License Agreement - Scripps Research Institute and Cell Matrix Inc.
LICENSE AGREEMENT
BY AND BETWEEN
THE SCRIPPS RESEARCH INSTITUTE,
A CALIFORNIA NONPROFIT
PUBLIC BENEFIT CORPORATION
AND
CELL MATRIX INC.,
A NEVADA CORPORATION
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TABLE OF CONTENTS
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1. Definitions.............................................................................................. -2-
1.1 Affiliate................................................................................................ -2-
1.2 Agricultural Products ................................................................................. -2-
1.3 Confidential Information................................................................................. -2-
1.4 Field.................................................................................................... -2-
1.5 Licensed Product......................................................................................... -2-
1.6 Major Market Country .................................................................................. -3-
1.7 Net Sales................................................................................................ -3-
1.8 Scripps Technology .................................................................................... -3-
1.9 Scripps Patent Rights ................................................................................. -3-
2. License Terms and Conditions........................................................................... -3-
2.1 Grant of License......................................................................................... -3-
2.2 Initial License Fee .................................................................................... -3-
2.4 Royalties................................................................................................ -4-
2.4.1 Percentage Royalty............................................................................ -4-
2.4.2 Minimum Royalty............................................................................... -5-
2.5 Quarterly Payments....................................................................................... -5-
2.6 Term of License.......................................................................................... -5-
2.7 Sublicense ............................................................................................ -5-
2.8 Duration of Royalty Obligations ....................................................................... -6-
2.9 Reports.................................................................................................. -6-
2.10 Records.................................................................................................. -6-
2.11 Foreign Sales............................................................................................ -7-
2.12 Foreign Taxes............................................................................................ -7-
3. Patent Matters......................................................................................... -7-
3.1 Patent Prosecution and Maintenance....................................................................... -7-
3.2 Information to Licensee.................................................................................. -7-
3.3 Patent Costs ........................................................................................... -8-
3.4 Ownership................................................................................................ -8-
3.5 Scripps Right to Pursue Patent........................................................................... -8-
3.6 Infringement Actions .................................................................................. -8-
3.6.1 Prosecution and Defense of Infringements................................................................. -8-
3.6.2 Allocation of Recovery................................................................................... -9-
4. Obligations Related to Commercialization............................................................... -9-
4.1 Commercial Development Obligation........................................................................ -9-
4.2 Governmental Approvals and Marketing of Licensed Products ............................................. -9-
4.3 Indemnity................................................................................................ -9-
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4.4 Patent Marking........................................................................... -10-
4.5 No Use of Name........................................................................... -10-
4.6 U.S. Manufacture......................................................................... -10-
4.7 Foreign Registration..................................................................... -10-
5. Limited Warranty....................................................................... -10-
6. Interests in Intellectual Property Rights ........................................... -10-
6.1 Preservation of Title.................................................................... -10-
6.2 Royalty-free License to Improvements..................................................... -11-
6.3 Governmental Interest.................................................................... -11-
6.4 Reservation of Rights.................................................................... -11-
7. Confidentiality and Publication........................................................ -11-
7.1 Treatment of Confidential Information.................................................... -11-
7.2 Publications............................................................................. -11-
7.3 Publicity................................................................................ -11-
8. Term and Termination................................................................... -12-
8.1 Term..................................................................................... -12-
8.2 Termination Upon Default................................................................. -12-
8.3 Termination Upon Bankruptcy or Insolvency................................................ -12-
8.4 Rights Upon Expiration................................................................... -12-
8.5 Rights Upon Termination.................................................................. -12-
8.6 Work-in-Progress......................................................................... -13-
9. Assignment; Successors................................................................. -13-
9.1 Assignment............................................................................... -13-
9.2 Binding Upon Successors and Assigns...................................................... -13-
10. General Provisions..................................................................... -13-
10.1 Independent Contractors.................................................................. -13-
10.2 Arbitration ............................................................................ -13-
10.2.1 Location................................................................................. -14-
10.2.2 Selection of Arbitrators................................................................. -14-
10.2.3 Discovery................................................................................ -14-
10.2.4 Case Management.......................................................................... -14-
10.2.5 Remedies................................................................................. -14-
10.2.6 Expenses................................................................................. -14-
10.2.7 Confidentiality.......................................................................... -15-
10.3 Entire Agreement; Modification........................................................... -15-
10.4 California Law........................................................................... -15-
10.5 Headings................................................................................. -15-
10.6 Severability............................................................................. -15-
10.7 No Waiver .............................................................................. -15-
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10.8 Name .................................................................................... -16-
10.9 Attorneys' Fees ......................................................................... -16-
10.10 Notices................................................................................. -16-
10.11 Compliance with U.S. Laws .............................................................. -16-
Exhibit A Scripps Technology
Exhibit B Form of Sublicense
Exhibit C Developmental Milestones
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LICENSE AGREEMENT
This License Agreement is entered into and made effective as
of this________________ day of___________________________, 2001, by and between
THE SCRIPPS RESEARCH INSTITUTE, a California nonprofit public benefit
corporation ("Scripps") located at 10550 North Torrey Pines Road, La Jolla,
California 92037, and CELL MATRIX, a Nevada corporation ("Licensee") with
administrative offices located at 4 Hook Road, Sharon Hill, Pennsylvania, with
respect to the facts set forth below.
RECITALS
A. Scripps is engaged in fundamental scientific
biomedical and biochemical research including research relating to angiogenesis.
B. Licensee is engaged in research and development of
biotechnology and pharmaceutical products which regulate the growth of new blood
vessels.
C. Scripps has disclosed to Licensee certain technology
described in [***] copies of which are attached hereto as Exhibit A and
incorporated herein by reference (the "Applications").
D. Scripps has the exclusive right to grant a license to
the technology described in the Applications, subject to certain rights of the
U.S. Government to use such technology for its own purposes, resulting from the
receipt by Scripps of certain funding from the U.S. Government.
