereto. This Grant includes a grant of all of Licensor's rights in
the Licensed Patents, including any abandoned or pending division, continuation,
continuation-in-part, renewal, reissue, reexamination, extension, substitute
application, inventor certificate, certificate of addition or certificate of
correction that is based on, or derived from, any of the subject matter
disclosed in any of the Licensed Patents anywhere worldwide. The Grant does not
include an assignment of ownership to Xxxxxx-Xxxx. The Xxxxx is subject to the
reservation by Licensor of the right to make and have made and to use Licensed
Products in Licensor's laboratories for pre-clinical research purposes only, but
not for any commercial purpose. Any right that the United States of America may
have under any Licensed Patent shall remain in effect and shall not be affected
by any provision of this Agreement.
4. Compensation. Xxxxxx-Xxxx shall compensate Licensor for the Grant as
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follows:
4.1 License Fees. Upon execution of this Agreement, Xxxxxx-Xxxx will pay a
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non-refundable license fee of $[...***...], receipt of which is hereby
acknowledged by Licensor. In addition, Xxxxxx-Xxxx shall pay Licensor the annual
license fees set forth below for each group of Licensed Patents on each
anniversary _date of this Agreement commencing in the year 2000. The annual
license fees to be paid to Xxxxxx-Xxxx to Licensor pursuant to this Agreement
are as follows:
$ [...***...] for Group A Licensed Patents
$ [...***...] for Group B Licensed Patents
$ [...***...] for Group C Licensed Patents
$ [...***...] for Group D Licensed Patents
With respect to the annual licensing fee for Group C Licensed Patents, the
annual license fee shall increase to $[***] per year when and if Xxxxxx-Xxxx
decides to enter into Phase I clinical trials with respect to all or any part of
the Licensed Patents within Group C.
[...***...]
5. *CONFIDENTIAL TREATMENT REQUESTED
Xxxxxx-Xxxx'x obligation to pay the foregoing license fees shall continue
until (1) there is no longer a Valid Claim or (ii) Xxxxxx-Xxxx terminates this
Agreement as set forth in the next sentence and in Section 5.2 hereof. If
Xxxxxx-Xxxx exercises its right hereunder to terminate this Agreement with
respect to all, or any group, of Licensed Patents, its obligation to pay the
License Fees for that (those) group(s) of Licensed Patents shall cease and
Licensor shall thereafter be free to license such patents to others. If
Xxxxxx-Xxxx terminates this Agreement as to one or more groups of Licensed
Patents during any year, it shall not be entitled to a refund of that year's
license fees applicable to the terminated group from Licensor. All fees paid by
Xxxxxx-Xxxx to Licensor pursuant to this Section 4.1 in any given year shall be
creditable in full against earned royalties that become payable to Licensor
pursuant to Sections 4.2 and 4.3 for such year, and any such credit taken shall
be noted in the applicable report submitted to Licensor pursuant to Section 4.5.
4.2 Royalty Payments to Licensor. In addition to the foregoing annual
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License Fees, subject to Sections 4.1, 4.3 and 4.4, Xxxxxx-Xxxx shall pay to
Licensor, commencing with calendar year 2000, a semi-annual royalty of
[...***...]% of Net Sales for the preceding six month period for Net Sales
related to the Licensed Patents in Group A and [...***...]% of Net Sales for the
preceding six month period for Net Sales related to the Licensed Patents in
Groups B, C, and X. Xxxxxx-Xxxx'x obligation to pay such royalties shall
continue while this Agreement is in effect. Royalty payments are due to Licensor
within 30 days after the end of the preceding semi-annual period. Except as
provided in Section 2.9(c)(3), hereof, any tax or other assessment on any
payment due Licensor under this Section in any country in which such payment
accrued shall be paid by Xxxxxx-Xxxx without deduction from the amount owed to
Licensor. Xxxxxx-Xxxx shall keep accurate records of all Licensed Products made,
used, sold or otherwise disposed of under this Agreement to determine the amount
of royalty due for each specific period.
