Portions of this exhibit marked [*] are requested to be treated confidentially. LICENSE AGREEMENT
Exhibit
10.1
Portions
of this exhibit marked [*] are requested to be treated
confidentially.
This
License Agreement, effective upon the date of last signature herein (the
"Effective Date"), by and between The Penn State Research Foundation
(hereinafter referred to as "PSRF"), a non-profit corporation duly organized
and
existing under the laws of the Commonwealth of Pennsylvania and having an office
at 000 Xxx Xxxx, Xxxxxxxxxx Xxxx, XX 00000, and INNOVIVE Pharmaceuticals, Inc.
a
corporation organized under the laws of the State of Delaware (hereinafter
referred to as "LICENSEE"), having its principal office at 000 Xxxxxxx Xxxxxx,
00xx Xxxxx, Xxx Xxxx, Xxx Xxxx 00000.
WITNESSETH
WHEREAS,
Xx. Xxx X. Xxxxx, Xx. Xxxxxxxx X. XxXxxxxxxx and Xx. Xxxx X. Xxxxx, employees
of
The Pennsylvania State University (the "UNIVERSITY") have made inventions
entitled: "Opioid Growth Factor and Cancer", filed as The Pennsylvania State
University Invention Disclosure No. 96-1565, "Combination Therapy with Opioid
Growth Factor and Taxanes for the Treatment of Cancer", filed as The
Pennsylvania State University Invention Disclosure No. 2003-2839, and "Combined
Therapy with Opioid Growth Factor and Gemcitabine for the Treatment of Cancer",
filed as The Pennsylvania State University Invention Disclosure No. 2004-2890,
(the "INVENTIONS");
WHEREAS,
PSRF is dedicated to fostering and advancing scientific research within the
Commonwealth of Pennsylvania and, in particular, within the UNIVERSITY and
is
responsible for developing inventions made by employees of the UNIVERSITY by
evaluating invention disclosures, pursuing patents, and pursuing licensing
arrangements thereon;
WHEREAS,
PSRF is the owner of certain "PATENT RIGHTS" (as defined herein below) relating
to the INVENTIONS and has the right to grant licenses under PATENT
RIGHTS;
WHEREAS,
LICENSEE has represented to PSRF, to induce PSRF to enter into this Agreement,
that it shall commit itself to a thorough, vigorous and diligent program of
exploiting the PATENT RIGHTS so that public utilization shall result therefrom;
NOW
THEREFORE, in consideration of the mutual promises and covenants set forth
herein and for good and valuable consideration, the adequacy and sufficiency
of
which is hereby acknowledged, the parties hereby agree as follows:
ARTICLE
1 - DEFINITIONS
For
purposes of this License Agreement, the following words and phrases shall have
the following meanings:
1.1
"IMPROVEMENTS"
shall mean any modification of a LICENSED PROCESS or LICENSED PRODUCT or any
INVENTIONS (whether patentable or not), information and data, in the FIELD
OF
USE that, developed by Drs. Zagon, XxXxxxxxxx and Xxxxx and those acting under
their control and direction, for a period of [*] years from the Effective Date,
the manufacture use or sale of which would infringe an issued or pending claim
within the PATENT RIGHTS.
[*]
Confidential treatment requested; certain
information omitted and filed separately with the SEC.
1
1.2
"KNOW-HOW"
shall mean all currently existing tangible information
within the FIELD OF USE (other than those contained in the PATENT RIGHTS)
whether patentable or not (but which have not been patented) and physical
objects related to the INVENTIONS or to the LICENSED PRODUCTS, including but
not
limited to formulations, biological samples, tissues, animals, organisms,
compounds, intermediates, laboratory notebooks, in vitro, preclinical or
clinical design, information or results, other proprietary materials, processes,
including but not limited to manufacturing processes, data, drawings and
sketches, designs, testing and test results, regulatory information of a like
nature, owned by any of PSRF, which PSRF have the right to disclose and license
to the LICENSEE, provided however, that the provision hereunder shall be subject
to the reasonable time and clinical constraints of Xx. Xxx X. Xxxxx, Xx.
Xxxxxxxx X. XxXxxxxxxx and Xx. Xxxx X. Xxxxx.
1.3
“LICENSED
PROCESS(ES)” shall mean any process, use or method, which is covered, in whole,
or in part, by at least one unexpired VALID CLAIM of PATENT RIGHTS in the
country in which the process or method is used.
1.4
"LICENSED
PRODUCT(S)" shall mean any product or part thereof, or use of a product or
part
thereof, which is covered in whole or in part by at least one unexpired VALID
CLAIM of PATENT RIGHTS in the country in which any such product or part thereof
is made, used, or sold.
1.5
"FIELD
OF
USE" shall mean all human uses in the field of oncology and the treatment of
neoplasia, including tumors (whether cancerous or not).
1.6
"PATENT
RIGHTS" shall mean all of the following without limitation:
a)
The
United States patents and patent applications listed in Appendix B and any
additions thereto that shall be added by amendment during the term of this
license; divisionals, continuations, and continuations in part (to the extent
the practice of licensed subject matter would infringe any claims) wherein
the
claimed invention arises from subject matter specifically described in the
specification of the aforesaid patent applications, and the resulting patents,
and any patents resulting from reissues, renewals, extensions, substitutions,
additions, continuations, continuations in part, or reexaminations of the United
States patents described above;
b)
The
foreign patents and foreign patent applications listed in Appendix B, and any
additions thereto that shall be added by amendment during the term of this
license, divisionals, and continuations, continuations in part (to the extent
the practice of licensed subject matter would infringe any claims), wherein
the
claimed invention arises from subject matter specifically described in the
aforesaid foreign patent applications, or arises from subject matter described
in any U.S. applications and patents listed in Appendix B, and any foreign
patents resulting from equivalent foreign procedures to United States reissues
and reexaminations of the foreign patents described above;
2
c)
Any
United States and/or foreign patents issuing from any of the
foregoing.
1.7
"NET
SALES" shall mean the total gross receipts for the sale, lease, transfer or
consignment to independent third parties of a LICENSED PRODUCT or LICENSED
PROCESS by or on behalf of the LICENSEE or any of its AFFILIATES or
sublicensees, whether invoiced or not, less only the sum of the following:
(a)
usual trade discounts to customers; (b) sales, tariff duties and/or use taxes
directly imposed and with reference to particular sales; (c) outbound
transportation prepaid or allowed and transportation insurance; (d) packaging
and freight charges; (e) bad debt deductions (not to exceed [*]% of NET SALES),
actually written off during the accounting period; and (f) amounts allowed
or
credited on returns, each determined in accordance with generally accepted
accounting principles consistently applied. It is understood that the intent
of
both parties is that PSRF shall receive its royalty on the basis of the market
price for sale of LICENSED PROCESSES or LICENSED PRODUCTS to clinicians or
end
users.
|
1.8
|
"TERRITORY"
shall mean the World.
|
| 1.9 | "VALID CLAIM" shall mean any claim of any unexpired patent included among the PATENT RIGHTS, which has not been held unenforceable, unpatentable or invalid by a decision of a court or governmental body of competent jurisdiction, unappealable or unappealed within the time allowed for appeal, which has not been rendered unenforceable through disclaimer or otherwise or which has not been lost through an interference proceeding. |
| 1.10 | “AFFILIATE(S)” shall mean with respect to any Entity, any Entity that directly or indirectly controls, is controlled by, or is under common control with such Entity. Control for purposes of this definition shall mean control (by ownership, contract or otherwise) of at least fifty percent (50%) of the voting equity of the respective organization. Such AFFILIATES shall be bound by the relevant terms and conditions of this Agreement. |
[*] Confidential treatment requested; certain information
omitted and filed separately with the SEC.