E. Scripps desires to grant to Licensee, and Licensee
wishes to acquire, an exclusive worldwide right and license to the technology
described in the Applications and to certain patent rights and know-how of
Scripps with respect thereto, subject to the terms and conditions set forth
herein, with a view to developing and marketing diagnostic and/or therapeutic
products within the Field (as defined below).
AGREEMENT
NOW, THEREFORE, in consideration of the mutual covenants and
conditions set forth herein, Scripps and Licensee hereby agree as follows:
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1. Definitions. Capitalized terms shall have
the meaning set forth below.
1.1 Affiliate. The term "Affiliate" shall mean any
entity which directly or indirectly controls, is controlled by or is under
common control with Licensee. The term "control" as used herein means the
possession of the power to direct or cause the direction of the management and
the policies of an entity, whether through the ownership of a majority of the
outstanding voting securities or by contract or otherwise.
1.2 Agricultural Products. The term "Agricultural
Product", individually, or "Agricultural Products", collectively, shall mean any
one or more product, device, method, procedure, software, computer program,
material, or element utilized by the agricultural and farming industry for the
purpose of improving, restricting or otherwise modifying growth or productivity
of plants; or preventing or treating disease or insect or fungal infestation in
plants; or controlling or modifying certain traits of plants or producing
improved or modified seeds and plants; or techniques and methods for evaluating
efficacy or determining the safety of an Agricultural Product such as
utilization in determining toxicity to living things or otherwise involved in
the general field of agriculture.
1.3 Confidential Information. The term "Confidential
Information" shall mean any and all proprietary or confidential information of
Scripps or Licensee which may be exchanged between the parties at any time and
from time to time during the term of this Agreement. Information shall not be
considered confidential to the extent that it:
a. Is publicly disclosed through no
fault of any party hereto, either before or after it becomes known to the
receiving party; or
b. Was known to the receiving party
prior to the date of this Agreement, which knowledge was acquired independently
and not from another party hereto (or such party's employees); or
c. Is subsequently disclosed to the
receiving party in good faith by a third party who has a right to make such
disclosure; or
d. Has been published by a third party
as a matter of right.
1.4 Field. The term "Field" shall mean human
therapeutic and diagnostic applications and shall specifically exclude any
Agricultural Product.
1.5 Licensed Product. The term "Licensed Product"
shall mean any product which cannot be developed, manufactured, offered to sale,
used or sold without (i) infringing one or more claims under Scripps Patent
Rights or (ii) utilizing any part of Scripps Technology not otherwise
includable within Scripps Patent Rights.
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1.6 Major Market Country. The term "Major Market
Country" shall mean any of the following countries and their respective
territories and possessions: Canada, France, Germany, Italy, Japan, the United
Kingdom and the United States.
1.7 Net Sales. The term "Net Sales" shall mean the
gross amount received by Licensee upon payment of invoice, or its Affiliates and
sublicensees, or any of them, on all sales of Licensed Products, less (i)
discounts actually allowed, (ii) credits for claims, allowances, retroactive
price reductions or returned goods, (iii) prepaid freight and (iv) sales taxes
or other governmental charges actually paid in connection with sales of Licensed
Products (but excluding what are commonly known as income taxes and value-added
taxes). For purposes of determining Net Sales, a sale shall be deemed to have
occurred when an invoice therefor shall be generated and payment received by
Licensee, or its Affiliates and Sublicensees or any of them. Sales of Licensed
Products by Licensee, or an Affiliate or sublicensee of Licensee to any
Affiliate or sublicensee which is a reseller thereof shall be excluded, and only
the subsequent sale of such Licensed Products by Affiliates or sublicensees of
Licensee to unrelated parties shall be deemed Net Sales hereunder.
1.8 Scripps Patent Rights. The term "Scripps Patent
Rights" shall mean rights arising out of or resulting from (i) any and all U.S.
and foreign patent applications and patents covering Scripps Technology, (ii)
the patents proceeding from such applications, (iii) all claims of
continuations-in-part directed solely to subject matter specifically described
in Scripps Technology, and (iv) divisionals, continuations, reissues,
reexaminations, and extensions of any patent or application set forth in
(i)-(iii) above, so long as said patents have not been held invalid and/or
unenforceable by a court of competent jurisdiction from which there is no appeal
or, if appealable, from which no appeal has been taken.
1.9 Scripps Technology. The term "Scripps Technology"
shall mean so much of the technology as is proprietary to Scripps disclosed in
the Applications a copy of which is attached as Exhibit A hereto and
incorporated herein by reference, together with materials, information and
know-how related thereto whether or not the same is eligible for protection
under the patent laws of the United States or elsewhere, and whether or not any
such processes and technology, or information related thereto, would be
enforceable as a trade secret or the copying of which would be enjoined or
restrained by a court as constituting unfair competition.
2. License Terms and Conditions.
2.1 Grant of License. Scripps hereby grants to
Licensee an exclusive, worldwide license, including the right to sublicense, to
Scripps Technology and under Scripps Patent Rights, to make, to have made, to
import, to use, to offer for sale, and to sell Licensed Products in the Field,
subject to the terms of this Agreement.
2.2 Initial License Fee. In partial consideration for
the exclusive license granted pursuant to Section 2.1 hereof, Licensee shall pay
to Scripps a nonrefundable license fee upon execution of this Agreement in the
amount of fifty thousand Dollars ($50,000). The
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license fee described in this Section is consideration for the grant and
continuation of the license hereunder, and Scripps shall have no obligation to
return any portion of such license fee, notwithstanding any failure by Licensee
to develop any Licensed Product or market any Licensed Product commercially, and
notwithstanding the volume of sales of any such Licensed Product.
2.3 Milestones. In consideration for the License
granted to Licensee, Licensee shall pay the milestone payment to Scripps upon
the first occurrence of each event specified below in a Major Market Country for
the first Licensed Product to meet such milestone. Payment of the milestones
shall be due within thirty (30) days of achievement of the event.