4.3 Sublicense Royalties. Subject to Sections 4.1, Xxxxxx-Xxxx shall pay to
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Licensor an amount equal to [...***...] percent ([...***...]%) of Sublicense
Royalties with respect to Net Sales derived from the Licensed Patents in Group
A, and an amount equal to [...***...] percent ([...***...]%) of Sublicense
Royalties with respect to Net Sales derived from the Licensed Patents in Groups
B, C and D. Such royalties shall be due at the time and in the manner as
specified in Section 4.2, above.
4.4 Third Party Royalties. If Xxxxxx-Xxxx enters into third party licenses
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in order for it to practice the License granted hereunder, Xxxxxx-Xxxx'x
obligation to pay royalties to Licensor with respect to those sales shall be
reduced to an amount equal to [...***...] percent ([...***...]%) of the Net
Sales of Licensed Products and Licensed Processes with respect to the Licensed
Patents in Group A and to amount equal to [...***...] percent ([...***...]%) of
Net Sales of Licensed Products and Licensed Processes with respect to the
Licensed
6. *CONFIDENTIAL TREATMENT REQUESTED
Patents in Groups B, C and D. Such royalties shall be due at the time and in the
manner as specified in Section 4.2, above.
4.5 Royalty Reports. Xxxxxx-Xxxx shall provide Licensor, within sixty (60)
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days after each calendar half-year ending June 30 and December 31 st, a true and
complete report, signed by an appropriate corporate officer with knowledge and
authority, setting forth the amount of Licensed Products and Licensed Processes
made, used, sold, or otherwise disposed of by Xxxxxx-Xxxx, its Affiliates and
Sublicensees. Payment of the royalty shall accompany each such report. If no
royalty is due to Licensor for any report period, the written report shall so
indicate.
4.6 Patent maintenance and prosecution costs. Licensor agrees to and shall
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continue prosecution and maintenance of the Licensed Patents. To this end,
Licensor shall permit Xxxxxx-Xxxx to have access to (and upon request copies of)
any' files related to any Licensed Patents at the U.S. Patent and Trademark
Office or in any foreign patent office including, without limitation, the
European Patent Office. Such access (or copies if requested) shall be granted to
one or more attorneys selected by Xxxxxx-Xxxx; provided, however, Licensor shall
have the right to hire counsel of his own choice to prosecute and maintain the
Licensed Patents. Licensor shall instruct his counsel to cooperate and consult
with Xxxxxx-Xxxx'x patent counsel with regard to responding to office actions or
taking any other discretionary actions related thereto. Nothing herein shall be
construed to give Xxxxxx-Xxxx veto authority over Licensor's patent prosecution
decisions but such decisions shall be made in a lawful and commercially
reasonable manner. Xxxxxx-Xxxx will pay patent maintenance and prosecution fees
or costs for the Licensed Patents in countries of commercial interest, beginning
with a payment of up to $5,000.00 for any fees or costs that are due and unpaid,
or which have accrued and are unpaid as of the effective date of this Agreement.
During the term of the Agreement, Xxxxxx-Xxxx agrees to reimburse Licensor's
documented costs for obtaining and maintaining rights in any Licensed Patent(s)
including, but not limited to, filing fees, maintenance fees, prosecution
expense, appeals to a patent office, reissue, term-extension, reexamination,
interference, opposition and nullity proceedings, including costs that may arise
on account of an action by Xxxxxx-Xxxx, its Affiliate(s) and/or Sublicensees,
but not including infringement. If litigation or other unusual legal expenses
are incurred in defense of such rights, Licensor agrees to choose suitable
counsel to defend or prosecute such case(s) and shall do so in consultation with
Xxxxxx-Xxxx. Licensor shall provide copies of invoices or other documentation to
support his prosecution, maintenance and legal costs in advance of any payment.
Such payments shall be paid to Licensor within 30 days of Xxxxxx-Xxxx'x receipt
of invoices or other documentation that support these costs. If Xxxxxx-Xxxx
elects not to support prosecution or maintenance of a Licensed Patent in a given
country, Licensor may do so at Licensor's expense. This Agreement shall be
terminable by Licensor with respect to such Licensed Patent in such country.