3
| 1.11 | “INDICATION” shall mean the use of LICENSED PRODUCTS or LICENSED PROCESSES in the treatment of abnormal cell proliferation, including tumors (whether cancerous or not), cancer, or other neoplasias, such as pancreatic, colon, and head and neck cancer, wherein said indications are unique in that LICENSEE will be required to conduct clinical trials with specific end points relating to such use or treatment for the FDA or other applicable regulatory agency to approve such use of a LICENSED PRODUCT OR LICENSED PROCESS for such indication. |
| 1.12 | “INITIATE A PHASE I CLINICAL TRIAL” shall mean the date a patient is first dosed with a LICENSED PRODUCT, in the first Phase I clinical trial sponsored by the LICENSEE or its sublicensee or AFFILIATE. |
| 1.13 | “INITIATE A PHASE II CLINICAL TRIAL” shall mean the date a patient is first dosed with a LICENSED PRODUCT, in the first Phase II clinical trial sponsored by the LICENSEE or its sublicensee or AFFILIATE. |
| 1.14 | “INITIATE A PHASE III CLINICAL TRIAL” shall mean the date a patient is first dosed with a LICENSED PRODUCT, in the first Phase III clinical trial sponsored by the LICENSEE or its sublicensee or AFFILIATE. |
| 1.15 | “NON SALES RELATED INCOME” means all amounts, and all consideration, including equity, received by LICENSEE or AFFILIATE from their sublicensees in consideration of any sublicense or other similar agreement, including but not limited to initial license fees, clinical milestone payments, license maintenance payments, and all other payments or other consideration made to LICENSEE or AFFILIATE for such grant other than (a) payments received from the sale of debt or equity securities of LICENSEE or AFFILIATE and (b) payments directly relating to the sale of one or more LICENSED PRODUCTS or LICENSED PROCESSES, including royalties. |
ARTICLE
2 - THE LICENSE
2.1
Subject
to any preexisting rights of the Government of the United States created by
the
use of Government funding, PSRF hereby grants to LICENSEE and the LICENSEE
hereby accepts an exclusive right and exclusive license in the FIELD OF USE
under the PATENT RIGHTS, KNOW-HOW, and IMPROVEMENTS (such licensing of
IMPROVEMENTS subject to any restrictions imposed by any government agency or
not-for-profit organization) in the TERRITORY (a) to make, have made, use,
lease
and/or sell the LICENSED PRODUCTS and to practice and have practiced the
LICENSED PROCESSES, to the full end of the term for which the PATENT RIGHTS
are
granted, unless sooner terminated as hereinafter provided and (b) to sublicense
to third parties, in accordance with the terms of this Agreement.
2.2
PSRF
reserves the rights for itself and the UNIVERSITY to practice under the PATENT
RIGHTS for its own research and educational purposes.
2.3
LICENSEE
acknowledges that PATENT RIGHTS resulted from federally-supported research,
and
their assignment is governed by the applicable provisions of the Federal funding
agreements, including the 35 USC Chapter 18 (the “Xxxx-Xxxx Act”), 37 CFR Part
401.
4
2.4
LICENSEE
shall have the exclusive right, at its sole discretion, to sublicense any of
the
rights, privileges and licenses granted hereunder during the term of this
License Agreement. All sublicenses granted by LICENSEE or AFFILIATE or
sublicensee of their rights hereunder shall be subject to the terms of this
License Agreement and shall provide for the payment of running royalties
hereunder at amounts at least equal to the levels specified for payments by
LICENSEE to PSRF in Paragraph 3.2 hereof. Sublicensees shall not be permitted
to
grant any further sublicenses without prior written notification to PSRF.
LICENSEE shall be responsible for its sublicensees and shall not grant any
rights which are inconsistent with the rights granted to and obligations of
LICENSEE hereunder. Any act or omission of a sublicensee which would be a breach
of this License Agreement if performed by LICENSEE shall be deemed to be a
breach by LICENSEE of this License Agreement. Upon termination of this Agreement
other than by expiration in accordance with Article 14, any and all sublicenses
shall survive such termination, provided such sublicensee accepts, in writing,
the obligations of LICENSEE in Articles 3 and 4. Notwithstanding the foregoing,
if LICENSEE believes that the PSRF has terminated this Agreement for the primary
purpose of doing business directly with the sublicensee, the termination may
be
disputed under the provisions of Article 13 and this Agreement shall remain
in
full force and effect while such dispute is resolved.
2.5
Each
sublicense agreement granted by LICENSEE shall include an audit right by PSRF
of
the same scope as provided in Article 5 hereof with respect to LICENSEE.
2.6
LICENSEE
agrees to forward a copy of any and all sublicense agreements, including
sublicenses issued by sublicensees, to PSRF promptly after execution thereof,
and to forward to PSRF a copy of reports received by LICENSEE from its
sublicensees under the sublicenses as shall be pertinent to a royalty accounting
under said sublicense agreements.
2.7
The
license rights granted hereunder shall not be construed to confer any rights
upon LICENSEE by implication, estoppel or otherwise to any technology owned
or
controlled by PSRF which is not specifically set forth herein.
2.8
PSRF
also
grants to LICENSEE the right of a first option to negotiate a royalty-bearing
license to intellectual property derived or filed subsequent to the Effective
Date that is directly related to the exogenous administration of
[Met5]-enkephalin
and that is created by Xx. Xxx X. Xxxxx, Xx. Xxxxxxxx X. XxXxxxxxxx and Xx.
Xxxx
X. Xxxxx, which is outside of the FIELD OF USE, for a period of [*] years from
the Effective Date. LICENSEE shall advise PSRF as to its decision to negotiate
a
license within [*] days of notice from PSRF of said intellectual
property.
2.9
LICENSEE
shall not receive from sublicensees anything of value in
lieu
of cash
payments in consideration for any sublicense under this License Agreement,
without prior written notification to PSRF.
[*]
Confidential treatment requested; certain
information omitted and filed separately with the SEC.
5
ARTICLE
3 - PAYMENTS
3.1
In
partial consideration of the rights granted by this License Agreement, LICENSEE
shall
pay
to PSRF a non-refundable,
License
Issue Fee of [*] Dollars ($[*]) within thirty (30) days of the execution of
this
License Agreement.
3.2
During
the term of the License Agreement, LICENSEE shall pay to PSRF royalties equal
(i) to [*] percent ([*]%) of NET SALES of LICENSED PRODUCTS or LICENSED
PROCESSES by LICENSEE and/or AFFILIATES of up to [*] Dollars ($[*]) in any
calendar year, [*] percent ([*]%) of NET SALES in excess of [*] Dollars ($[*])]
but less than [*] Dollars ($[*]) in any calendar year, and [*] percent ([*]%)
of
NET SALES equal to or in excess of [*] Dollars ($[*]) in any calendar year;
or
(ii) if LICENSEE or AFFILIATE or sublicensee has entered into a sublicense
agreement with a third party, LICENSEE or AFFILIATE shall pay to PSRF: (a)
royalties in an amount equal to [*] Percent ([*]%) of the royalties received
by
the LICENSEE or AFFILIATE from any sublicensee, provide however, that in no
event shall the royalty paid by LICENSEE or AFFILIATE to PSRF be less than
[*]%
of NET SALES by any sublicensee; and (b) [*].
3.3
The
LICENSEE or AFFILIATE shall make the following one-time milestone payments
to
PSRF:
(a)
[*]
Dollars [*] upon the first dosing of a patient, with a LICENSED
PRODUCT, in the first Phase II clinical trial sponsored by the LICENSEE or
its
sublicensee or AFFILIATE under a LICENSEE or sublicensee or AFFILIATE sponsored
Investigative New Drug application (“an IND”);
(b)
[*]
Dollars ($[*]) upon the first dosing of a patient, with a LICENSED PRODUCT,
in
the first Phase III clinical trial sponsored by the LICENSEE or its sublicensee
or AFFILIATE;
(c)
[*]
Dollars ($[*]) upon the acceptance for review of the first LICENSEE or
sublicensee or AFFILIATE sponsored New Drug Application (an “NDA”) by the Food
and Drug Administration (“FDA”) for a LICENSED PRODUCT;
(d)
[*]
Dollars ($[*]) upon the final approval by the FDA of the first LICENSEE or
sublicensee or AFFILIATE sponsored NDA for a LICENSED PRODUCT filed by the
LICENSEE or its sublicensee or AFFILIATE;
(e)
[*]
Dollars ($[*]) upon the final approval by the FDA of the first LICENSEE or
sublicensee or AFFILIATE sponsored NDA for a LICENSED PRODUCT filed by the
LICENSEE or its sublicensee or AFFILIATE for an INDICATION other than that
approved by the FDA in (d) above;
(f)
[*]
Dollars ($[*]) upon the final approval by the FDA of the first LICENSEE or
sublicensee or AFFILIATE sponsored NDA for a LICENSED PRODUCT filed by the
LICENSEE or its sublicensee or AFFILIATE for an INDICATION other than that
approved by the FDA in (d) and (e) above;
[*]
Confidential treatment requested; certain
information omitted and filed separately with the SEC.