Event for a therapeutic Licensed Product or its equivalent in a Major Market
Country
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Milestone Payment
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IND filing [***]
Completion of Phase I [***]
Completion of Phase II [***]
Completion of Phase III [***]
Receipt of Market Approval [***]
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Event for a diagnostic Licensed Product or its equivalent in a Major Market
Country
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Milestone Payment
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IND filing [***]
Completion of Phase I [***]
Completion of Phase II [***]
Completion of Phase III [***]
510 K filing [***]
Receipt of Market Approval [***]
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omitted portions.
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2.4 Royalties
2.4.1 Percentage Royalty. As additional
consideration for the exclusive license granted pursuant to Section 2.1 hereof,
Licensee shall pay to Scripps a continuing royalty on a country-by-country basis
in the amount of (i) [***] of Net Sales of therapeutic Licensed Products which
cannot be made, used or sold in such country without utilizing one or more valid
claims under Scripps Patent Rights, (ii) [***] of Net Sales of diagnostic
Licensed Products which cannot be made, used or sold in such country without
utilizing one or more valid claims under Scripps Patent Rights, and (iii) [***]
of Net Sales of all other Licensed Products.
2.4.2 Minimum Royalty. Beginning on the
third anniversary of this Agreement, in order to maintain the license granted
hereunder in force, Licensee shall pay to Scripps a minimum annual royalty. The
minimum annual royalty for the twelve (12) month period beginning with such date
shall be ten thousand Dollars ($10,000), and the amount of the minimum annual
royalty payable for each subsequent twelve (12) month period during the term
hereof shall be the greater of ten thousand Dollars ($10,000) or the total
royalties payable under this Agreement during the immediately preceding twelve
(12) month period. Any percentage royalties earned and paid to Scripps pursuant
to Section 2.4.1 hereof for any twelve (12) month period shall be credited
against the minimum royalty payable for such period, and the payment of any
shortfall between actual royalties paid and the minimum annual royalty
applicable to such twelve (12) month period shall be payable to Scripps within
sixty (60) days after the last day of such twelve (12) month period.
2.5 Quarterly Payments.
2.5.1 Sales by Licensee. With regard to Net
Sales made by Licensee or its Affiliates, royalties shall be payable by Licensee
quarterly, within sixty (60) days after the end of each calendar quarter, based
upon the Net Sales of Licensed Products during such preceding calendar quarter,
commencing with the calendar quarter in which the first commercial sale of any
Licensed Product is made.
2.5.2 Sales by Sublicensees. With regard to
Net Sales made by sublicensees of Licensee or its Affiliates, royalties shall be
payable by Licensee quarterly, within ninety (90) days after the end of each
calendar quarter, based upon the Net Sales of Licensed Products by such
sublicensee during such preceding calendar quarter, commencing with the calendar
quarter in which the first commercial sale of any Licensed Product is made by
such sublicensee.
2.6 Term of License. Unless terminated sooner in
accordance with the provisions of this Agreement, the term of this license shall
expire when the last of the royalty obligations set forth has expired.
Notwithstanding the foregoing, if applicable government regulations require a
shorter term and/or a shorter term of exclusivity than provided for herein, then
the term of this License Agreement shall be so shortened or this License
Agreement shall
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be amended to provide for a non-exclusive license, and, in such event, the
parties shall negotiate in good faith to reduce appropriately the royalties
payable as set forth under the section heading "Royalties" hereof.
2.7 Sublicense. Licensee shall have the sole and
exclusive right to grant sublicenses to any party with respect to the rights
conferred upon Licensee under this Agreement, provided, however, that (i) any
such sublicense shall be subject in all respects to the restrictions,
exceptions, royalty obligations, reports, termination provisions, and other
provisions contained in this Agreement (but not including the payment of a
license fee pursuant to Section 2.2 hereof) and (ii) each such sublicensee, and
the form and substance of each such sublicense, shall be subject to the prior
written approval of Scripps, which approval shall not be unreasonably withheld,
provided, however, that any sublicense granted to an Affiliate of Licensee shall
not be subject to Scripps' prior written approval. No approval shall be required
as to any sublicense which utilizes the form of sublicense attached hereto as
Exhibit B. Licensee shall pay Scripps, or cause its Affiliate or sublicensee to
pay Scripps, the same royalties on all Net Sales of such Affiliate or
sublicensee the same as if said Net Sales had been made by Licensee. Each
Affiliate and sublicensee shall report its Net Sales to Scripps through
Licensee, which Net Sales shall be aggregated with any Net Sales of Licensee for
purposes of determining the Net Sales upon which royalties are to be paid to
Scripps.
Except as set forth below, any revenues, other than royalties,
due Licensee pursuant to the grant of a sublicense to a party not an Affiliate
shall be reported to Scripps by Licensee. Licensee shall pay to Scripps[***] of
any such revenue.
2.8 Duration of Royalty Obligations. The royalty
obligations of Licensee as to each Licensed Product shall terminate on a
country-by-country basis concurrently with the expiration of the last to expire
of Scripps Patent Rights utilized by or in such Licensed Product in each such
country or, with respect to Licensed Products not utilizing any Scripps Patent
Rights, fifteen (15) years after the date of first commercial sale of such
Licensed Product in such country.
2.9 Reports. Licensee shall furnish to Scripps at the
same time as each royalty payment is made by Licensee, a detailed written report
of Net Sales of the Licensed Products and the royalty due and payable thereon,
including a description of any offsets or credits deducted therefrom, on a
product-by-product and country-by-country basis, for the calendar quarter upon
which the royalty payment is based.
2. 10 Records. Licensee shall keep, and cause its
Affiliates and sublicensees to keep, full, complete and proper records and
accounts of all sales of Licensed Products in sufficient detail to enable the
royalties payable on Net Sales of each Licensed Product to be determined.