Licensor agrees to notify Xxxxxx-Xxxx in writing in a timely manner that it does
not desire to support the continued prosecution or appeals or maintenance of any
patent
7.
applications or patents included in the Licensed Patents. Licensor agrees to
file, prosecute or maintain any patent application or patent included in the
Licensed Patents in any country requested by Xxxxxx-Xxxx. In the event Licensor
declines to pursue, or does not, within thirty (i0) days following written
request from Xxxxxx-Xxxx, take requested action with respect to, the filing,
prosecution or maintenance of any patent applications or patents included in the
Licensed Patents in any given country, Xxxxxx-Xxxx may, at its own expense,
continue to prosecute or maintain such application or patent in such country.
4.7 Ownership of Inventions. Ownership of inventions conceived using any
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Licensed Patents, Licensed Processes, Improvements or Know-How shall be
determined in accordance with United States patent laws. Xxxxxx-Xxxx shall have
the sole and exclusive right, but not the obligation, to file, prosecute and
maintain all patent applications and patents relating to Improvements to the
Licensed Patents.
4.8 Research Reports. Xxxxxx-Xxxx shall provide Licensor with semi-annual
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reports detailing its activities and efforts to develop Licensed Products and/or
Licensed Processes by using some, or all, of the Licensed Patents. Xxxxxx-Xxxx'x
reports shall include a description of research and development with respect to
any products or processes, or both, in relation to any claims in the Licensed
Patents and shall further detail any scientific, research or marketing problems
that may have been encountered in relation thereto. Such information shall be
Confidential Information under this Agreement.
4.9 Commitment to Preclinical Product or Process Development. From time to
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time the Parties shall jointly confer in good faith for the purpose of
identifying and evaluating Licensed Products or Licensed Processes within the
scope of one or more claims of Licensed Patents for development. The evaluation
will include a review of any associated Know-How owned by Licensor, including
Licensor's raw data or other information related to the Licensed Patents known
to Licensor at the time of the evaluation. Based on this evaluation, Xxxxxx-Xxxx
will select one or more candidate compound(s) and human therapeutic
application(s) for preclinical development provided such are within the scope of
one or more claims in the Licensed Patents. Xxxxxx-Xxxx will pay for all
pre-clinical research or development work reasonably needed under the law and
applicable regulations enacted by relevant regulatory agenc(ies) to prepare a
proper regulatory filing for submission to the regulatory agenc(ies) for
initiation of a phase I or a phase I/II clinical trial. The decision to file the
investigative new drug approval ("IND") and to conduct the clinical trial rests
exclusively with Xxxxxx-Xxxx, but Xxxxxx-Xxxx will make the decision on whether
to proceed with a clinical trial in good faith and after full consultation with
Licensor. If Xxxxxx-Xxxx decides not to proceed with a clinical trial,
Xxxxxx-Xxxx will fully inform Licensor of its reasons. In funding this
preclinical development, Xxxxxx-Xxxx will keep Licensor informed about the
progress of the development and give Licensor a full opportunity to comment on,
and participate in
8.
the design of, any experimental work. Licensor shall, with reasonable notice,
and on a periodic basis, have the right to inspect all data generated by, or
related to, the preclinical development and clinical work. Xxxxxx-Xxxx'x
obligation to continue to fund this preclinical product or process development
continues until, and unless, this Agreement is terminated as set forth
hereinbelow or Xxxxxx-Xxxx determines in good faith that the commercial market
for the Licensed Product or Licensed Process has diminished such that continued
development is not commercially advisable or until the preclinical development
is completed, whichever occurs earlier. Xxxxxx-Xxxx shall oven all information,
data and other intellectual property arising from all development projects
pursuant to this Agreement, all of which is Confidential Information.
5. Term and Termination. This Agreement shall expire when the last of the
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Licensed Patents expires unless terminated earlier as provided for below.