6
(g)
[*]
Dollars ($[*]) upon the acceptance for review of the first LICENSEE or
sublicensee or AFFILIATE sponsored NDA (or such similar document) by the
European Medicines Association (the “EMA”) for the commercial sale of a LICENSED
PRODUCT;
(h)
[*]
Dollars ($[*]) upon the final approval by the EMA of the first LICENSEE or
sublicensee or AFFILIATE sponsored NDA (or such similar application) for the
commercial sale of a LICENSED PRODUCT filed by the LICENSEE or its sublicensee
or AFFILIATE in the European Union;
(i)
[*]
Dollars ($[*]) upon the acceptance for review of the first LICENSEE or
sublicensee or AFFILIATE sponsored NDA (or such similar document) by the
applicable Japanese regulatory authorities for the commercial sale of a LICENSED
PRODUCT;
(j)
[*]
Dollars ($[*]) upon the final approval by the applicable Japanese regulatory
authorities of the first LICENSEE or sublicensee or AFFILIATE sponsored NDA
(or
such similar application) for the commercial sale of a LICENSED PRODUCT filed
by
the LICENSEE or its sublicensee or AFFILIATE in Japan;
3.4
Payment
of the royalties specified in Article 3.2 shall be made by LICENSEE to PSRF
within ninety (90) days after June 30 and December 31 of each year during the
term of this License Agreement covering the quantity of LICENSED PRODUCTS or
LICENSED PROCESSES sold by LICENSEE during the preceding half year. After
termination or expiration of this License Agreement, a final payment shall
be
made by LICENSEE covering the whole or applicable partial half-year. Each
royalty payment shall be accompanied by a written statement of NET SALES as
described in Article 5.2 hereunder.
3.5
LICENSEE
shall promptly report the achievement of each milestone specified in Article
3.3. The milestone payments specified in Article 3.3 shall be made by LICENSEE
to PSRF within thirty (30) days after the completion of said milestone.
3.6
All
payments due hereunder are expressed in and shall be paid by check payable
in
United States of America currency, without deduction of exchange, collection
or
other charges, to PSRF in University Park, PA or at such other place as PSRF
may
reasonably designate.
3.7
For
converting into United States dollars any payment accrued hereunder in the
currency of any other country, the rate of exchange for the purchase of United
States dollars with such currency quoted by The Chase Manhattan Bank, New York,
New York, on the last business day of the payment period in question shall
be
used.
3.8
No
multiple royalties shall be payable because any LICENSED PRODUCTS, their
manufacture, use, lease or sale are or shall be covered by more than one patent
application, patent or certificate of registration licensed under this License
Agreement. In addition, royalties shall be paid for a LICENSED PRODUCT or
LICENSED PROCESS based upon only one of Articles 3.2(i) or 3.2(ii) above (that
is, royalties on direct sales of a LICENSED PRODUCT or LICENSED PROCESS by
the
LICENSEE or its AFFILIATES shall be based only on Article 3.2(i), while
royalties on sales of a LICENSED PRODUCT or LICENSED PROCESS by any sublicensee
shall be based solely on Article 3.2(ii), so as to avoid double
counting).
[*]
Confidential treatment requested; certain
information omitted and filed separately with the SEC.
7
3.9
All
payments set forth in this Agreement shall, if overdue, bear interest until
payment at a per annum rate of [*]% above the prime rate in effect at the Chase
Manhattan Bank, New York, New York, on the due date. The payment of such
interest shall not foreclose PSRF from exercising any other rights it may have
as a consequence of the lateness of any payment.
3.10
In
the
event that a LICENSED PRODUCT is sold in the form of a combination product
containing one or more products or technologies which are themselves not
included in the PATENT RIGHTS, the NET SALES for such combination product shall
be calculated by equitably determining through mutual agreement the value added
to the combination product by the LICENSED PRODUCT.
ARTICLE
4 - DUE DILIGENCE AND MARKETING EFFORTS
4.1
(a)
LICENSEE
or AFFILIATE shall use all reasonable commercial efforts to bring LICENSED
PRODUCTS and/or LICENSED PROCESSES to market through thorough, vigorous and
diligent programs for exploitation of the PATENT RIGHTS and to achieve the
milestones set forth in Article 3.3 as timely and efficiently as possible.
(b)
LICENSEE
or AFFILIATE shall be required to satisfy the following diligence
milestones:
(i)
Within
[*] months of the Effective Date, LICENSEE or sublicensee or AFFILIATE shall
INITIATE A PHASE I CLINICAL TRIAL (or Foreign Equivalent) of a LICENSED
PRODUCT.
(ii)
Within
[*] months of the Effective Date, LICENSEE or sublicensee or AFFILIATE shall
INITIATE A PHASE II CLINICAL TRIAL (or Foreign Equivalent) of a LICENSED
PRODUCT.
(iii)
Within
[*] months of the Effective Date, LICENSEE or sublicensee or AFFILIATE shall
INITIATE A PHASE III CLINICAL TRIAL (or Foreign Equivalent) of a LICENSED
PRODUCT.
4.2
Should
all of LICENSEE, any sublicensee and any AFFILIATE fail to achieve any
applicable milestone dates set forth in 4.1(b)(i), (ii) or (iii) (as may be
amended pursuant to this 4.2), then LICENSEE shall, within thirty (30) days
after the applicable milestone date, provide PSRF with a written explanation
for
such delay. PSRF shall, in good faith, consider the explanation of LICENSEE
for
such delay, and if PSRF finds LICENSEE’s explanation reasonable, PSRF shall
grant, in writing, LICENSEE additional time to achieve the applicable milestone
detailed in 4.1(b) above, such amount of time to reasonably take into
consideration LICENSEE’s recommendations and the circumstances of each such
delay. Should the LICENSEE’s explanation of such delay include the written
requirement by the FDA or other applicable regulatory agency that LICENSEE
perform additional studies or trials, that LICENSEE reformulate or alter the
manufacturing process of any LICENSED
PRODUCT,
that
LICENSEE cease any clinical trial or redesign any clinical trial, or that
LICENSEE perform any other action or cease to perform any action or otherwise
delay the clinical development of any LICENSED PRODUCT, then such FDA or other
applicable regulatory agency evidence presented to PSRF by LICENSEE in
accordance with this paragraph shall be deemed “reasonable” by PSRF and PSRF
shall grant LICENSEE reasonable time extensions or milestone adjustments
accordingly. LICENSEE shall provide copies to PSRF of any such FDA or other
applicable regulatory agency documentation.
[*]
Confidential treatment requested; certain
information omitted and filed separately with the SEC.
8
4.3
Should
LICENSEE and PSRF be unable to reach agreement on a reasonable time extension
or
milestone adjustment pursuant to Article 4.2, or should PSRF contest the
reasonableness, good faith, or adequacy of proof for the stated reason for
such
failure, PSRF may declare LICENSEE to be in material breach unless LICENSEE
pays
a non-refundable monthly fee to PSRF (the "Penalty Fee"), [*] of such Penalty
Fee to be creditable against fees due to PSRF under Article 3.3. The initiation
of the Penalty Fee period shall commence upon written notification from PSRF
to
LICENSEE that PSRF has, in good faith, determined that LICENSEE is not using
its
commercially reasonable efforts to develop and commercialize any LICENSED
PRODUCT or LICENSED PROCESSES and, accordingly, will not extend or further
extend or alter any diligence milestone described in 4.1(b) above and remain
in
effect until achievement of any applicable milestone that caused LICENSEE to
be
in non-compliance with 4.1(b). The Penalty Fee shall be [*] Dollars ($[*])
in
the first month, increasing at a rate of [*] Dollars ($[*]) per month
thereafter, until achievement of any applicable milestone that caused LICENSEE
to be in non-compliance with 4.1(b). A representative payment schedule appears
in Appendix E. The first Penalty Fee shall be due within fourteen (14) days
of
such written notification from PSRF to LICENSEE. All subsequent Penalty Fees
shall be paid within fourteen (14) days of the end of the month for which
LICENSEE intends to delay notification of breach. PSRF shall not have the right
to terminate this License Agreement pursuant to this Article 4 as long as the
LICENSEE continues to make the monthly Penalty Fee payments. Upon achievement
of
any applicable milestone that caused LICENSEE to be in non-compliance with
4.1(b), LICENSEE shall no longer have the obligation to pay to PSRF the Penalty
Fee payments and PSRF shall no longer have the right to terminate the License
Agreement by reason of failure to comply with 4.1(b).
4.4
In
the
event LICENSEE has failed to make payments in accordance with Article 4.3,
then
LICENSEE shall be considered to be in financial breach or default and subject
to
termination pursuant to Paragraph 14.4 hereof.