Scripps shall have the right to appoint an independent certified public
accounting firm approved by Licensee, which approval shall not be unreasonably
withheld, to audit the records of Licensee, its Affiliates and sublicensees as
necessary to verify the royalties payable pursuant to this Agreement. Any
auditing firm appointed by Scripps shall execute a confidentiality agreement
with Licensee prior to performing such audit. Licensee, its
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Affiliates and sublicensees shall pay to Scripps an amount equal to any
additional royalties to which Scripps is entitled as disclosed by the audit,
plus interest thereon at the rate of one and one-half percent (1.5%) per month.
Such audit shall be at Scripps' expense; provided, however, that if the audit
discloses that Scripps was underpaid royalties with respect to any Licensed
Product by at least five percent (5%) for any calendar quarter, then Licensee,
its Affiliates or sublicensee, as die case may be shall reimburse Scripps for
any such audit costs. Scripps may exercise its right of audit as to each of
Licensee, its Affiliates or sublicensees no more frequently than once in any
calendar year. The accounting firm shall disclose to Scripps only information
relating to the accuracy of the royalty payments. Licensee, its Affiliates and
sublicensees shall preserve and maintain all such records required for audit for
a period of three (3) years after the calendar quarter to which the record
applies.
2.11 Foreign Sales. The remittance of royalties
payable on sales outside the United States shall be payable to Scripps in United
States Dollar equivalents at the official rate of exchange of the currency of
the country from which the royalties are payable, as quoted in the Wall Street
Journal for the last business day of the calendar quarter in which the royalties
are payable. If the transfer of or the conversion into the United States Dollar
equivalents of any such remittance in any such instance is not lawful or
possible, the payment of such part of the royalties as is necessary shall be
made by the deposit thereof, in the currency of the country where the sale was
made on which the royalty was based to the credit and account of Scripps or its
nominee in any commercial bank or trust company of Scripps' choice located in
that country, prompt written notice of which shall be given by Licensee to
Scripps.
2.12 Foreign Taxes. Any tax required to be withheld
by Licensee under the laws of any foreign country for the accounts of Scripps
shall be promptly paid by Licensee for and on behalf of Scripps to the
appropriate governmental authority, and Licensee shall use its best efforts to
furnish Scripps with proof of payment of such tax together with official or
other appropriate evidence issued by the applicable government authority. Any
such tax actually paid on Scripps' behalf shall be deducted from royalty
payments due Scripps.
3. Patent Matters.
3.1 Patent Prosecution and Maintenance. From and
after the date of this Agreement, the provisions of this Section 3 shall control
the prosecution and maintenance of any patent included within Scripps Patent
Rights. Subject to the requirements, limitations and conditions set forth in
this Agreement, Scripps shall direct and control (i) the preparation, filing and
prosecution of the United States and foreign patent applications within Scripps
Patent Rights (including any interferences and foreign oppositions) and (ii)
maintain the patents issuing therefrom. Scripps shall select the patent
attorney, subject to Licensee's written approval, which approval shall not be
unreasonably withheld. Licensee shall have full rights of consultation with the
patent attorney so selected on all matters relating to Scripps Patent Rights.
Scripps shall use its best efforts to implement all reasonable requests made by
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Licensee with regard to the preparation, filing, prosecution and/or maintenance
of the patent applications and/or patents within Scripps Patent Rights.
3.2 Information to Licensee. Scripps shall keep
Licensee informed with regard to the patent application and maintenance
processes. Scripps shall deliver to Licensee copies of all patent applications,
amendments, related correspondence, and other related matters.
3.3 Patent Costs. Licensee acknowledges and agrees
that Scripps does not have independent funding to cover patent costs, and that
the license granted hereunder is in part in consideration for Licensee's
assumption of patent costs and expenses as described herein. Licensee shall pay
for all patent expenses incurred by Scripps pursuant to Section 3.1 hereof.
Licensee agrees to pay all such past and future patent expenses directly or to
reimburse Scripps for the payment of such expenses within sixty (60) days after
Licensee receives an itemized invoice therefor. In the event Licensee elects to
discontinue payment for the filing, prosecution and/or maintenance of any patent
application and/or patent within Scripps Patent Rights, any such patent
application or patent shall be excluded from the definition of Scripps Patent
Rights and from the scope of the license granted under this Agreement, and all
rights relating thereto shall revert to Scripps and may be freely licensed by
Scripps. Licensee shall give Scripps at least sixty (60) days' prior written
notice of such election. No such notice shall have any effect on Licensee's
obligations to pay expenses incurred up to the effective date of such election.
3.4 Ownership. The patent applications filed and the
patents obtained by Scripps pursuant to Section 3.1 hereof shall be owned solely
by Scripps, assigned to Scripps and deemed a part of Scripps Patent Rights.
3.5 Scripps Right to Pursue Patent. If at any time
during the term of this Agreement, Licensee's rights with respect to Scripps
Patent Rights are terminated, Scripps shall have the right to take whatever
action Scripps deems appropriate to obtain or maintain the corresponding patent
protection at its own expense. If Scripps pursues patents under this Section
3.5, Licensee agrees to cooperate fully, including by providing, at no charge to
Scripps, all appropriate technical data and executing all necessary legal
documents.
3.6 Infringement Actions.
3.6.1 Prosecution and Defense of
Infringements. In order to maintain the license granted hereunder in force,
Licensee shall prosecute any and all infringements of any Scripps Patent Rights
and shall defend all charges of infringement arising as a result of the exercise
of Scripps Patent Rights by Licensee, its Affiliates or sublicensees, unless
otherwise agreed to between Scripps and Licensee. Licensee may enter into
settlements, stipulated judgments or other arrangements respecting such
infringement, at its own expense, but only with the prior written consent of
Scripps, which consent shall not be unreasonably withheld. Scripps shall permit
any action to be brought in its name if required by law, and Licensee shall hold
Scripps harmless from any costs, expenses or liability respecting all such
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infringements or charges of infringement. Scripps agrees to provide reasonable
assistance of a technical nature which Licensee may require in any litigation
arising in accordance with the provisions of this Section 3.6.1, for which
Licensee shall pay to Scripps a reasonable hourly rate of compensation. In the
event Licensee fails to prosecute any such infringement, Licensee shall notify
Scripps in writing promptly and Scripps shall have the right to prosecute such
infringement on its own behalf. Failure on the part of Licensee to prosecute any
such infringement shall be grounds for termination of the license granted to
Licensee hereunder, with respect to the country in which such infringement
occurs, at the option of Scripps.
