License Agreement - University of Southern California and Bio-Management Inc.
LICENSE AGREEMENT
1. INTRODUCTION
THIS AGREEMENT is between the UNIVERSITY OF SOUTHERN CALIFORNIA,
(hereinafter USC) a California nonprofit corporation with its principal place of
business at University Park, Los Angeles, California 90089, and Bio-Management,
Inc., a Nevada corporation, with its principal place of business at 4 Hook Road,
Sharon Hill, PA 19079 (hereinafter Licensee).
WHEREAS USC warrants that it is the owner and that it has the right to
exclusively license those inventions which are the subject matter of the patent
applications listed in Appendix A and of which the inventors are Peter Brooks
and Dorothy Rodrequez of USC (hereinafter Inventor);
WHEREAS Licensee desires to obtain an exclusive license in the defined
FIELD OF USE to manufacture and market products utilizing the inventions as
hereinafter defined;
WHEREAS, USC is willing to grant a worldwide, exclusive license in the
defined FIELD OF USE to Licensee subject to the terms, conditions, limitations,
and restrictions set forth below;
NOW, THEREFORE, in consideration of the covenants herein contained, the
parties agree as follows:
2. DEFINITIONS
For all purposes of this Agreement the following terms shall have the
meanings specified below:
a. The term "PATENT" or "PATENTS" shall mean any and all patent
applications listed in Appendix A (Appendix A may be added to from time to time
by USC and USC shall notify Licensee of any such additions), any and all patents
issued thereon or any continuation, division, extensions or reissue thereof, and
any and all foreign patents issuing from any application filed which corresponds
to claims contained in any of the foregoing patents or applications.
b. "PRODUCT" or "PRODUCTS" shall mean any article, composition,
apparatus, substance, chemical, material, method or service which is made, used,
distributed or sold by Licensee which:
i. is covered in whole or in part by one or more pending
or unexpired claims contained in a PATENT in the country in
which the PRODUCT(S) is made, used, distributed or sold;
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ii. is manufactured using a method or process which is
covered in whole or in part by one or more pending or
unexpired claims contained in a PATENT in the country in which
(a) the PRODUCT(S) is made, used, distributed or sold, or (b)
the method or process is used or sold; or
iii. the use of which is covered in whole or in part by
one or more pending or unexpired claims contained in a PATENT
in the country in which (a) the PRODUCT(S) is made, used,
distributed or sold, or (b) the method or process is used or
sold;
A PRODUCT is covered by a pending or unexpired claim of a
PATENT if in the course of manufacture, use, distribution or sale, it would, in
the absence of this Agreement, infringe one or more claims of the PATENT which
has not been held invalid by a court from which no appeal can be taken.
c. "FIELD OF USE" shall mean any fields of use.
d. "NET SALES PRICE" shall mean the gross billing price of any
PRODUCT actually received by Licensee or its SUBLICENSEE for the sale or
distribution of any PRODUCT, less the following amounts actually paid by
Licensee or SUBLICENSEE:
i. discounts allowed;
ii. returns;
iii. transportation charges or allowances;
iv. packing and transportation packing material costs
(not including product containers or product packing
containers as manufactured by the Company);
v. customs and duties charges; and
vi. sales, transfer and other excise taxes or other
governmental charges levied on or measured by the
sales but no franchise or income tax of any kind
whatsoever.
In addition to the aforementioned deductions, Licensee may
divert royalties otherwise payable to USC to the escrow account referenced in
Paragraph 7.a. herein.
Every commercial use or disposition of any PRODUCT, in
addition to a bona fide sale to a customer, shall be considered a sale of such
PRODUCT. The NET SALES PRICE, in the case of a use or disposition other than a
bona fide sale, shall be equivalent the then payable NET SALES PRICE of such
PRODUCT in an arm's length transaction.
e. "SUBLICENSEE" shall mean any third party licensed by Licensee
to make, or sell any PRODUCT in accordance with the terms of this Agreement.
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f. "EFFECTIVE DATE" of this Agreement shall be the date when the
last party has signed this Agreement.