4.5
A
Development Committee (the “Committee”) shall be organized to monitor the
clinical progress of the LICENSED PRODUCTS or LICENSED PROCESSES at the
LICENSEE’s expense. The Committee will consist of independent scientific and
technical thought leaders that are highly regarded by the scientific community
in the FIELD OF USE of each LICENSED PRODUCT or LICENSED PROCESS and at least
one representative from each of PSRF and the LICENSEE. The Committee will be
responsible for (i) making recommendations to the LICENSEE’s management relating
to the pre-clinical and clinical development strategy; (ii) analysis and
assessment of ongoing pre-clinical and clinical development of each LICENSED
PRODUCT or LICENSED PROCESS; and (iii) assisting the LICENSEE to prepare
pre-clinical and clinical development budgets. The actions and opinions of
the
Committee will be confidential, however, the PSRF representative may report
clinical updates to a designated senior official at PSRF who will agree to
keep
such information confidential. The Committee will meet at least two (2) times
per year. Said Committee shall meet within one (1) year of the Effective
Date.
[*]
Confidential treatment requested; certain
information omitted and filed separately with the SEC.
9
4.6
In
the
event that LICENSEE in its sole discretion decides to market one or more
LICENSED PRODUCTS or LICENSED PROCESSES in any country, then LICENSEE shall
exert reasonable efforts to have such LICENSED PRODUCTS or LICENSED PROCESSES
cleared for marketing by the responsible government agencies of that country
requiring such clearance. Should LICENSEE terminate this License Agreement,
LICENSEE agrees to assign its full right, title, and interest in and to such
market clearance application, including all data relating thereto, to PSRF
at no
cost to PSRF.
4.7
On
June
1, 2005, and each annual anniversary thereof, LICENSEE shall remit [*] Dollars
($[*]) to UNIVERSITY for sponsored research. The parties shall enter a sponsored
research agreement, substantially as set forth in Appendix D.
4.8
To
the
extent that the LICENSEE or any AFFILIATE of the LICENSEE is required to obtain
a license from a third party in order to practice the PATENT RIGHTS then the
parties shall re-negotiate in good faith over the stacking of royalties. After
completing its due diligence, LICENSEE is not aware of the need to obtain any
such license rights. It is understood by both parties that this is not intended
to cover currently anticipated combination therapies.
4.9
Except
as
otherwise provided herein, LICENSEE's failure to perform in accordance with
Article 4.5 shall constitute a material breach or default and shall be grounds
for termination of this License Agreement pursuant to Paragraph 14.5
hereof.
ARTICLE
5 - REPORTS AND RECORDS
5.1
LICENSEE
shall keep and preserve, in accordance with generally accepted accounting
principles and procedures, complete and accurate books, records and accounts
containing all particulars that may be necessary for the purpose of showing
the
amounts payable to PSRF hereunder including any amounts deducted by LICENSEE
under Article 4.8. Said books, records and accounts shall be kept at LICENSEE's
principal place of business or the principal place of business of the
appropriate division of LICENSEE to which this License Agreement relates. Said
books and supporting data shall be open, upon reasonable notice at all
reasonable times and places during business hours for five (5) years following
the end of the calendar year to which they pertain, to the inspection of PSRF
or
its agents for the purpose of verifying LICENSEE's royalty statement or
compliance in other respects with this License Agreement. Should such inspection
lead to the discovery of a greater than [*] ([*]%) discrepancy in reporting
to
PSRF's detriment, LICENSEE agrees to reimburse PSRF for the full cost of such
inspection.
[*]
Confidential treatment requested; certain
information omitted and filed separately with the SEC.
10
5.2
LICENSEE
shall, within sixty (60) days of March 31, June 30, September 30 and December
31, of each year, deliver to PSRF true and accurate reports, giving such
particulars of the business conducted by LICENSEE and its sublicensees during
the preceding calendar quarter under this License Agreement as shall be
pertinent to a royalty accounting hereunder. These reports shall be duly signed
by an authorized signatory of LICENSEE on behalf of LICENSEE and shall include
at least the following:
(a)
number
and type of LICENSED PRODUCTS manufactured and sold by LICENSEE and its
sublicensees;
(b)
total
xxxxxxxx for LICENSED PRODUCTS sold by LICENSEE and its
sublicensees;
(c)
listing
of applicable deduction as provided in Article 1.7 hereinabove;
(d)
royalties
due on sublicensee payments under Article 3.2 hereinabove;
(e)
total
royalties due; and
(f)
names
and
addresses of all sublicensees of LICENSEE.
5.3
With
each
such report submitted, LICENSEE shall pay to PSRF the royalties due and payable
under this License Agreement. If no royalties shall be due, LICENSEE shall
so
report.
5.4
LICENSEE
shall use the royalty-reporting sheet attached hereto as Appendix C, or a
similar document, to fulfill the royalty and reporting requirements of this
Article 5.
5.5
Financial
Dispute Resolution:
-Arbitration The parties agree that in the event of a dispute as to the amount
of payments owed hereunder, the dispute shall not be ripe for arbitration under
the terms of Article 13.2 until the parties have first attempted to resolve
the
matter through non-binding mediation as described in Article 13.1. Non-payment
of any resulting binding arbitration award shall be resolved in accordance
with
Article 13.2.
11
ARTICLE
6 - INTELLECTUAL PROPERTY AND PUBLICATION
6.1
Responsibility
for Patent Prosecution.
LICENSEE shall apply for, seek prompt issuance of, and maintain the PATENT
RIGHTS during the term of this Agreement. The ultimate responsibility for
prosecution, filing and maintenance of patent applications and patents which
issue therefrom shall be LICENSEE’s, provided however, that PSRF shall be given
the opportunity to review and comment upon the breadth and coverage of said
patent applications, and patent counsel jointly selected by the parties shall
use all due care to address and incorporate any comments offered by PSRF. In
addition, PSRF shall have the right to designate its own separate counsel,
at
PSRF’s expense, to review and comment upon the prosecution and drafting of the
jointly selected counsel and said comments shall also be given due
consideration. Appropriate documents (such as associate power of attorney)
shall
be executed to ensure that both parties have direct access to all patent
filings. PSRF shall be promptly furnished with all communications to and from
the Patent Office including, transmittal documents. During the patent
preparation, prosecution and maintenance process, PSRF shall have reasonable
opportunities to advise LICENSEE to ensure that said PATENT RIGHTS adequately
address PSRF’s needs. Both parties agree to provide reasonable cooperation to
each other to facilitate the application and prosecution of patents pursuant
to
this Agreement.
6.2
Abandonment.
The
LICENSEE may, in its discretion, elect to abandon any patent applications or
issued patent in the PATENT RIGHTS, in which case the LICENSEE shall have no
further royalty obligation to PSRF in respect of any LICENSED PRODUCTS and
LICENSED
PROCESSES
the
manufacture, use or sale of which is covered by an issued claim of such
abandoned PATENT RIGHTS. Prior to any such abandonment, the LICENSEE shall
give
PSRF at least sixty (60) days notice and a reasonable opportunity to take over
prosecution of such PATENT RIGHTS. In such event, PSRF shall have the right,
but
not the obligation, to commence or continue such prosecution and to maintain
any
such PATENT RIGHTS under its own control and at its expense and the LICENSEE
shall then have no royalty or other obligation to PSRF in respect of any
LICENSED PRODUCTS and LICENSED PROCESSES, the manufacture, use or sale of which
is covered by an issued claim of such PATENT RIGHTS. The LICENSEE agrees to
cooperate in such activities including execution of any assignments or other
documents necessary to enable PSRF to obtain and retain sole ownership and
control of such PATENT RIGHTS.
6.3
University
Publications.
In the
event that PSRF or the UNIVERSITY desires to publish or disclose, by written,
oral or other presentation, PATENT RIGHTS, KNOW-HOW, and Intellectual Property,
within the FIELD OF USE, related to the PATENT RIGHTS, then PSRF shall notify
the LICENSEE in writing by facsimile where confirmed by the receiving party,
and/or by certified or registered mail (return receipt requested) of their
intention at least sixty (60) days prior to any speech, lecture or other oral
presentation and at least sixty (60) days before any written or other
publication or disclosure. PSRF shall include with such notice a description
of
any proposed oral presentation or, in any proposed written or other disclosure,
a current draft of
such
proposed disclosure or abstract. LICENSEE may request that PSRF, no later than
thirty (30) days following the receipt of such notice, delay such
12
presentation,
publication or disclosure for up to an additional sixty (60) days in order
to
enable LICENSEE to file, or have filed on their behalf, a patent application,
copyright or other appropriate form of intellectual property protection related
to the information to be disclosed or request that PSRF do so. Upon receipt
of
such request to delay such presentation, publication or disclosure, PSRF or
the
UNIVERSITY shall arrange for a delay of such presentation, publication or
disclosure until such time as LICENSEE or PSRF have filed, or had filed on
its
behalf, such patent application, copyright or other appropriate form of
intellectual property protection in form and in substance reasonably
satisfactory to the LICENSEE or PSRF. If PSRF does not receive any request
from
LICENSEE to delay such presentation, publication or disclosure, PSRF may submit
such material for presentation, publication or other form of
disclosure.