3.6.2 Allocation of Recovery. Any damages or
other recovery from an infringement action undertaken by Licensee pursuant to
Section 3.6.1 shall first be used to reimburse the parties for the costs and
expenses incurred in such action, and shall thereafter be allocated between the
parties as follows: (i) thirty percent (30%) to Scripps and (ii) seventy percent
(70%) to Licensee. If Licensee fails to prosecute any such action to completion,
then any damages or other recovery net of the parties' costs and expenses
incurred in such infringement action shall be the sole property of Scripps.
4. Obligations Related to Commercialization.
4. 1 Commercial Development Obligation. In order to
maintain the license granted hereunder in force, Licensee shall use reasonable
efforts and due diligence to develop Scripps Technology and Scripps Patent
Rights which are licensed hereunder into commercially viable Licensed Products,
as promptly as is reasonably and commercially feasible, and thereafter to
produce and sell reasonable quantities of Licensed Products. Licensee shall keep
Scripps generally informed as to Licensee's progress in such development,
production and sale, including its efforts, if any, to sublicense Scripps
Technology and Scripps Patent Rights, and Licensee shall deliver to Scripps a
progress report (a) every six months for the first two years following the
Effective Date and (b) thereafter an annual written report and such other
reports as Scripps may reasonably request. The parties hereto acknowledge and
agree that achievement of the milestones described in Exhibit C attached hereto
on or before the dates set forth therein shall be evidence of compliance by
Licensee with its commercial development obligations hereunder for the time
periods specified in Exhibit C. In the event Scripps has a reasonable basis to
believe that Licensee is not using reasonable efforts and due diligence as
required hereunder, upon notice by Scripps to Licensee which specifies the basis
for such belief, Scripps and Licensee shall negotiate in good faith to attempt
to mutually resolve the issue. In the event Scripps and Licensee cannot agree
upon any matter related to Licensee's commercial development obligations, the
parties agree to utilize arbitration pursuant to Section 10.2 hereof in order to
resolve the matter. If the arbitrator determines that Licensee has not complied
with its obligations hereunder, and such default is not fully cured within sixty
(60) days after the arbitrator's decision, Scripps may terminate Licensee's
rights under this Agreement.
4.2 Governmental Approvals and Marketing of Licensed
Products. Licensee shall be responsible for obtaining all necessary governmental
approvals for the
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development, production, distribution, sale and use of any Licensed Product, at
Licensee's expense, including, without limitation, any safety studies. Licensee
shall have sole responsibility for any warning labels, packaging and
instructions as to the use of Licensed Products and for the quality control for
any Licensed Product.
4.3 Indemnity. Licensee hereby agrees to indemnify,
defend and hold harmless Scripps and any and all co-owners of Scripps Technology
or Scripps Patent Rights, and any parent, subsidiary or other affiliated entity
and their trustees, officers, employees, scientists and agents from and against
any liability or expense arising from any product liability claim asserted by
any party as to any Licensed Product or any claims arising from the use of any
Scripps Patent Rights or Scripps Technology pursuant to this Agreement. Such
indemnity and defense obligation shall apply to any product liability or other
claims, including without limitation, personal injury, death or property damage,
made by employees, subcontractors, sublicensees, or agents of Licensee, as well
as any member of the general public. Licensee shall use its best efforts to have
Scripps, and any and all co-owners of Scripps Technology or Scripps Patent
Rights, and any parent, subsidiary or other affiliated entity and their
trustees, officers, employees, scientists and agents named as additional insured
parties on any product liability insurance policies maintained by Licensee, its
Affiliates and sublicensees applicable to Licensed Products.
4.4 Patent Marking. To the extent required by
applicable law, Licensee shall mark all Licensed Products or their containers in
accordance with the applicable patent marking laws.
4.5 No Use of Name. The use of the name "The Scripps
Research Institute", "Scripps", or any variation thereof in connection with the
advertising or sale of Licensed Products is expressly prohibited.
4.6 U.S. Manufacture. To the extent required by
applicable United States laws, Licensee agrees that Licensed Products will be
manufactured in the United States, or its territories, subject to such waivers
as may be required, or obtained, if at all, from the United States Department of
Health and Human Services, or its designee.
4.7 Foreign Registration. Licensee agrees to register
this Agreement with any foreign governmental agency which requires such
registration, and Licensee shall pay all costs and legal fees in connection
therewith. In addition, Licensee shall assure that all foreign laws affecting
this Agreement or the sale of Licensed Products are fully satisfied.
5. Limited Warranty. Scripps hereby represents
and warrants that it has full right and power to enter into this Agreement.