5.1 The following events will trigger Licensor's right to terminate this
Agreement: (1) Xxxxxx-Xxxx sells or transfers all, or substantially all, of its
assets for the benefit of its creditors; (2) Xxxxxx-Xxxx materially breaches any
of its obligations in this Agreement; and fails to cure such breach with the
following time-frame: (A) If said breach relates to non-payment of licensing
fees or royalties to Licensor, the cure time shall be 30 days following written
notice of such breach; (B) If said breach relates to any other claimed breach
unrelated to failure to pay licensing fees or royalties then Xxxxxx--Eden shall
have 60 days following written notice of such breach to cure said breach, unless
Xxxxxx-Xxxx, in good faith, reasonably commences the cure of said breach within
such 60-day period and pursues the cure of such breach in good faith but in no
event shall such breach remain for more than 120 days. If Xxxxxx-Xxxx fails to
cure any such breach within the relevant time, then Licensor shall have the
right to terminate this Agreement, in which event Xxxxxx-Xxxx shall have no
further rights whatsoever in, or related to, any Licensed Patents, but shall
nevertheless be liable for and pay to Licensor, all amounts then due under this
Agreement. If Licensor elects to terminate this Agreement under this Section
5.1, then Xxxxxx-Xxxx shall have the right to complete all contracts for the
sale of Licensed Products or Licensed Processes that Xxxxxx-Xxxx is obligated to
sell as of the termination date on which net sales Xxxxxx-Xxxx shall owe and pay
Licensor those royalties set out in Section 4.2 above.
5.2 Xxxxxx-Xxxx shall have the right, upon giving Licensee 60 days advance
written notice, to sever any of the groups of Licensed Patents from this
Agreement. If Xxxxxx-Xxxx elects to relinquish any such rights, it understands
and agrees that it shall forego, give up, and relinquish any and all rights it
has acquired by virtue of this Agreement related to such Licensed Patents and
shall cooperate with Licensor in transferring any such Licensed Patents to
Licensor, free and clear of all claims whatsoever. Upon severing of one of more
groups of Licensed Patents, Licensor shall have the right to sell, assign or
license the severed patents or any combination of them, and may otherwise
practice the inventions described therein. Xxxxxx-Xxxx shall not be
9.
entitled to any refund for licensing fees paid in respect to any relinquished
groups of Licensed Patents.
5.3 The right of either Party to terminate under the provisions of this
Section is not an exclusive remedy, and either Party is entitled to damages for
breach of this Agreement, to equitable remedies such as an order requiring
performance of the obligations of this Agreement. or to any other legal or
equitable remedies. Xxxxxx-Xxxx may terminate this Agreement, and Xxxxxx-Xxxx'x
obligations for each group of Licensed Patents, independently.
6. Licensor's Representations and Warranties. Licensor represents and
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warrants to Xxxxxx-Xxxx as follows: (A) That he has the right to license the
Licensed Patents in the manner provided for herein; (B) That no license or
covenant not to xxx under any Licensed Patent is in effect for any third party;
(C) That, to the best of Licensor's knowledge or belief, the Licensed Patents do
not infringe on, or misappropriate, any copyright, patent right, trade secret or
other proprietary rights (collectively "Proprietary Rights") of any third party;
(D) There are no pending or threatened suits by any third party based on any
alleged violation of any third party's Proprietary Rights; (E) That Licensor is
not aware of any claims, or the existence of any facts that might reasonably be
the basis of any claims, that the Licensed Patents or this Agreement violates
any third party's Proprietary Rights; and (F) That Licensor will not grant any
right or interest in any Licensed Patent to any other person or entity as long
as Xxxxxx-Xxxx maintains this License for the Licensed Patent. [***].
7. Third Party Infringement. During the term of this Agreement, Licensor
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shall promptly report to Xxxxxx-Xxxx information that Licensor has regarding any
known or suspected infringement by any third party of any claim in the Licensed
Patents. Licensor will promptly provide all information and evidence available
to support the known or suspected infringement. As long as Xxxxxx-Xxxx maintains
this license for any
10. *CONFIDENTIAL TREATMENT REQUESTED
of the Licensed Patents, Xxxxxx-Xxxx has, in its sole discretion, the exclusive
right to initiate and prosecute any suit for infringement of the Licensed
Patents or other appropriate suit in its own name and on its own behalf anywhere
worldwide against such a third party, at Xxxxxx-Xxxx'x expense. In lieu of
filing a lawsuit for any known or suspected infringement, Xxxxxx-Xxxx may elect
to negotiate with the known or suspected infringer for a settlement. Xxxxxx-Xxxx
will keep Licensor apprised of the progress of any such suit or negotiation.