3. LICENSE PHASE
a. In consideration of the license fee and royalties, and subject
to the terms and conditions, as set forth in this Agreement USC hereby grants to
Licensee:
i. the exclusive worldwide license in the FIELD OF USE
to use the PATENT to make, use and sell and to have made, have sold and
sublicense (pursuant to paragraph 3.a.ii.) the PRODUCT(S); and
ii. the right to grant sublicenses to any PATENT licensed
exclusively hereunder, provided that any SUBLICENSEE agrees to be bound by the
terms and conditions of this Agreement applicable to SUBLICENSEES.
b. All licenses pursuant to 3.a. and 3.b. to inventions conceived
or first actually reduced to practice during the course of research funded by a
U.S. federal agency are subject to the rights, conditions and limitations
imposed by U.S. law, including but not limited to the following:
i. The words "exclusive license" as used herein shall
mean exclusive except for the royalty free non-exclusive license granted to the
U.S. government by USC pursuant to 35 USC Section 202(c)(4) for any PATENT
claiming an invention subject to 35 USC Section 201 and except for the rights of
USC and Inventors as set forth in Paragraph 5.
ii. Licensee agrees that PRODUCTS used or sold in the
United States shall be manufactured substantially in the United States, unless a
written waiver is obtained in advance from the relevant U.S. federal agency.
c. In addition to the royalty referred to in Paragraph 4 the
Licensee shall pay USC a license fee of Two Hundred and Fifty Thousand Dollars
($250,000) payable within ten (10) days of the EFFECTIVE DATE.
4. ROYALTY
a. On all sales of PRODUCTS anywhere in the world by Licensee or
any SUBLICENSEE, Licensee shall pay USC a royalty of [***] the NET
SALES PRICE.
b. The Licensee will pay an annual minimum royalty. The minimum
royalty on the PRODUCTS will be Ten Thousand Dollars ($10,000) commencing on the
third anniversary of the EFFECTIVE DATE of this agreement, and shall be due on
or before each subsequent anniversary of the EFFECTIVE DATE for each succeeding
year up to the date of expiration of the last PATENT. Should Licensee fail to
make earned royalty payments sufficient to meet said minimum royalty
requirements, it may pay the
*** Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to the
omitted portions.
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difference between the earned royalty and the minimum royalty requirement to
keep this Agreement in force.
c. Licensee shall pay such royalties to USC on a calendar quarter
basis. With each quarterly payment, Licensee shall deliver to USC a full and
accurate accounting to include at least the following information:
i. Quantity of each PRODUCT sold (by country) by
Licensee and its SUBLICENSEES;
ii. Total receipts for each PRODUCT (by country);
iii. Quantities of each PRODUCT used by Licensee and its
SUBLICENSEES;
iv. Names and addresses of SUBLICENSEES of Licensee;
v. Total number of PRODUCTS manufactured (by country);
and
vi. Total royalties payable to USC.
d. In each year the amount of royalty due shall be calculated
quarterly as of March 31, June 30, September 30 and December 31 and shall be
paid quarterly within the thirty next (30) days following such date. Every such
payment shall be supported by the accounting prescribed in Paragraph 5.d. and
shall be made in United States currency. Whenever for the purpose of calculating
royalties conversion from foreign currency shall be required, such conversion
shall be at the rate of exchange thereafter published in the Wall Street Journal
for the business day closest to the applicable end of calendar quarter.
e. The royalty payments due under this Agreement shall, if
overdue, bear interest until payment at a per annum rate equal to one and a half
percent (1.5%) above the prime rate in effect on the due date, not to exceed the
maximum permitted by law. The payments of such interest shall not preclude USC
from exercising any other rights it may have as a consequence of the lateness of
any royalty payment.
5. RIGHTS RETAINED BY UNIVERSITY
Notwithstanding the exclusive license granted in Paragraph 4a, USC and
Inventors will have the absolute, nontransferable right to use the technology
covered by the PATENTS and all improvements thereof, for conducting research and
educational purposes.