SCRIPPS AND ANY AND ALL CO- OWNERS OF SCRIPPS TECHNOLOGY OR SCRIPPS PATENT
RIGHTS MAKES NO OTHER WARRANTIES CONCERNING SCRIPPS PATENT RIGHTS OR SCRIPPS
TECHNOLOGY COVERED BY THIS AGREEMENT, INCLUDING WITHOUT LIMITATION, ANY EXPRESS
OR IMPLIED WARRANTY OF MERCHANTABILITY OR
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FITNESS FOR A PARTICULAR PURPOSE AS TO SCRIPPS PATENT RIGHTS, SCRIPPS TECHNOLOGY
OR ANY LICENSED PRODUCT. SCRIPPS AND ANY AND ALL CO-OWNERS OF SCRIPPS TECHNOLOGY
OR SCRIPPS PATENT RIGHTS MAKES NO WARRANTY OR REPRESENTATION AS TO THE VALIDITY
OR SCOPE OF SCRIPPS PATENT RIGHTS, OR THAT ANY LICENSED PRODUCT WILL BE FREE
FROM AN INFRINGEMENT ON PATENTS OR OTHER INTELLECTUAL PROPERTY RIGHTS OF THIRD
PARTIES, OR THAT NO THIRD PARTIES ARE IN ANY WAY INFRINGING SCRIPPS PATENT
RIGHTS OR SCRIPPS TECHNOLOGY COVERED BY THIS AGREEMENT.
6. Interests in Intellectual Property Rights.
6.1 Preservation of Title. Scripps and any and all
co-owners of Scripps Technology or Scripps Patent Rights shall retain full
ownership and title to Scripps Technology, and Scripps Patent Rights licensed
hereunder and shall use its reasonable best efforts to preserve and maintain
such full ownership and title, subject to Licensee fully performing all of its
obligations under this Agreement.
6.2 Royalty-free License to Improvements. Licensee
hereby grants to Scripps a non-exclusive, royalty-free license to any
improvement to Scripps Technology developed by Licensee, to use for its own
non-commercial research purposes or grant to other nonprofit institutions for
their non-commercial research purposes.
6.3 Governmental Interest. Licensee and Scripps
acknowledge that Scripps has received, and expects to continue to receive,
funding from the United States Government in support of Scripps' research
activities. Licensee and Scripps acknowledge and agree that their respective
rights and obligations pursuant to this Agreement shall be subject to Scripps'
obligations and the rights of the United States Government, if any, which arise
or result from Scripps' receipt of research support from the United States
Government, including without limitation, the grant by Scripps to the United
States a non-exclusive, irrevocable, royalty-free license to Scripps Technology
and Scripps Patent Rights licensed hereunder for governmental purposes.
6.4 Reservation of Rights. Scripps and any and all
co-owners of Scripps Technology or Scripps Patent Rights reserves the right to
use for any non-commercial research purposes and the right to allow other
nonprofit institutions to use for any noncommercial research purposes any
Scripps Technology and Scripps Patent Rights licensed hereunder, without Scripps
and any and all co-owners of Scripps Technology or Scripps Patent Rights or such
other institutions being obligated to pay Licensee any royalties or other
compensation.
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7. Confidentiality and Publication.
7.1 Treatment of Confidential Information. The
parties agree that during the term of this Agreement, and for a period of three
(3) years after this Agreement terminates, a party receiving Confidential
Information of the other party will (i) maintain in confidence such Confidential
Information to the same extent such party maintains its own proprietary
industrial information, (ii) not disclose such Confidential Information to any
third party without prior written consent of the other party and (iii) not use
such Confidential Information for any purpose except those permitted by this
Agreement.
7.2 Publications. Licensee agrees that Scripps shall
have a right to publish in accordance with its general policies.
7.3 Publicity. Except as otherwise provided herein or
required by law, no party shall originate any publication, news release or other
public announcement, written or oral, whether in the public press, stockholders'
reports, or otherwise, relating to this Agreement or to any sublicense
hereunder, or to the performance hereunder or any such agreements, without the
prior written approval of the other party, which approval shall not be
unreasonably withheld. Scientific publications published in accordance with
Section 7.2 of this Agreement shall not be construed as publicity governed by
this Section 7.3.
8. Term and Termination.
8.1 Term. Unless terminated sooner in accordance with
the terms set forth herein, this Agreement, and the license granted hereunder,
shall terminate as provided in Section 2.6 hereof.
8.2 Termination Upon Default. Any one or more of the
following events shall constitute an event of default hereunder: (i) the failure
of a party to pay any amounts when due hereunder and the expiration of thirty
(30) days after receipt of a written notice requesting the payment of such
amount; (ii) the failure of a party to perform any obligation required of it to
be performed hereunder, and the failure to cure within sixty (60) days after
receipt of notice from the other party specifying in reasonable detail the
nature of such default. Upon the occurrence of any event of default, the
non-defaulting party shall deliver to the defaulting party written notice of
intent to terminate, such termination to be effective upon the date set forth in
such notice.
Such termination rights shall be in addition to and not in
substitution for any other remedies that may be available to the non-defaulting
party. Termination pursuant to this Section 8.2 shall not relieve the defaulting
party from liability and damages to the other party for breach of this
Agreement. Waiver by either party of a single default or a succession of
defaults shall not deprive such party of any right to terminate this Agreement
arising by reason of any subsequent default.
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8.3 Termination Upon Bankruptcy or Insolvency. This
Agreement may be terminated by Scripps giving written notice of termination to
Licensee upon the filing of bankruptcy or bankruptcy of Licensee or the
appointment of a receiver of any of Licensee's assets, or the making by Licensee
of any assignment for the benefit of creditors, or the institution of any
proceedings against Licensee under any bankruptcy law. Termination shall be
effective upon the date specified in such notice.
8.4 Rights Upon Expiration. Neither party shall have
any further rights or obligations upon the expiration of this Agreement upon its
regularly scheduled expiration date with respect to this Agreement, other than
the obligation of Licensee to make any and all reports and payments for the
final quarter period. Provided, however, that upon such expiration, each party
shall be required to continue to abide by its non-disclosure obligations as
described in Section 7.1, and Licensee shall continue to abide by its obligation
to indemnify Scripps and any and all co-owners of Scripps Technology or Scripps
Patent Rights as described in Section 4.3 and by its obligations under Section
6.2 hereof.