Xxxxxx-Xxxx will not settle any such suit or negotiation without Licensor's
written consent, which shall not be unreasonably withheld. If Xxxxxx-Xxxx elects
not to initiate or maintain a lawsuit or settlement negotiation, Xxxxxx-Xxxx
will promptly notify Licensor of its decision, and Licensor may then elect to
initiate or prosecute the suit at Licensor's expense. Licensor will not settle
any such suit or negotiation without Xxxxxx-Xxxx'x written consent, which shall
not be unreasonably withheld. Each Party will cooperate in good faith as
reasonably needed with the initiation or prosecution of any suit or negotiation.
The amount of any proceeds or damages recovered from such a suit or negotiation
exceeding the Parties' expenses, shall be allocated to the Parties in proportion
to their economic interest after payment of expenses. Xxxxxx-Xxxx may settle any
claim, suit or negotiation, including by granting the infringing party a
sublicense under the terms of this Agreement.
8. Confidentiality.
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8.1 Confidential Information. Except to the extent expressly authorized by
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this Agreement or otherwise agreed in writing by the parties, the parties agree
that, during the term of this Agreement and for five (5) years thereafter, the
receiving party shall keep confidential and shall not publish or otherwise
disclose and shall not use for any purpose other than as expressly provided for
in this Agreement any Confidential Information furnished to it by the other
party pursuant to this Agreement. Each party may use such Confidential
Information only to the extent required to accomplish the purposes of this
Agreement. Each party will use at least the same standard of care as it uses to
protect proprietary or confidential information of its own to ensure that its
employees, agents, consultants and other representatives do not disclose or make
any unauthorized use of the Confidential Information. Each party will promptly
notify the other upon discovery of any unauthorized use or disclosure of the
Confidential Information. For purposes of this Agreement, "Confidential
Information" means all information, inventions, know-how or data disclosed by a
party to the other pursuant to this Agreement, including, without limitation,
manufacturing, marketing, financial, personnel, scientific and other business
information and plans, and the material terms of this Agreement, whether in
oral, written, graphic or electronic form.
8.2 Exceptions. Confidential Information shall not include any information
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which the receiving party can prove by competent evidence:
11.
(a) is now, or hereafter becomes, through no act or failure to act on the
part of the receiving party, generally known or available;
(b) is known by the receiving party at the time of receiving such
information, as evidenced by its records;
(c) is hereafter furnished to the receiving party by a third party, as a
matter of right and without restriction on disclosure; or
(d) is the subject of a written permission to disclose provided by the
disclosing party.
8.3 Terms of Agreement. The parties agree that this Agreement and the terms
------------------
hereof will be considered Confidential Information of both parties.
Notwithstanding the foregoing, either party may disclose such terms as are
required to be disclosed under strictures of confidentiality to bona fide
potential sublicensees or as otherwise required pursuant to applicable law.
8.4 Authorized Disclosure.
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(a) Each party may disclose Confidential Information belonging to the
other party to the extent such disclosure is reasonably necessary in the
following instances:
(i) filing or prosecuting patents or patent applications within the
Licensed Patents;
(ii) regulatory filings;
(iii) prosecuting or defending litigation;
(iv) complying with applicable court orders or governmental
regulations;
(v) conducting preclinical or clinical trials of Licensed Products;
and
(vi) disclosure to Affiliates, sublicensees, employees, consultants,
agents or other third parties in connection with due diligence or similar
investigations by such third parties, in each case who agree to be bound by
similar terms of confidentiality and non-use at least equivalent in scope to
those set forth in this Article 8.
Notwithstanding the foregoing, in the event a party is required to make a
disclosure of the other party's Confidential Information pursuant to this
Section 8.4, it will, except where impracticable, give reasonable advance notice
to the other party of such disclosure and use efforts to secure confidential
treatment of such information at least as diligent as such
12.
party would use to protect its own confidential information, but in no event
less than reasonable efforts. In any event, the parties agree to take all
reasonable action to avoid disclosure of Confidential Information hereunder. The
parties will consult with each other on the provisions of this Agreement to be
redacted in any filings made by the parties with the Securities and Exchange
Commission or other similar authority in an applicable jurisdiction or as
otherwise required by law.
(b) Notwithstanding any other provision of this Agreement, Xxxxxx-Xxxx
shall have the absolute right to publish any know-how, trade secrets, inventions
(whether or not patentable), data, preclinical and clinical results, physical,
chemical or biological material, and other information generated, made,
conceived or reduced to practice by its employees and agents through the use or
practice of the Licensed Patents, the Licensed Processes, the Improvements or
the Know-How.