6. PATENT PROSECUTION
a. USC shall file, prosecute and maintain, during the course of
this Agreement, the patent
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applications and patents listed in Appendix A. Should Licensee require the
filing of foreign patents, USC shall take responsibility for filing, prosecuting
and maintaining said foreign patents. Licensee shall have reasonable
opportunities to advise USC and shall cooperate with USC in such prosecution,
filing and maintenance. USC shall furnish to License copies of documents
relevant to such prosecution, filing and maintenance.
b. Licensee shall reimburse all reasonable legal expenses
incurred and paid by USC in filing, prosecuting and maintaining the U.S. and
foreign applications listed (or to be listed pursuant to Paragraph 2a.) in
Appendix A, whether such expenses were incurred before or after the date of this
Agreement. These legal expenses shall include the attorneys' and agents' fees,
foreign filing fees and out-of-pocket costs associated with responding to office
actions and any other fees and costs directly related to obtaining and/or
maintaining patent protection in the countries listed in Appendix A. Licensee
shall advance payments of maintenance fees and annuities as part of such legal
expenses to be reimbursed by Licensee within thirty (30) days of request by USC,
unless Licensee is advised otherwise by timely notice from USC.
c. If the Licensee elects (i) not to pursue a PATENT or (ii) to
terminate the prosecution or maintenance of a PATENT in any country, the
Licensee surrenders its right to make, use or sell PRODUCTS covered by the
non-elected PATENT in that particular country and shall grant to USC the
exclusive rights previously granted to Licensee, without limitation, for that
country. Licensee agrees to execute all necessary documents to carry out this
grant of rights to USC. Payments referred to in Paragraphs 7.a. and 7.b shall
not be refunded upon such non-election or termination.
7. PATENT INFRINGEMENT
a. Defensive Controversy.
Licensee shall promptly notify USC of all claims, allegations and
notifications of infringement of third party patents. Except for the placing in
escrow of a portion of royalties as referred to hereinafter, USC shall have no
obligation or liability in the event that legal action is brought against
Licensee for patent infringement. Such obligation and liability shall be borne
by Licensee. Licensee may choose legal counsel and defend the patent
infringement lawsuit. During such lawsuit, Licensee may place all of the
royalties derived from sales of the PRODUCT in the country where such lawsuit is
pending in an interest-bearing escrow account. The escrow account shall be
established in a bank mutually acceptable to both parties under escrow
instructions insulating the funds from claims of any creditor. Upon termination
of the action, one-half (1/2) of any judgment amount, reasonable attorneys'
fees and costs, may be paid from this escrow account. Should the settlement of
any such patent infringement lawsuit involve payment of royalties by Licensee to
a third party for the continued right to manufacture, use, and sell the PRODUCT,
then funds in the escrow account and royalties payable to USC may be applied
against up to one-half (1/2) of such royalties to a third party. Any funds
thereafter remaining in the escrow shall be paid to USC. The above shall
constitute USC's sole liability and responsibility in the event of such action.
Royalties paid to third parties as provided for above shall be included when
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determining whether the minimum royalty provided for in this Agreement has been
paid in a given year. During the patent infringement litigation both parties
shall keep each other informed in writing of significant developments in the
lawsuit.
b. Offensive Controversy.
Licensee shall promptly notify USC of any potential infringement of a
PATENT. In the event that a third party infringes on a PATENT, Licensee shall
have the right but not an obligation to bring legal action to enforce any such
patent. If Licensee exercises such right, Licensee shall select legal counsel
and pay all legal fees and costs of prosecution of such action. In the event
that Licensee shall choose not to take such action, USC shall have the right, at
its option and at its own expense, to prosecute any action to enjoin such
infringement or to prosecute any claim for damages. The party prosecuting any
such action shall be entitled to retain any funds received as a result of
settlement or judgment of such action. The parties may also agree to jointly
pursue infringers. After deduction and payment to the parties of their
respective costs and fees (including without limitation reasonable attorneys'
fees) incurred in prosecuting any such actions, the net funds obtained as a
result of settlement or of judgment of any such jointly prosecuted action shall
be divided in the following manner: 25% of all net funds shall be divided
equally by the parties and 75% of all the net funds shall be divided between the
parties in the proportion to the amount of legal fees and costs incurred by the
parties in the prosecution of such actions. If funds are insufficient to pay all
costs and fees then all of the funds shall be paid to the parties in said
proportion.
c. During any litigation hereunder both parties shall keep each
other timely informed of any significant development in the litigation and
provide all reasonably requested technical assistance. During any said
controversy, full royalty payment shall continue, except as otherwise provided
herein.