6.4
PSRF
hereby authorizes the LICENSEE (a) to include in any NDA for a LICENSED PRODUCT,
as the LICENSEE may deem appropriate under the Federal Food, Drug and Cosmetic
Act (the “Act”), a list of patents included among the PATENT RIGHTS that relate
to such LICENSED PRODUCT and such other information as the LICENSEE in its
reasonable discretion believes is appropriate to be filed pursuant to the Act;
(b) to commence suit for any infringement of the PATENT RIGHTS under §271(e) of
Title 35 of the United States Code occasioned by the submission by a third
party
of an IND, or an Abbreviated New Drug Application (as that term is defined
in
the Act) for a LICENSED PRODUCT pursuant to §505(j) of the Act or an NDA for a
LICENSED PRODUCT pursuant to §505(b)(2) of the Act; and (c) subject to the
PSRF’s consent (which consent will not be unreasonably withheld or delayed), and
to exercise any rights that may be exercisable by PSRF as patent owner under
the
Act to apply for an extension of the term of any patent included among the
PATENT RIGHTS. In the event that applicable law in any other country of the
TERRITORY hereafter provides for the extension of the term of any patent
included among the PATENT RIGHTS in such country, upon request by and at the
expense of the LICENSEE, the PSRF shall use reasonable efforts to obtain such
extension or, in lieu thereof, shall authorize the LICENSEE or, if requested
by
the LICENSEE or its sublicensees to apply for such extension, in consultation
with PSRF. PSRF, at the LICENSEE’s expense, agrees to reasonably cooperate with
the LICENSEE or its sublicensees, as applicable, in the exercise of the
authorization granted herein or which may be granted pursuant to this ARTICLE
and will execute such documents and take such additional actions as the LICENSEE
may reasonably request in connection therewith, including, if necessary,
permitting itself to be joined as a proper party in any suit for infringement
brought by the LICENSEE under this ARTICLE. The provisions of this ARTICLE
shall
apply to any suit for infringement brought by the LICENSEE under clause (b)
above. In the event the LICENSEE decides not to commence suit for infringement
under clause (b) above, the LICENSEE will notify PSRF of its decision within
twenty five (25) days after the receipt of notice that the third party has
made
a certification described in § 505(b)(2)(A)(iv) or 505(j)(2)(A)(vii)(IV) of
the Act, so that PSRF may institute such litigation itself, if it wishes, at
its
own cost and expense.
13
ARTICLE
7 - INFRINGEMENT AND OTHER ACTIONS
7.1
LICENSEE
and PSRF shall promptly provide written notice, to the other party, of any
alleged infringement by a third party of any patent licensed under PATENT RIGHTS
and provide such other party with any available evidence of such infringement.
If necessary, a prima
facie determination
of infringement shall be made by an independent patent attorney satisfactory
to
both PSRF and LICENSEE.
7.2
During
the term of the License Agreement, LICENSEE shall have the initial right, but
not the obligation, to prosecute and/or defend, at its own expense, utilizing
counsel of its own choice, any infringement of, and/or challenge to, the PATENT
RIGHTS. In furtherance of such right, PSRF hereby agrees that PSRF may be
legally joined as a party in any such suit, without expense to PSRF. Before
LICENSEE commences an action hereunder, it shall consult with PSRF, and give
careful consideration to the views of PSRF and the potential impact of
litigation on PSRF. This shall include a face-to-face meeting between the
parties’ designated representatives prior to the initiation of litigation. No
settlement, consent judgment or other voluntary, final disposition of the suit
may be entered into without the consent of PSRF, which consent shall be timely
given and not unreasonably be withheld, unless such settlement does not
materially affect the rights of PSRF. LICENSEE agrees to keep PSRF reasonably
informed as to the status of any such action and to provide copies to PSRF,
upon
request by PSRF, of any papers or information relevant to the prosecution of
any
such action. LICENSEE shall timely inform PSRF of any offer for settlement
presented by a third party for any such action and LICENSEE shall consider
PSRF’s input in deciding whether or not to accept any such settlement offer. The
total cost of any such action, commenced or defended solely by the LICENSEE,
shall be borne by the LICENSEE. Any funds resulting from such action, whether
in
an out-of-court settlement or through a judgment in the courts will be used
first to pay LICENSEE the cost paid out by LICENSEE in taking such action.
Any
funds remaining therefrom will be treated as NET SALES under this License
Agreement, with the exception of amounts awarded for treble, exemplary or
punitive damages, which shall be divided equally between the
parties.
7.3
If
within
six (6) months after having been notified of any alleged infringement, LICENSEE
shall have been unsuccessful in persuading the alleged infringer to desist
and
shall not have brought and shall not be diligently prosecuting an infringement
action, or if LICENSEE shall notify PSRF at any time prior thereto of its
intention not to bring suit against any alleged infringer in the TERRITORY
for
the FIELD OF USE, then, and in those events only, PSRF shall have the right,
but
not the obligation, at its own expense and utilizing counsel of its own choice,
to prosecute any infringement of, and/or defend any challenge to, the PATENT
RIGHTS. Before PSRF commences any action hereunder, it shall consult with
LICENSEE and give careful consideration to the views of LICENSEE. Any funds
resulting from such action, whether in an out-of-court settlement or through
a
judgment in the courts will be paid to PSRF, with the exception of amounts
awarded for treble, exemplary or punitive damages, which shall be divided
equally between the parties.
7.4
In
the
event the parties hereto agree to share the costs of an action initiated
hereunder, any funds resulting from such action, whether in an out-of-court
settlement or through a
judgment in the courts will be used first to reimburse the parties costs paid
out in the action and the remainder shall be divided
equally.
14
7.5
In
the
event that a declaratory judgment action alleging invalidity or noninfringement
of any of the PATENT RIGHTS shall be brought against PSRF, LICENSEE, at its
option, shall have the right, within thirty (30) days after commencement of
such
action, to intervene and take over the sole defense of the action, at its own
expense; however, LICENSEE shall have the primary obligation to defend the
patent at its expense.
7.6
In
any
infringement suit either party may institute to enforce the PATENT RIGHTS
pursuant to this License Agreement, the other party hereto shall, at the request
and expense of the party initiating such suit, cooperate in all respects and,
to
the extent possible, have its employees testify when requested and make
available relevant records, papers, information, samples, specimens, and the
like.
7.7
LICENSEE,
during the exclusive period of this License Agreement, shall have the sole
right
in accordance with the terms and conditions herein to grant a sublicense to
an
infringer under Article 7.1 in the TERRITORY for the FIELD OF USE for future
use
of the PATENT RIGHTS. Any fees received shall be treated as sublicense fees
according to Article 3.2(ii).
7.8
Each
party hereto agrees that it and its AFFILIATES will not challenge the validity
of the PATENT RIGHTS.
ARTICLE
8 - REPRESENTATIONS, WARRANTIES AND INDEMNIFICATION
8.1
LICENSEE
shall at all times during the term of this License Agreement and thereafter,
indemnify, defend and hold PSRF, its trustees, directors, officers, employees
and affiliates, harmless against all claims, proceedings, demands and
liabilities of any kind whatsoever, including legal expenses and reasonable
attorneys' fees, arising out of the death of or injury to any person or persons
or out of any damage to property, or resulting from the production, manufacture,
sale, use, lease, consumption or advertisement of the LICENSED PRODUCTS or
LICENCED PROCESSES.