9. Miscellaneous.
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9.1 Licensor's Right to Inspect Records. During this Agreement and for two
-----------------------------------
years thereafter, Xxxxxx-Xxxx will keep records showing the sales of
royalty-bearing and relevant related transactions in sufficient detail to enable
Licensor to determine the royalties payable under this Agreement. During the
term of this Agreement, and for one year thereafter, Licensor has the right; at
Licensor's expense, to have a public accounting firm selected by him, but
subject to Xxxxxx-Xxxx'x approval, which shall not unreasonably be withheld,
examine the relevant books and records of account of Xxxxxx-Xxxx (and the books
of the appropriate Affiliate, or Sublicensee) once per calendar year pertinent
to the sale of any Product or Process subject to the royalty provisions of
Section 4.2 or 4.3. The inspection is solely to determine whether appropriate
accounting and payments were made. Licensor will provide at least 5 working days
advance notice for any inspection hereunder, which will be during normal
business hours. These inspection rights are limited to inspection of the records
that relate to the four most recently concluded semi-annual periods that
generated royalties, but no semi-annual period is subject to inspection more
than once. The accounting firm will disclose to Licensor only whether the
records are correct or not and the specific details concerning any
discrepancies. No other information will be shared. If such inspection
determines that Xxxxxx-Xxxxx has underreported and underpaid royalties due under
Sections 4.2, 4.3 and/or 4.4 by more than five percent (5%), the entire cost of
such inspection shall be borne by Xxxxxx-Xxxx. Any information that Licensor or
the public accounting firm obtains or receives under this Section is
Confidential Information.
9.2 Licensor's Obligation To Keep Xxxxxx-Xxxx Informed. During the term of
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this Agreement, Licensor may generate preclinical data or information related to
the Licensed Patents or that utilizes one or more of the compounds recited in
one or more claims in the Licensed Patents ("License-Related Information"). To
keep Xxxxxx-Xxxx'x clinical development effort fully appraised of all
potentially relevant information,
13.
Licensor will provide Xxxxxx-Xxxx with copies of, or access to, all
License-Related Information within 90 days of its generation, unless Licensor's
work is incomplete or in process, in which event the disclosures shall be made
no later than 90 days after the completion of such work. Licensor shall give
Xxxxxx-Xxxx at least 30 days advance notice of any public disclosure or
submission for publication of any License-Related Information. Licensor must
take Xxxxxx-Xxxx'x comments, if any, into account when Licensor makes a public
disclosure of License-Related Information. In the event that, in the interest of
protecting its intellectual property, Xxxxxx-Xxxx objects to the public
disclosure by Licensor of any License-Related Information, such public
disclosure shall be postponed, at the sole discretion of Xxxxxx-Xxxx, for a
period not to exceed 90 days.
9.3 Registration. Where this Agreement's terms require or make it
------------
appropriate that the Agreement or any part of it be registered with, or reported
to, a national or supranational agency having authority, Xxxxxx-Xxxx will,
within 120 days of the effective date of this Agreement, and at Xxxxxx-Xxxx'x
expense, initiate such registration or report. Xxxxxx-Xxxx will keep Licensor
informed of the registration or reporting.
9.4 Notices. Any notice under this Agreement must be in writing and is
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effective when either delivered in person, sent by Federal Express, DHL, Express
Mail or by facsimile transmission, or deposited as registered or certified U.S.
mail, postage prepaid, addressed to the Party at the address in Section 1 or at
such other address as either party may request in writing. Either Party may, by
notice to the other Party designate a different address.
9.5 Governing Law; Jurisdiction. This Agreement shall be governed by, and
---------------------------
construed under, the laws of the State of California. The Parties hereby submit
and consent to the jurisdiction of the federal courts in the State of California
or the Commonwealth Virginia (at the option of the suing party). If a federal
forum is unavailable in one or both of such states, then the state courts in the
State of California or the Commonwealth of Virginia may be resorted to by either
party with respect to any action, dispute, proceeding or claim arising out of or
under this Agreement, provided, however, nothing herein will restrict the
parties from resorting to the courts of any jurisdiction in order to collect,
enforce or execute any judgment obtained in the federal or state courts in any
other state with jurisdiction over the party against whom the judgment was
rendered.