8. RECORDS
Licensee and SUBLICENSEES shall keep complete, true and accurate books
of account and records for the purpose of showing the derivation of all amounts
payable to USC under this License Agreement. Said books and records shall be
kept at Licensee's principal place of business for at least four (4) years
following the end of the calendar year to which they pertain and shall be open
at all reasonable times for inspection upon prior written notice by a
representative of USC for the purpose of verifying Licensee's royalties
statement or Licensee's compliance in other respects with this License
Agreement. All information obtained as a result of such audit shall be
maintained in confidence, except that the representative may disclose to USC the
aggregate amount of royalties due to USC during each year, as determined in such
audit. Should an audit by USC show an underpayment of royalties by more than
10%, Licensee shall immediately pay such underpayment and all interest, as well
as for USC's reasonable audit expenses.
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9. SERVICES OF INVENTORS
USC shall make reasonable efforts to make Inventors available during
regular business hours to answer questions concerning certain technical aspects
of the technology. Should Licensee desire to use the services of Inventors for
further testing and/or market studies of the technology, a separate research and
development and/or consulting agreement should be negotiated with Inventors and
the USC Office of Contracts and Grants.
10. SUBLICENSE PERMISSION
Licensee may sublicense the PATENT(S) only upon giving USC advance
notice of the sublicense and providing a copy of the sublicense agreement. Each
SUBLICENSEE must agree in writing to be bound by the terms of this Agreement.
11. PATENT MARKING
Licensee shall use reasonable efforts to place all appropriate patent
and other intellectual property notices, markings and indicia on product and
marketing literature for the PRODUCTS as needed to protect the patent and other
intellectual property rights of USC and right for damages for infringement
thereof.
12. PUBLICATIONS
Nothing in this Agreement shall limit or prevent USC or Inventors from
publishing any information about the PATENT, except that USC and Inventors shall
furnish Licensee with a copy of any such public disclosure at least thirty (30)
days prior to the intended disclosure date. If the proposed publication contains
subject matter that Licensee would like to license, USC agrees to delay
publication up to an additional forty-five (45) days at the request of the
Licensee if patent protection is desired.
13. PUBLICITY
Neither party shall use the name, trade name, trademark or other
designation of the other party in connection with any products, promotion or
advertising without the prior written permission of the other party.
14. ASSIGNMENTS/TRANSFERS
Licensee may not assign or transfer this Agreement in whole or part to
any third party without the
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prior written permission of USC, which permission shall be granted in the sole
discretion of USC. The Licensee may only assign the entire Agreement to
successors of the entire business of the PRODUCTS if the successor agrees to be
bound by this Agreement and prior written notice is provided to USC.
15. TERMINATION
a. Upon the breach of or default under this License Agreement by
either party, the non-breaching party may terminate this License Agreement by
sixty (60) days written notice to the breaching party. Said notice shall be
effective at the end of such period unless during said period breaching party
shall remedy such defect or default. Licensee may also terminate this Agreement
at any time, for any reason, by providing USC a thirty (30) days written notice.
No license fees, or royalties shall be returnable. This Agreement may also be
terminated, subject to the Licensee's right to cure within ten (10) days, by USC
on the occurrence of any of the following: (i) Licensee attempts to use,
sublicense, transfer or assign its rights or obligations under this Agreement in
any manner contrary to the terms of this Agreement or in derogation of USC's
proprietary rights; (ii) Licensee fails to obtain and maintain the insurance
coverages required by Paragraph 23 hereof; or (iii) Licensee is determined to be
insolvent or makes an assignment for the benefit of creditors, or has a
bankruptcy petition filed by or against it, or a receiver or trustee in
bankruptcy or similar officer is appointed to take charge of all or part of
Licensee's property. Upon termination of the Agreement all rights granted to or
provided by each party to the other shall automatically and irrevocably revert
to the granting party.
b. Surviving any termination are:
i. Licensee's obligation to pay royalties accrued or
accruable.
ii. Licensee's obligation of Paragraph 8 to keep and
allow a final audit.
iii. Any cause of action or claim of Licensee or USC,
accrue or to accrue, because of any breach or default
by the other party.
iv. The provisions of Paragraphs 21,22 and 23.