8.2
Prior
to
the first dosing of a patient with a LICENSED PRODUCT or LICENSED PROCESS,
in
the first clinical trial sponsored by the LICENSEE or its sublicensee or
AFFILIATE, LICENSEE shall obtain and carry in full force and effect commercial,
general liability insurance which shall protect LICENSEE and PSRF with respect
to events covered by Article 8.1 above. Such insurance shall be written by
a
reputable insurance company authorized to do business in the Commonwealth of
Pennsylvania, shall list PSRF and The UNIVERSITY as an additional named insured
thereunder, shall include product liability coverage and shall require thirty
(30) days written notice to be given to PSRF prior to any cancellation or
material change thereof. The limits of such insurance shall not be less than
[*]
Dollars ($[*]) per occurrence with an
aggregate of [*] Dollars ($[*]). LICENSEE shall provide PSRF with Certificates
of Insurance evidencing the same.
[*]
Confidential treatment requested; certain
information omitted and filed separately with the SEC.
15
(a)
Prior to the first commercial sale of a LICENSED PRODUCT or LICENSED PROCESS,
PSRF and LICENSEE shall agree upon appropriate levels of insurance coverage.
8.3
EXCEPT
AS
OTHERWISE EXPRESSLY SET FORTH IN THIS LICENSE AGREEMENT, PSRF, ITS TRUSTEES,
DIRECTORS, OFFICERS, EMPLOYEES, AND AFFILIATES MAKE NO REPRESENTATIONS AND
EXTEND NO WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING BUT
NOT
LIMITED TO WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE,
VALIDITY OF PATENT RIGHTS CLAIMS, ISSUED OR PENDING, AND THE ABSENCE OF LATENT
OR OTHER DEFECTS, WHETHER OR NOT DISCOVERABLE. NOTHING IN THIS LICENSE AGREEMENT
SHALL BE CONSTRUED AS A REPRESENTATION MADE OR WARRANTY GIVEN BY PSRF THAT
THE
PRACTICE BY LICENSEE OF THE LICENSE GRANTED HEREUNDER SHALL NOT INFRINGE THE
PATENT RIGHTS OF ANY THIRD PARTY. IN NO EVENT SHALL PSRF, ITS TRUSTEES,
DIRECTORS, OFFICERS, EMPLOYEES AND AFFILIATES BE LIABLE FOR INCIDENTAL OR
CONSEQUENTIAL DAMAGES OF ANY KIND, INCLUDING ECONOMIC DAMAGE OR INJURY TO
PROPERTY AND LOST PROFITS, REGARDLESS OF WHETHER PSRF SHALL BE ADVISED, SHALL
HAVE OTHER REASON TO KNOW, OR IN FACT SHALL KNOW OF THE
POSSIBILITY.
8.4
Intellectual
Property. PSRF represents that (i) PSRF has the sole right to grant to LICENSEE
the rights granted herein and the rights are unencumbered by any liens (ii)
to
the best of its knowledge, PSRF is not aware of any third party patents that
would block the commercialization of LICENSED PRODUCTS or LICENSED PROCESSES;
(iii) PSRF has not received any notice, including written notice, alleging
any
infringement by PSRF of any intellectual property rights of a third party in
respect of the PATENT RIGHTS; and (iv) to the knowledge of PSRF, the rights
granted under this Agreement do not conflict with the rights granted by PSRF
to
any other third party.
8.5
PSRF
represents and warrants that, to the best of its knowledge:
a)
PSRF has disclosed to LICENSEE all potential and existing PATENT RIGHTS in
the
control of PSRF or in control of a third party known to PSRF which may be needed
to commercialize any LICENSED PRODUCT or LICENSED PROCESS;
b)
Appendix B lists all patents and patent applications owned by PSRF that cover
the LICENSED PRODUCT or LICENSED PROCESS, and PSRF will during the term of
this
Agreement, promptly upon request, provide LICENSEE with an updated version
of
Appendix A and B; and
c)
PSRF is the exclusive owner of the patents and patent applications listed in
Appendix B as of the date hereof and has the sole and exclusive right to license
the PATENT RIGHTS and all other intellectual property rights of the UNIVERSITY.
16
8.6
PSRF
shall at all times during the term of this License Agreement and thereafter,
indemnify, defend and hold LICENSEE, its AFFILIATES, and each of their
respective officers, directors, agents, employees, shareholders, successors
and
assigns harmless against all claims, proceedings, demands and liabilities of
any
kind whatsoever, including legal expenses and reasonable attorneys' fees,
arising out of: activities conducted by PSRF; breach by PRSF of this agreement;
or PSRF's material violation of any applicable law, including any foreign,
federal, state or local law or judicial decision.
8.7
Both
parties hereby represent and warrant the following:
(a)
Neither
the execution or delivery of this Agreement nor the performance by either party
to this Agreement of its duties and other obligations hereunder violate or
will
violate any statute, law, determination or award, or conflict with or constitute
a default or breach of any covenant or obligation under (whether immediately,
upon the giving of notice or lapse of time or both) any prior agreement,
contract, policy or other instrument to which the parties are
bound.
(b)
Each
party hereto has the full right, power and legal capacity to enter and deliver
this Agreement and to perform its duties and other obligations hereunder.
This Agreement constitutes the legal, valid and binding obligation of each
party
hereto enforceable against it in accordance with its terms. No approvals
or consents of any persons or entities are required for either party to execute
and deliver this Agreement or perform their duties and other obligations
hereunder and contemplated herein.
ARTICLE
9 - EXPORT CONTROLS
9.1
LICENSEE
acknowledges that it is subject to United States export laws and regulations,
and that a license thereunder may be required. PSRF neither represents that
a
license shall not be required nor that, if required, it shall be issued, and
all
costs thereof shall be borne by LICENSEE.
ARTICLE
10 - NON-USE OF NAMES
10.1
LICENSEE
shall not use the names or trademarks of UNIVERSITY, PSRF, or any of their
employees, or any adaptation thereof, in any advertising, promotional or sales
literature without prior written consent obtained from PSRF, in each case,
except that LICENSEE may, without prior written consent, state that it is
licensed by PSRF, under one or more of the patents and/or applications
comprising the PATENT RIGHTS. Further, PSRF acknowledges and agrees that
LICENSEE may use the names of PSRF and UNIVERSITY in various documents used
by
LICENSEE for capital raising and financing without such prior written consent
where the use of such names may be required by law, provided that LICENSEE
shall
promptly provide copies of any such documents, including private placement
memoranda, prospectus documents, etc.
17
10.2
PSRF
shall not use the names or trademarks of LICENSEE, or any of their employees,
or
any adaptation thereof, in any advertising, promotional or sales literature
without prior written consent obtained from LICENSEE, in each case, except
that
PSRF may, without prior written consent, state that it has licensed to LICENSEE,
one or more of the patents and/or applications comprising the PATENT
RIGHTS.
ARTICLE
11- PAYMENTS, NOTICES AND OTHER COMMUNICATIONS
11.1
Any
payment, notice or other communication pursuant to this License Agreement shall
be sufficiently made or given on the date of mailing if sent to such party
by
certified or registered first class mail, postage prepaid, addressed to it
at
its address below or as it shall designate by written notice given to the other
party as follows:
In
the
case of THE PENN STATE RESEARCH FOUNDATION:
President
The
Penn
State Research Foundation
c/o
Intellectual Property Xxxxxx
000
Xxxxxxxxxx Xxxxxx
Xxxxxxxxxx
Xxxx, XX 00000-0000
In
the
case of LICENSEE:
000
Xxxxxxx Xxxxxx, 00xx
Xxxxx
Xxx
Xxxx,
XX 00000
Attn:
Chief Executive Officer
ARTICLE
12 - ASSIGNMENT
12.1
This
Agreement and the rights and duties appertaining hereto may not be assigned
by
either party without first obtaining the written consent of the other which
consent shall not be unreasonably withheld. Any such purported assignment,
without the written consent of the other party, shall be null and of no effect.
Notwithstanding the foregoing, each party may assign this Agreement with prior
written notification to the other party, but without the consent of the other
party (i) to a purchaser, merging or consolidating corporation, or acquirer
of
substantially all of the assignor’s assets or business and/or pursuant to any
reorganization, including those qualifying under section 368 of the Internal
Revenue Code of 1986, as amended, as may be in effect at such time, or (ii)
to
an AFFILIATE of the assignor, provided that any successor entity must have
a net
asset value (using GAAP) of at least ten (10) million dollars.
18
ARTICLE
13 - DISPUTE RESOLUTION
13.1
Except
for the right of either party to apply to a court of competent jurisdiction
for
a temporary restraining order, a preliminary injunction, or other equitable
relief to preserve the status
quo
or
prevent irreparable harm, any and all claims, disputes or controversies arising
under, out of, or in connection with this License Agreement, including any
dispute relating to patent validity or infringement, which the parties shall
be
unable to resolve within sixty (60) days, shall be mediated in good faith.