8.5 Rights Upon Termination. Notwithstanding any
other provision of this Agreement, upon any termination of this Agreement prior
to the regularly scheduled expiration date of this Agreement, the license
granted hereunder shall terminate. Except as otherwise provided in Section 8.6
of this Agreement with respect to work-in-progress, upon such termination,
Licensee shall have no further right to develop, manufacture or market any
Licensed Product, or to otherwise use any Scripps Patent Rights or any Scripps
Technology not otherwise includable therein. Upon any such termination, Licensee
shall promptly return all materials, samples, documents, information, and other
materials which embody or disclose Scripps Patent Rights or any Scripps
Technology not otherwise includable therein; provided, however, that Licensee
shall not be obligated to provide Scripps with proprietary information which
Licensee can show that it independently developed. Any such termination shall
not relieve either party from any obligations accrued to the date of such
termination. Upon such termination, each party shall be required to abide by its
nondisclosure obligations as described in Section 7.1, and Licensee shall
continue to abide by its obligations to indemnify Scripps and any and all
co-owners of Scripps Technology or Scripps Patent Rights as described in Section
4.3 and by its obligations under 6.2 hereof.
8.6 Work-in-Progress. Upon any such early termination
of the license granted hereunder in accordance with this Agreement, Licensee
shall be entitled to finish any work-in-progress and to sell any completed
inventory of a Licensed Product covered by such license which remain on hand as
of the date of the termination, so long as Licensee pays to Scripps the
royalties applicable to said subsequent sales in accordance with the terms and
conditions as set forth in this Agreement, provided that no such sales shall be
permitted after the expiration of six (6) months after the date of termination.
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9. Assignment; Successors.
9.1 Assignment. Any and all assignments of this
Agreement or any rights granted hereunder by Licensee are void except (i) to an
Affiliate of Licensee or (ii) as expressly permitted hereunder, without the
prior written consent of Scripps not be unreasonably withheld.
9.2 Binding Upon Successors and Assigns. Subject to
the limitations on assignment herein, this Agreement shall be binding upon and
inure to the benefit of any successors in interest and assigns of Scripps and
Licensee. Any such successor or assignee of Licensee's interest shall expressly
assume in writing the performance of all the terms and conditions of this
Agreement to be performed by Licensee.
10. General Provisions.
10.1 Independent Contractors. The relationship
between Scripps and Licensee is that of independent contractors. Scripps and
Licensee are not joint venturers, partners, principal and agent, master and
servant, employer or employee, and have no other relationship other than
independent contracting parties. Scripps and Licensee shall have no power to
bind or obligate each other in any manner, other than as is expressly set forth
in this Agreement.
10.2 Arbitration. Any controversy or claim arising
out of or relating to this Agreement, or the breach thereof, shall be settled by
binding arbitration in accordance with the Commercial Arbitration Rules of the
American Arbitration Association ("AAA"), and the procedures set forth below. In
the event of any inconsistency between the Rules of AAA and the procedures set
forth below, the procedures set forth below shall control. Judgment upon the
award rendered by the arbitrators may be enforced in any court having
jurisdiction thereof.
10.2.1 Location. The location of the
arbitration shall be in the County of San Diego.
10.2.2 Selection of Arbitrators. The
arbitration shall be conducted by a panel of three neutral arbitrators who are
independent and disinterested with respect to the parties, this Agreement, and
the outcome of the arbitration. Each party shall appoint one neutral arbitrator,
and these two arbitrators so selected by the parties shall then select the third
arbitrator. If one party has given written notice to the other party as to the
identity of the arbitrator appointed by the party, and the party thereafter
makes a written demand on the other party to appoint its designated arbitrator
within the next thirty days, and the other party fails to appoint its designated
arbitrator within ten days after receiving said written demand, then the
arbitrator who has already been designated shall appoint the other two
arbitrators.
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10.2.3 Discovery. Unless the parties
mutually agree in writing to some additional and specific pre-hearing discovery,
the only pre-hearing discovery shall be (a) reasonably limited production of
relevant and non-privileged documents, and (b) the identification of witnesses
to be called at the hearing, which identification shall give the witness's name,
general qualifications and position, and a brief statement as to the general
scope of the testimony to be given by the witness. The arbitrators shall decide
any disputes and shall control the process concerning these pre-hearing
discovery matters. Pursuant to the Rules of AAA, the parties may subpoena
witnesses and documents for presentation at the hearing.
10.2.4 Case Management. Prompt resolution of
any dispute is important to both parties; and the parties agree that the
arbitration of any dispute shall be conducted expeditiously. The arbitrators are
instructed and directed to assume case management initiative and control over
the arbitration process (including scheduling of events, pre-hearing discovery
and activities, and the conduct of the hearing), in order to complete the
arbitration as expeditiously as is reasonably practical for obtaining a just
resolution of the dispute.
10.2.5 Remedies. The arbitrators may grant
any legal or equitable remedy or relief that the arbitrators deem just and
equitable, to the same extent that remedies or relief could be granted by a
state or federal court, provided however, that no punitive damages may be
awarded. No court action may be maintained seeking punitive damages. The
decision of any two of the three arbitrators appointed shall be binding upon the
parties.
10.2.6 Expenses. The expenses of the
arbitration, including the arbitrators' fees, expert witness fees, and
attorney's fees, may be awarded to the prevailing party, in the discretion of
the arbitrators, or may be apportioned between the parties in any manner deemed
appropriate by the arbitrators. Unless and until the arbitrators decide that one
party is to pay for all (or a share) of such expenses, both parties shall share
equally in the payment of the arbitrators' fees as and when billed by the
arbitrators.
10.2.7 Confidentiality. Except as set forth
below, the parties shall keep confidential the fact of the arbitration, the
dispute being arbitrated, and the decision of the arbitrators. Notwithstanding
the foregoing, the parties may disclose information about the arbitration to
persons who have a need to know, such as directors, trustees, management
employees, witnesses, experts, investors, attorneys, lenders, insurers, and
others who may be directly affected. Additionally, if a party has stock which is
publicly traded, the party may make such disclosures as are required by
applicable securities laws. Further, if a party is expressly asked by a third
party about the dispute or the arbitration, the party may disclose and
acknowledge in general and limited terms that there is a dispute with the other
party which is being (or has been) arbitrated. Once the arbitration award has
become final, if the arbitration award is not promptly satisfied, then these
confidentiality provisions shall no longer be applicable.