c. Upon termination of this Agreement, Licensee agrees to
immediately discontinue the manufacture and sale of the PRODUCTS and the use of
the PATENTS. Within twenty (20) days after such termination, Licensee shall
provide USC with a written inventory of all PRODUCTS currently in its stock as
of the date of termination (the "INVENTORY"). USC shall have the option to grant
to Licensee the privilege of disposing of such INVENTORY at its normal prices
within three (3) months after said termination. Licensee shall dispose of this
INVENTORY only to customers who had previously purchased PRODUCTS from Licensee
during the term of this Agreement, and in no event shall Licensee sell such
INVENTORY to wholesalers, diverters, jobbers or any other entity which does not
sell at retail exclusively or to any one else who intends to sell such INVENTORY
at close-out. The disposition of all such INVENTORY, however, shall be subject
to all of the terms and conditions of this
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Agreement. After the three (3) month sell-off period, Licensee shall destroy or
return to USC at the election and cost of USC all remaining unsold PRODUCTS and
all packaging and marketing materials, and shall certify their destruction or
return to USC specifying the number of each destroyed or returned. All royalty
obligations, including any unpaid portions of the minimum royalty, shall be
accelerated and shall become immediately due and payable. In addition, Licensee
shall immediately deliver to USC or destroy all materials relating to the
PATENTS, together with all copies thereof, and deliver to USC all market studies
or other tests or studies conducted by Licensee with respect to the PRODUCTS,
all at no cost whatsoever to USC.
d. LICENSEE acknowledges and agrees that any violation of this
Agreement by Licensee would result in irreparable harm to USC. Accordingly,
Licensee consents and agrees that, if Licensee violates any of the provisions of
this Agreement, USC shall be entitled, in addition to other remedies available
to it, to an injunction to be issued by any court of competent jurisdiction
restraining Licensee from committing or continuing any violation of this
Agreement.
16. NOTICES, REPORTS AND PAYMENTS
Any notice, report or payment permitted or required under this
Agreement shall be in writing, and shall be sent by return receipt delivery or
delivered to the receiving party at the address set forth below or at such
address as either party may from time to time designate in writing.
USC: Office of Patent and Copyright Administration
University of Southern California
3716 South Hope Street, Suite 313
Los Angeles, California 90007-4344 (U.S.A.)
Attn: Director
LICENSEE: Bio-Management, Inc.
4 Hook Road
Sharon Hill, PA 19079
Attn: Joseph A. Troilo, Jr.
Corporate Counsel
17. PARAGRAPH HEADINGS
Paragraph headings are for the convenience of this Agreement only and
shall not add to or detract from any of the terms or provisions.
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18. SEVERABILITY
If any provision of this Agreement is held invalid under any law
applicable to the parties, SUBLICENSEES and/or assignees, that provision shall
be considered severable and its invalidity shall not affect the remainder of
this Agreement, which shall continue in full force and effect.
19. CONTROLLING LAW, JURISDICTION AND VENUE
This Agreement shall be deemed to be executed and to be performed in
the State of California, and shall be construed in accordance with the laws of
the State of California as to all matters, including but not limited to matters
of validity, construction, effect and performance. In the event of any
controversy, claim or dispute between the parties hereto arising out of or
relating to this agreement, such controversy, claim or dispute may be tried
exclusively in the courts of the State of California or in the United States
Federal District Court for the Central District of California, as either party
may elect. Each of the parties hereby waives any defense of lack of in personam
jurisdiction, improper venue and forum non conveniens, and agrees that service
of process of such court may be made upon each of them by personal delivery or
by mailing certified or registered mail, return receipt requested, to the other
party at the address provided for in Paragraph 16 hereof. Both parties hereby
submit to the jurisdiction of the court so selected, to the exclusion of any
other courts which may have had jurisdiction apart from this Paragraph 19.
20. TERM OF THE AGREEMENT
Except as otherwise terminated pursuant to the other provisions of this
License Agreement, this Agreement shall terminate upon expiration of the last to
expire of the patents or fifteen (15) years from the Effective Date of this
Agreement, whichever is longer.