9.6 Assignment. Neither Party may assign or transfer this Agreement, or any
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rights or obligations under this Agreement, without the prior written consent of
the other Party; provided however, that Xxxxxx-Xxxx may, without Licensor's
consent, assign its rights and obligations under this Agreement to any
Affiliate, but must first give Licensor written notice of such assignment;
provided further, that Xxxxxx-Xxxx may, without Licensor's consent but with
advance written notice to Licensor, assign this Agreement to any successor by
merger or sale of substantially all of its business or assets to which this
14.
Agreement relates. The terms of this Agreement shall be binding on, and inure to
the benefit of, the heirs and executors of Licensor and to the authorized
assigns and successors of Xxxxxx-Xxxx, whether by merger, consolidation,
transfer of all or substantially all assets, or otherwise.
9.7 Indemnification by Xxxxxx-Xxxx. Xxxxxx-Xxxx hereby agrees to indemnify
------------------------------
and hold Licensor entirely harmless from, and against, any and all liabilities,
demands, damages, expenses, or losses, arising out of Xxxxxx-Xxxx'x, any of its
Affiliate's or any of its Sublicensee's exercise of any right under any Licensed
Patent under this Agreement. Such indemnification shall include payment of
Licensor's reasonable attorney's fees and litigation expenses if Licensor is
called upon to defend against any such claims, liabilities, or demands or to pay
any such damages, expenses or losses.
9.8 Indemnification by Licensor. Licensor hereby agrees to indemnify and
---------------------------
hold Xxxxxx-Xxxx harmless from, and against, all liabilities, demands, damages,
expenses, or losses under this Agreement that arise from any (i) false,
fraudulent, or misleading representations made to Xxxxxx-Xxxx in this Agreement
or (ii) grossly negligent or intentional act or omission by the Licensor which
xxxxx Xxxxxx-Eden. Such indemnification shall include payment of Xxxxxx-Xxxx'x
reasonable attorney's fees and litigation expenses if Xxxxxx-Xxxx is called upon
to defend against any such claims, liabilities, or demands or to pay any such
damages, expenses or losses.
9.9 Severability. The Parties agree that each provision herein is a
------------
separate and independent clause, and the unenforceability of any one clause in
no way impairs the enforceability of any of the other clauses. If a final
judgment of the highest competent authority holds that one or more of the
provisions of this Agreement is unenforceable, the Parties intend modification
of such provision so as to be enforceable to the maximum extent that is
compatible with applicable law and consistent with the intent expressed in this
Agreement.
9.10 Equitable Relief. Licensor agrees that any breach of this Agreement by
----------------
him will cause irreparable damage to Xxxxxx-Xxxx and, in the event of such a
breach, Xxxxxx-Xxxx has, in addition to any and all remedies of law, the right
to an injunction, specific performance, or other equitable relief to prevent the
violation of Licensor's obligations hereunder. Xxxxxx-Xxxx agrees that any
breach of this Agreement by Xxxxxx-Xxxx will cause irreparable damage to
Licensor and, in the event of such breach Licensor shall have, in addition to
any and all remedies of law, the right to an injunction, specific performance or
other equitable relief to prevent the violation of Xxxxxx-Xxxx'x obligations
hereunder.
9.11 Entire Agreement; Amendments. This Agreement contains the entire
----------------------------
agreement of the Parties with respect to the matters covered, and no other
previous agreement, statement or promise made by either Party not contained in
the terms of this
15.
Agreement are binding or valid. The Parties may amend this Agreement only by a
writing that both Parties sign.
IN WITNESS WHEREOF, the parties have set their hands hereto, the
corporate party acting by and through a duly authorized officer on this 1st day
of December 1999.
XXXXXX-XXXX PHARMACEUTICALS, INC.
(Licensee)
Date: 12-3-99 By: /s/ Xxxxxxx X. Xxxxxx
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ITS: Chairman and CEO
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XX. XXXXX X. XXXXX
(Licensor)
Date: Dec. 01, 1999 By: /s/ Xx. Xxxxx X. Xxxxx
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16.