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10.3 Entire Agreement; Modification. This Agreement
sets forth the entire agreement and understanding between the parties as to the
subject matter hereof. There shall be no amendments or modifications to this
Agreement, except by a written document which is signed by both parties.
10.4 California Law. This Agreement shall be
construed and enforced in accordance with the laws of the State of California
without regard to the conflicts of laws principles thereof.
10.5 Headings. The headings for each article and
section in this Agreement have been inserted for convenience of reference only
and are not intended to limit or expand on the meaning of the language contained
in the particular article or section.
10.6 Severability. Should any one or more of the
provisions of this Agreement be held invalid or unenforceable by a court of
competent jurisdiction, it shall be considered severed from this Agreement and
shall not serve to invalidate the remaining provisions thereof. The parties
shall make a good faith effort to replace any invalid or unenforceable provision
with a valid and enforceable one such that the objectives contemplated by them
when entering this Agreement may be realized.
10.7 No Waiver. Any delay in enforcing a party's
rights under this Agreement or any waiver as to a particular default or other
matter shall not constitute a waiver of such party's rights to the future
enforcement of its rights under this Agreement, excepting only as to an express
written and signed waiver as to a particular matter for a particular period of
time.
10.8 Name. Whenever there has been an assignment or a
sublicense by Licensee as permitted by this Agreement, the term "Licensee" as
used in this Agreement shall also include and refer to, if appropriate, such
assignee or sublicensee.
10.9 Attorneys' Fees. In the event of a dispute
between the parties hereto or in the event of any default hereunder, the party
prevailing in the resolution of any such dispute or default shall be entitled to
recover its reasonable attorneys' fees and other costs incurred in connection
with resolving such dispute or default.
10.10 Notices. Any notices required by this Agreement
shall be in writing, shall specifically refer to this Agreement and shall be
sent by registered or certified airmail, postage prepaid, or by telefax, telex
or cable, charges prepaid, or by overnight courier, postage prepaid and shall be
forwarded to the respective addresses set forth below unless subsequently
changed by written notice to the other party:
For Scripps: The Scripps Research Institute
10550 North Torrey Pines Road, TPC-9
La Jolla, California 92037
Attention: Director, Technology Development
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Fax No.: (858)784-9910
and copy to The Scripps Research Institute
10550 North Torrey Pines Road, TPC-8
La Jolla, California 92037
Attention: General Counsel
Fax No.: (858)784-9910
For Licensee: Cell Matrix
4 Hook Road
Sharon Hill, Pennsylvania 19079
Attention: Legal Department
Fax No.: (610)237-7115
Notice shall be deemed delivered upon the earlier of (i) when received, (ii)
three (3) days after deposit into the mail, or (iii) the date notice is sent via
telefax, telex or cable, (iv) the day immediately following delivery to
overnight courier (except Sunday and holidays).
10.11 Compliance with U.S. Laws. Nothing contained in
this Agreement shall require or permit Scripps or Licensee to do any act
inconsistent with the requirements of any United States law, regulation or
executive order as the same may be in effect from time to time.
IN WITNESS WHEREOF, the parties have executed this Agreement
by their duly authorized representatives as of the date set forth above.
SCRIPPS: LICENSEE:
THE SCRIPPS RESEARCH INSTITUTE CELL MATRIX INC.
By: /s/ Arnold LaGuardia By: [ILLEGIBLE]
---------------------------------- ---------------------------------
Arnold LaGuardia Title: Chairman
Title: Executive Vice President
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EXHIBIT A
DISCLOSURE OF TECHNOLOGY
[***]
*** 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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[103 Pages of Proprietary Information Deleted Pursuant to Confidential Treatment
Request]
<PAGE>
EXHIBIT B
FORM OF SUBLICENSE
This Sublicense Term Sheet is entered into and made effective
as of ______________________________________, 20___by and between______________
______________________, a __________ located at _______________________________
("Licensee") and_________________________________________, a___________________
located at ___________________________________________________ ("Sublicensee").
Grant of Sublicense. Licensee hereby grants to Sublicensee a
sublicense under and on all the same terms and conditions of that certain
License Agreement between Licensee and The Scripps Research Institute, a
California nonprofit public benefit corporation ("Scripps") attached hereto as
Exhibit I (the "Master License Agreement"), except as set forth below:
a. Technology subject to Sublicense: __________
________________________________________________________________________________
_______________________________________________________________________________.
b. Term:_______________________________________
________________________________________________________________________________
_______________________________________________________________________________.
c. Royalty Payments:___________________________
________________________________________________________________________________
_______________________________________________________________________________.
d. Commercial Development Obligations:_________
________________________________________________________________________________
_______________________________________________________________________________.
By its signature below, Sublicensee agrees to be bound by all
of the terms and conditions of the Master License Agreement, as modified hereby,
for the benefit of Licensee and Scripps.
LICENSEE: SUBLICENSEE:
___________________________________ ____________________________________
By:________________________________ By:_________________________________
Title:_____________________________ Title:______________________________
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EXHIBIT C
DEVELOPMENTAL MILESTONES
<TABLE>
<CAPTION>
Milestones Time from Execution of Agreement
---------- --------------------------------
<S> <C>
Candidate for pre-clinical evaluation selected [***]
Initiation of first clinical trial* [***]
Initiation of phase II clinical trial* [***]
Initiation of phase III clinical trial* [***]
First market license application filed* [***]
</TABLE>
* In any Major Market Country
20
*** 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.
<PAGE>
EXHIBIT D
INTER-INSTITUTIONAL AGREEMENT BETWEEN SCRIPPS AND UCSD
21