The
party raising such dispute shall promptly advise the other party of such claim,
dispute or controversy in a writing, which describes in reasonable detail the
nature of such dispute. By not later than five (5) business days after the
recipient has received such notice of dispute, each party shall have selected
for itself a representative who shall have the authority to bind such party,
and
shall additionally have advised the other party in writing of the name and
title
of such representative. By not later than ten (10) business days after the
date
of such notice of dispute, the party against whom the dispute shall be raised
shall select a mediation firm in Pennsylvania and such representatives shall
schedule a date with such firm for a mediation hearing. The parties shall enter
into good faith mediation and shall share the costs equally. If the
representatives of the parties have not been able to resolve the dispute within
fifteen (15) business days after such mediation hearing, the parties shall
have
the right to pursue any other remedies legally available to resolve such dispute
in either the Centre County Court of Common Pleas or in the United States
District Court for the Middle District of Pennsylvania, to whose jurisdiction
for such purposes PSRF and LICENSEE each hereby irrevocably consents and
submits.
13.2
Any
and
all claims, disputes or controversies in relation to the amount of any royalty
or other payments owed by LICENSEE pursuant to Article 3, which the parties
hereto shall be unable to resolve within sixty (60) days, shall be mediated
in
good faith. The party raising such dispute shall promptly advise the other
party
of such claim, dispute or controversy in writing which describes in reasonable
detail the nature of such dispute. By not later than five (5) business days
after the recipient has received such notice of dispute, each party shall have
selected for itself a representative who shall have the authority to bind such
party, and shall additionally have advised the other party in writing of the
name and title of such representative. By not later than ten (10) business
days
after the date of such notice of dispute, the party against whom the dispute
shall be raised shall select a mediation firm in Pennsylvania and such
representatives shall schedule a date with such firm for a mediation hearing
not
to exceed one (1) day in length, and less where applicable. The parties shall
enter into good faith mediation and shall share the costs equally. If the
representatives of the parties have not been able to resolve the dispute within
fifteen (15) business days after such mediation hearing, it will be finally
decided by an appropriate method of alternate dispute resolution, in
Pennsylvania, as mutually agreed by the parties including without limitation,
private arbitration, conducted in accordance with the applicable, then current,
procedures of the American Arbitration Association. The arbitration panel will
include members generally knowledgeable in the FIELD OF USE of the INVENTIONS
and oncology. Judgment upon any such award rendered may be entered into the
highest court or forum having jurisdiction, state or federal. The binding
decision of the arbitration board can be enforced by a court of law having
jurisdiction upon the parties.
19
ARTICLE
14 - TERM AND TERMINATION
14.1
LICENSEE
shall have the right to terminate this Agreement at any time on sixty (60)
days
notice to PSRF, and upon payment of all amounts due PSRF through the effective
date of the termination.
14.2
Unless
earlier terminated as hereinafter provided, this License Agreement shall
continue until the end of the life of the last to expire patent licensed under
the PATENT RIGHTS, on a country-by-country basis. From and after the expiration
of such PATENT RIGHTS, LICENSEE will have a paid up, royalty-free license under
the PATENT RIGHTS to make, have made, use, have used, sell and have sold
LICENSED PRODUCTS and to practice and have practiced the LICENSED
PROCESSES.
14.3
Financial
Solvency of LICENSEE.
LICENSEE agrees that as a part of its material inducement to PSRF to enter
this
License Agreement, it shall provide PSRF with at least ninety (90) days written
notice hereunder of its intent to file a petition in Bankruptcy, whether it
be
for a Chapter 7, 11, 13 or any other such petition. LICENSEE agrees and
understands that PSRF has an obligation to UNIVERSITY, a land grant institution
under the Xxxxxxx Act, to license the PATENT RIGHTS pursuant to terms and
conditions which maximize the public benefit. PSRF shall have the right to
immediately terminate this License Agreement by giving written notice to
LICENSEE, in the event LICENSEE does any of the following: a) provides notice
hereunder of its intent to file (or does actually file without providing said
notice) a petition in bankruptcy, b) attempts to make an assignment of this
Agreement for the benefit of creditors, c) discontinues or dissolves its
business, or d) if a receiver is appointed by a court of competent jurisdiction
for LICENSEE.
14.4
Financial
Breach.
Except
as provided in Article 13.2, in the event LICENSEE has breached its obligations
to pay royalties or fees under Article 3 or Article 4.3 of this License
Agreement, and such fees are not subject to a good xxxxx xxxx fide dispute
between the parties, and/or fails to file royalty reports in accordance with
Article 5 of this License Agreement, (hereafter “Financial Breach”) PSRF shall
provide LICENSEE with written notice of said breach, and LICENSEE shall have
a
period of thirty (30) days to cure said breach. In the event LICENSEE does
not
fully cure the breach within that thirty (30) day period, and fails within
that
thirty (30) days to commence mediation pursuant to Article 13.1 of this License
Agreement alleging grounds for its non-payment thereof, this License Agreement
shall be automatically terminated without further notice or action by PSRF.
If a
dispute regarding termination is addressed according to Article 13, this license
shall remain in full force and effect until such dispute is settled in a manner
that is not further appealable or not appealed.
14.5
Failure
of Other Performance.
Upon any
material breach of performance under this License Agreement, by LICENSEE, other
than those occurrences set out in Articles 14.3 or 14.4 hereinabove, which
shall
always take precedence in that order over any material breach or default
referred to in this Article 14.5, PSRF shall have the right to terminate this
License Agreement and the rights, privileges and license granted hereunder
effective sixty (60) days after PSRF
first notifies LICENSEE of the alleged breach under the notice provisions
contained in Article 14 of this License Agreement. Such termination shall become
effective upon final notification by PSRF after the sixty (60) days, unless
LICENSEE shall have fully cured any such material breach or default prior to
the
expiration of the sixty (60) day period. In the event of a dispute as to whether
LICENSEE has cured the alleged breach, the matter shall be resolved pursuant
to
Article 13 of this License Agreement. If a dispute regarding termination is
addressed according to Article 13, this license shall remain in full force
and
effect until such dispute is settled in a manner that is not further appealable
or not appealed.
20
14.6
Upon
termination of this License Agreement for any reason, nothing herein shall
be
construed to release either party from any obligation that matured prior to
the
effective date of such termination; and Articles 1, 8, 9, 10, 16, 17 and
Articles 14.5 and 14.6 shall survive any such termination. LICENSEE and any
sublicensee thereof may, however, after the effective date of such termination,
sell all LICENSED PRODUCTS, and complete LICENSED PRODUCTS in the process of
manufacture at the time of such termination and sell the same, provided that
LICENSEE submit the reports required by Article 5 hereof.
14.7
Upon
termination of this Agreement other than by expiration in accordance with
Article 14, any and all sublicenses shall survive such termination.
Notwithstanding the foregoing, if LICENSEE believes that PSRF has terminated
this Agreement for the primary purpose of doing business directly with the
sublicensee, the termination may be disputed under the provisions of Article
13.
ARTICLE
15 - AGENCY
15.1
Nothing
herein shall be deemed to establish a relationship of principal and agent
between PSRF and the LICENSEE, nor any of their agents or employees for any
purpose whatsoever.
ARTICLE
16. CONFIDENTIALITY
16.1
Except
as
expressly authorized under article 6.3, any proprietary or confidential
information relating to the PATENT RIGHTS within the FIELD OF USE, (including
but not limited to KNOW-HOW and patent prosecution documents relating to PATENT
RIGHTS) collectively constitute the “Confidential Information." LICENSEE and
PSRF agree that they will not use the Confidential Information for any purpose
unrelated to this Agreement, and will hold it in confidence during the term
of
this Agreement and for a period of [*] years after the termination or expiration
date of this Agreement. LICENSEE shall not disclose Confidential Information
or
permit its disclosure to any third party (except to those of its employees,
consultants, or agents who are bound by the same obligation of confidentiality
as LICENSEE is bound by pursuant to this Agreement). However, such undertaking
of confidentiality by LICENSEE shall not apply to any information or data
which:
[*]
Confidential treatment requested; certain
information omitted and filed separately with the SEC.
21
16.1.1
LICENSEE
receives at any time from a third-party lawfully in possession of same and
having the right to disclose same.
16.1.2
Is,
as of
the date of this Agreement, in the public domain, or subsequently enters the
public domain through no fault of LICENSEE.
16.1.3
Is
independently developed by LICENSEE as demonstrated by written evidence without
reference to information disclosed to LICENSEE by PSRF.