21. NEGATION OF WARRANTIES
a. Nothing in this Agreement shall be construed as:
i. a warranty or representation by USC as to the
validity or scope of the PATENT and/or PATENT
Application; or
ii. a warranty or representation that any PRODUCTS made,
used, sold or otherwise disposed of under any license
granted in this Agreement is or will be free from
infringement of patents of third parties; or
iii. an obligation to bring or prosecute actions or suits
against third parties for infringement; or
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iv. conferring the rights to use in advertising,
publicity or otherwise any trademark, trade name, or
names or any contraction, abbreviation, simulation or
adoption thereof, of USC or Licensee; or
v. any obligation to furnish any know-how not provided.
b. USC MAKES NO EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY
OR FITNESS FOR A PARTICULAR PURPOSE, nor does USC represent that the rights
granted hereunder will result in PRODUCTS that are commercially successful.
c. Licensee further agrees that it will not rely upon technical
information provided by USC and Inventors in developing and manufacturing any
PRODUCTS hereunder, but will independently test, analyze and evaluate all
PRODUCTS prior to manufacture and distribution of such PRODUCTS.
22. INDEMNITY
a. Licensee shall defend, indemnify and hold harmless USC and its
trustees, officers, medical and professional staff, employees and agents and
their respective successors, heirs and assigns (the "Indemnitees"), against all
liabilities, demands, losses, costs, and expenses (including without limitation
attorneys' fees) incurred by or imposed upon the Indemnitees or any one of them
in connection with any claims, suits, actions, demands or judgments arising out
of any theory of liability (including but not limited to, actions in the form of
tort, warrantee, or strict liability) for death, personal injury, illness, or
property damage arising from Licensee's use, sale, or other disposition of the
PRODUCT(S).
b. Licensee agrees, at its own expense, to provide attorneys
reasonably acceptable to USC to defend against any actions brought or filed
against any party indemnified hereunder with respect to the subject of indemnity
contained herein, whether or not such actions are rightfully brought. To the
extent that any proposed settlement directly affects USC, the Licensee shall
obtain the approval of USC before finally agreeing to such settlement proposal,
which consent shall not be unreasonably withheld.
23. INSURANCE
a. Upon the execution of this Agreement Licensee shall at its
sole cost and expense, procure and maintain in effect a comprehensive general
liability policy of insurance in single limit coverage of not less than One
Million Dollars ($1,000,000) per incident and One Million Dollars ($1,000,000)
annual aggregate for death, bodily injury or illness and Two Hundred Thousand
Dollars ($200,000) annual aggregate in property damage. Such comprehensive
general liability insurance shall provide (i) product liability coverage and
(ii) broad form contractual liability coverage for Licensee's indemnification.
If Licensee elects to self-insure all or part of the limits described above
(including deductibles or retention which are in excess of $50,000 annual
aggregate) such self-insurance program must be acceptable to
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USC. Each such policy of insurance shall name USC as an additional insured and
shall provide for not less than thirty (30) days prior written notice before any
cancellation or material change in coverage shall be effective. A Certificate
evidencing the comprehensive general liability policy herein defined shall be
delivered to USC within ten (10) days of the EFFECTIVE DATE of this agreement.
Licensee shall maintain such comprehensive general liability insurance until
such time as the policy in Paragraph 23.b. or Paragraph 23.c is procured, or
until fifteen (15) years after the term of this Agreement.
b. During such time and in each country where PRODUCT, or any
modification thereof, is utilized in human clinical trials by Licensee or any
SUBLICENSEE, Licensee shall at its sole cost and expense, procure and maintain
in effect a comprehensive general liability policy of insurance in single limit
coverage of not less than Five Million Dollars ($5,000,000) per incident and
Five Million Dollars ($5,000,000) annual aggregate for death, bodily injury,
illness or property damage. Such comprehensive general liability insurance shall
provide (i) product liability coverage and (ii) broad form contractual liability
coverage for Licensee's indemnification. If Licensee elects to self-insure all
or part of the limits described above (including deductibles or retention which
are in excess of $125,000 annual aggregate) such self-insurance program must be
acceptable to USC. Each such policy of insurance shall name USC as an additional
insured and shall provide for not less than thirty (30) days prior written
notice before any cancellation or material change in coverage shall be
effective. A Certificate evidencing the comprehensive general liability policy
herein defined shall be delivered to USC prior to any manufacture, sale,
distribution or administration to humans. Licensee shall maintain such
comprehensive general liability insurance until such time as the policy in
Paragraph 23.c is procured, or until fifteen (15) years after the term of this
Agreement.
c. During such time and in each country where PRODUCT, or any
modification thereof, is administered to humans, manufactured or distributed for
any purpose other than for human clinical trials as specified in Paragraph 23.b
(including for the purpose of obtaining regulatory approvals) by Licensee or any
SUBLICENSEE, Licensee shall at its sole cost and expense, procure and maintain
in effect a comprehensive general liability policy of insurance in single limit
coverage of not less than Ten Million Dollars ($10,000,000) per incident and Ten
Million Dollars ($10,000,000) annual aggregate for death, bodily injury, illness
or property damage. Such comprehensive general liability insurance shall provide
(i) product liability coverage and (ii) broad form contractual liability
coverage for Licensee's indemnification. If Licensee elects to self-insure all
or part of the limits described above (including deductibles or retention which
are in excess of $250,000 annual aggregate) such self-insurance program must be
acceptable to USC. Each such policy of insurance shall name USC as an additional
insured and shall provide for not less than thirty (30) days prior written
notice before any cancellation or material change in coverage shall be
effective. A Certificate evidencing the comprehensive general liability policy
herein defined shall be delivered to USC prior to any manufacture, sale,
distribution or administration to humans. Licensee shall maintain such
comprehensive general liability insurance during the period that the PRODUCT or
any modification thereof is being manufactured, sold, distributed or
administered to humans by the Licensee or its SUBLICENSEES and a reasonable
period thereafter which in no event shall be less than fifteen (15) years.
d. In the event that Licensee does not maintain such insurance,
but is self-insured, or carries a
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substantial self-retention, USC may grant permission for such self-insurance
only if, in the sole discretion of USC, the net worth, assets and earnings of
the Licensee are deemed sufficient to protect USC's economic interests in the
event of claims, liability, demands, damages, expenses and losses from death,
personal injury, illness, or property damage.
e. The minimum amounts of insurance coverage required under this
Paragraph (subparts 23.a., 23.b., and 23.c.) shall not be construed to create a
limit of Licensee's liability with respect to its indemnification in Paragraph
22 or any other provision of this Agreement.
f. Licensee shall include in the terms of any sublicense
provisions obligating the sublicensee to indemnify Licensee and USC to the same
extent and degree as Licensee has agreed to indemnify USC herein and to procure
and maintain in effect, at all times during which the sublicensee manufactures,
uses, sells, leases, or otherwise transfers or disposes of PRODUCTS and for a
reasonable period of time thereafter but in any event not less than fifteen (15)
years, a comprehensive general liability policy of insurance having coverages no
less that those specified in Paragraphs 23.a., 23.b. and 23.c. herein naming
both Licensee and USC as additional insured. A Certificate evidencing the
comprehensive general liability policy shall be delivered to USC prior to USC's
giving permission for such sublicensing agreement and a Certificate evidencing
the product liability coverage shall be delivered prior to first manufacture of
any PRODUCTS by the SUBLICENSEE. In the event a prospective SUBLICENSEE does not
maintain such insurance, but is self-insured, or carries a substantial
self-retention, USC may grant permission for such sublicense only if, in the
sole discretion of USC, the net worth, assets and earnings of such prospective
SUBLICENSEE are deemed sufficient to protect USC's economic interests in the
event of claims, liability, demands, damages, expenses and losses from death,
personal injury, illness, or property damage.
24. ATTORNEYS' FEES
In any action on or concerning this Agreement, the prevailing party
shall be awarded its reasonable attorneys' fees, costs and necessary
disbursements, to be paid by the nonprevailing party.
25. PRODUCT DEVELOPMENT
Licensee shall use its reasonable efforts to test, develop the PRODUCT
for commercial purposes throughout the world. On or before January 1 of each
year during the term of this Agreement, commencing January 1,2003, Licensee
shall submit to USC a report detailing its research, regulatory approval,
marketing and product development objectives the coming year as well as the
research, regulatory approval, marketing and development activities which
Licensee undertook during the preceding year. The reports shall identify
specific future milestones (regulatory approval and product development) and
information demonstrating that the Licensee is providing sufficient financial
and manpower resources to evidence its use of reasonable efforts. Within six (6)
months after the signing of
13
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this Agreement and each two (2) years thereafter, a representative of the Office
of Patent and Copyright Administration of USC, at Licensee's expense (including
transportation, and, if appropriate, lodging and meals), shall visit the
manufacturing and marketing facilities of Licensee and be presented with an
in-depth updating of the manufacturing capability and marketing network of
Licensee.