16.1.4
Is
disclosed pursuant to the prior written approval of PSRF.
16.1.5
Is
required to be disclosed pursuant to law or legal process (including, without
limitation, to a governmental authority) provided, in the case of disclosure
pursuant to legal process, reasonable notice of the impending disclosure is
provided to PSRF.
ARTICLE
17 - MISCELLANEOUS PROVISIONS
17.1
Entire
Agreement.
This
License Agreement embodies the entire understanding of the parties and shall
supersede all previous communications, representations, or undertakings, either
verbal or written, between the parties relating to the subject matter
hereof.
17.2
Amendment.
This
License Agreement may be amended only by a written agreement embodying the
full
terms of the amendment signed by authorized representatives of both
parties.
17.3
Severability.
Should
any provision of this License Agreement be held to be illegal, invalid or
unenforceable, by any court of competent jurisdiction, such provision shall
be
modified by such court in compliance with the law and, as modified, enforced.
The remaining provisions of this License Agreement shall be construed in
accordance with the modified provision and as if such illegal, invalid or
unenforceable provision had not been contained herein.
17.4
No
Strict Construction.
The
language used in this License Agreement shall be deemed to be the language
chosen by both parties hereto to express their mutual intent and no rule of
strict construction against either party shall apply to any term or condition
of
this License Agreement.
17.5
Relationship
of Parties.
Nothing
contained in this License Agreement shall be construed as creating a
partnership, joint venture, agency or an association of any kind.
17.6
No
Waiver.
The
failure of one party hereto to enforce at any time any of the provisions of
this
License Agreement, or any rights in respect thereto, or to exercise any election
herein provided, shall in no way be considered to be a waiver of such provision,
rights or elections or in any way to affect the validity of this License
Agreement, or excuse a similar subsequent failure to perform any such term
or
condition by the other party. Any waiver must be in writing.
22
17.7
Interpretation.
The
headings of several Articles contained herein are inserted for convenience
of
reference only, and are not intended to be a part of or to affect the meaning
or
interpretation of this License Agreement.
17.8
Governing
Law.
This
License Agreement shall be governed by and construed in accordance with the
laws
of the Commonwealth of Pennsylvania without giving effect to any choice of
law
or conflict of law provision or rule that would cause the application of the
laws of any jurisdiction other than the Commonwealth of Pennsylvania, except
that questions affecting the construction and effect of any patent shall be
determined by the law of the country in which the patent was
granted.
17.9
Product
Marking.
LICENSEE agrees to xxxx the LICENSED PRODUCTS sold in the United States with
all
applicable United States patent numbers. All LICENSED PRODUCTS shipped to or
sold in other countries shall be marked in such a manner as to conform with
the
patent laws and practices of the country of manufacture or sale.
23
IN WITNESS WHEREOF, the parties hereto, intending to be legally bound hereby, have each caused a duly authorized representative to execute this License Agreement on the day and year set forth below.
________________________________
By:
/s/
Xxxxxx Xxxxx
Name:
Xxxxxx Xxxxx
Title:
President
& CEO
Date:
3/15/05
THE
PENN
STATE RESEARCH FOUNDATION
(PSRF)
By:
/s/
Xxxxx X. Xxxxxxxx
Name:
Xxxxx
X. Xxxxxxxx
Title:
Treasurer
Date:
March
16, 20005
THE
PENNSYLVANIA STATE UNIVERSITY
Read
and
acknowledged specifically regarding Article 6.3.
By:
/s/
Xxxxx X. Xxxxxxxx
Name:
Xxxxx
X. Xxxxxxxx
Title:
Assistant
Treasurer
Date:
March
16, 2005
24
APPENDIX
A: INVENTIONS
|
PSU
Invention
Disclosure
Number
|
Invention
Title
|
Inventors
|
|
96-1565
|
“Opioid
Growth Factor and Cancer”
|
Xx.
Xxx X. Xxxxx, Xx. Xxxxxxxx X. XxXxxxxxxx and Xx. Xxxx X.
Xxxxx
|
|
2003-2839
|
“Combination
Therapy with Opioid Growth Factor and Taxanes for the Treatment of
Cancer”
|
Xx.
Xxx X. Xxxxx, Xx. Xxxxxxxx X. XxXxxxxxxx
|
|
2004-2890
|
“Combined
Therapy with Opioid Growth Factor and Gemcitabine for the Treatment
of
Cancer”
|
Xx.
Xxx X. Xxxxx, Xx. Xxxxxxxx X.
XxXxxxxxxx
|
25
APPENDIX
B: PATENT RIGHTS
|
PSU
Invention
Disclosure Number |
Invention
Title
|
Intellectual
Property / Patent Status
|
|
96-1565
|
“Opioid
Growth Factor and Cancer”
|
U.S.
Patent No.[*]
U.S.
Patent No. [*]
|
|
2003-2839
2004-2890
|
“Combination
Therapy with Opioid Growth Factor and Taxanes for the Treatment of
Cancer”
“Combined
Therapy with Opioid Growth Factor and Gemcitabine for the Treatment
of
Cancer”
|
U.S.
Provisional Patent No. [*] filed
[*]
|
[*]
Confidential treatment requested; certain information omitted and
filed separately with the SEC.
26
APPENDIX
C
[LICENSEE]/PSRF
License Agreement Royalty Report for the Period
____________through__________
Instructions:
Please fill in all boxes (write "none" if not applicable), and sign and date
at
bottom. All Article numbers refer to the License Agreement.
Answer
questions 1 and 2 (AND SIGN AND DATE AT BOTTOM) EVEN IF THERE HAS BEEN NO
ACTIVITY in reporting period.
1.
Number of transactions: by
[LICENSEE] r
by
Sublicensees r
2.
Any new sublicenses entered into during the period? yes
r no r
If
yes,
attach separate sheet listing names and addresses of sublicensees, and attach
sublicense agreements.
Answer
this Article only
if there has been LICENSED PRODUCT/PROCESS activity or non-running royalty
sublicensee payment in reporting period.
|
Date
of Transaction
|
Type
of Transaction
|
By
______ or Sublicensee?
(if
latter, identify)
|
Product
or Process Type (name and id number)
|
Total
Xxxxxxxx
|
Deductions
per § __ (specify type)
|
Royalties
Due
|
Customer
Name and Address
|
Number
of
Royalty Report continuation sheets attached________
Non-running
royalty payments received from sublicensees (per §___): $__________, of which
$________ (__%) goes to PSRF.
Specify
each sublicensee and amount of payment on separate sheet.
Total
amount enclosed $_______________
[LICENSEE]
By:
Date:
Name
and
Title:
27
APPENDIX
C
Continuation
sheet number _____to [LICENSEE]/PSRF License Agreement Royalty Report for the
Period _____________ through ______________
Use
this
sheet if there are additional transactions to report.
|
Date
of Transaction
|
Type
of Transaction
|
By
_____ or Sublicensee? (if latter, identify)
|
Product
or Process Type (name and id number)
|
Total
Xxxxxxxx
|
Deductions
per §__ (specify type)
|
Royalties
Due
|
Customer
Name and Address
|
28
APPENDIX
D
29
APPENDIX
E
|
Month
Number
|
Monthly
Payment
|
Cumulative
|
|
1
|
[*]
|
[*]
|
|
2
|
[*]
|
[*]
|
|
3
|
[*]
|
[*]
|
|
4
|
[*]
|
[*]
|
|
5
|
[*]
|
[*]
|
|
6
|
[*]
|
[*]
|
|
7
|
[*]
|
[*]
|
|
8
|
[*]
|
[*]
|
|
9
|
[*]
|
[*]
|
|
10
|
[*]
|
[*]
|
|
11
|
[*]
|
[*]
|
|
12
|
[*]
|
[*]
|
|
13
|
[*]
|
[*]
|
|
14
|
[*]
|
[*]
|
|
15
|
[*]
|
[*]
|
|
16
|
[*]
|
[*]
|
|
17
|
[*]
|
[*]
|
|
18
|
[*]
|
[*]
|
|
19
|
[*]
|
[*]
|
|
20
|
[*]
|
[*]
|
|
21
|
[*]
|
[*]
|
|
22
|
[*]
|
[*]
|
|
23
|
[*]
|
[*]
|
|
24
|
[*]
|
[*]
|
This
schedule is provided for purposes of clarity and is in no way intended to limit
the amount or duration of the Penalty Fee Payments.
[*]
Confidential treatment requested; certain
information omitted and filed separately with the SEC.
30