26. CONFIDENTIAL INFORMATION
a. Neither party shall, without the prior written consent of the
other party in each instance, disclose or use in any way, except as is
consistent with the terms of this Agreement, any Confidential Information of the
other party acquired in the course of the transactions contemplated hereby.
b. Confidential Information shall mean any business or technical
information disclosed by one of the parties to this Agreement to the other
party, and prominently stamped as "CONFIDENTIAL", whether or not patentable,
copyrightable or otherwise protected by law; excluding information:
i. that was in the public domain at the time the
disclosing party communicated such Confidential Information;
ii. that was in the public domain through no fault of the
party receiving the disclosure; or
iii. which the party receiving the disclosure can show
conclusively, by written records kept in the ordinary course of its business or
by proof of actual use to have been (i) in its possession or (ii) independently
developed without reliance on Confidential Information.
c. Notwithstanding, all correspondence regarding PATENTS to or
from USC's patent counsel or a government patent office or tribunal shall be
considered Confidential Information, regardless of whether such information is
stamped as confidential, provided none of the above exceptions apply.
27. EXPORT CONTROLS
It is understood that USC is subject to United States laws and
regulations controlling the export of technical data, computer software,
laboratory prototypes and other commodities (such laws include the Arms Export
Control Act, as amended and the Export Administration Act), and that its
obligations hereunder are contingent on compliance with applicable United States
export laws and regulations. The transfer of certain technical data and
commodities by the Licensee may require a license from the cognizant agency of
the United States Government and/or written assurances by Licensee that Licensee
shall not export data or commodities to certain foreign countries without prior
approval of such agency. USC neither represents that a license shall not be
required nor that, if required, it shall be issued. Licensee shall not engage in
any activity in connection with this Agreement that is in violation of any
applicable U.S. law.
14
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28. INDEPENDENT CONTRACTOR
In rendering performances under this Agreement, Licensee will function
solely as an independent contractor and not as agent, partner, employee or joint
venturer with USC. Nothing in this Agreement shall be deemed or construed to
create the relationship of principal and agent, or of partnership or joint
venture, and neither party shall hold itself out as an agent, legal
representative, partner, subsidiary, joint venturer, servant or employee of the
other. Neither party nor any officer, employee, agent or representative thereof
shall, in any event, have any right, collectively or individually, to bind the
other party, to make any representations or warranties, to accept service of
process, to receive notice or to perform any act or thing on behalf of the other
party, except as expressly authorized under this Agreement or in writing by such
other party in its sole discretion.
29. WAIVER
No waiver by either party of any default or breach shall be deemed as a
waiver of prior or subsequent default or breach of the same or other provisions
of this Agreement.
30. ENTIRE AGREEMENT
This Agreement constitutes the entire agreement between the parties
concerning the subject matter hereof. No amendment, modification, extension or
cancellation of this Agreement shall be binding on the parties unless mutually
agreed to and executed in writing by each of the parties.
UNIVERSITY OF SOUTHERN CALIFORNIA BIO-MANAGEMENT INC.
/s/ Dennis F. Dougherty /s/ Raymond A. Mirra, Jr.
---------------------------------------- --------------------------------
(Signature) (Signature)
Dennis F. Dougherty Raymond A. Mirra, Jr.
---------------------------------------- --------------------------------
(Print or Type Name) (Print or Type Name)
Senior Vice President for Administration Chairman
---------------------------------------- --------------------------------
(Official Title) (Official Title)
5/23/00 5/8/2000
---------------------------------------- --------------------------------
(Date) (Date)
15
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APPENDIX A
<TABLE>
<CAPTION>
FILING
USC NO. SERIAL NO. DATE COUNTRY TITLE
-----------------------------------------------------------------------------------------------------
<S> <C> <C> <C> <C>
3004 N/A Not yet filed Identification of a Fragment of a
Metalloproteinase That Potentially Inhibits
Angiogenesis and Tumor Growth in Vivo
3021 N/A Not yet filed Identification of a Fragment of a
Metalloproteinase That Stimulates Tumor
Growth in Vivo
</TABLE>