EXHIBIT 10.39
CONFIDENTIAL PORTIONS HAVE BEEN OMITTED BASED UPON A REQUEST
FOR CONFIDENTIAL TREATMENT PURSUANT TO RULE 24b-2 OF THE
SECURITIES EXCHANGE ACT OF 1934 AND HAVE BEEN SEPARATELY FILED
WITH THE COMMISSION.
LICENSE AGREEMENT
This License Agreement is entered into and made effective (the
"EFFECTIVE DATE") as of the latter of the dates on which EASTERN VIRGINIA
MEDICAL SCHOOL and ACSENTIENT, INC. has executed this agreement, by and between
Eastern Virginia Medical School ("LICENSOR") located at 825 Fairfax Avenue,
Norfolk, Virginia 23507, U.S.A., and AcSentient Inc., a Delaware corporation
("LICENSEE") located at 209 Chalon Drive, Cary, North Carolina 27511, with
respect to the facts set forth below.
RECITALS
A. Licensor is engaged in fundamental scientific research
including research relating to Topical Formulation(s) Containing Aminocaproic
Acid and uses thereof.
B. Licensee is engaged in research, development and
commercialization of ophthalmolic technology.
C. Licensor has disclosed to Licensee certain technology
described in Exhibit A and incorporated herein by reference (the "PATENT AND
TRADEMARK SCHEDULE").
D. Licensor has the exclusive right to grant a license to the
technology and Trademark described in "Parent and Trademark Schedule", subject
to certain rights of the U.S. Government to use such technology for its own
purposes, resulting from the receipt by Licensor of certain funding from the
U.S. Government.
E. Licensor desires to grant to Licensee, and Licensee wishes to
acquire, an exclusive worldwide right and license to the technology and
Trademark described in the "Patent and Trademark Schedule" and to certain parent
rights and know-how of Licensor with respect thereto, subject to the terms and
conditions set forth herein, with a view to developing and marketing therapeutic
products within the Field (as defined below).
AGREEMENT
NOW, THEREFORE, in consideration of the mutual covenants and conditions
set forth herein, Licensor and Licensee hereby agree as follows:
1. Definitions.
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 direct or
indirect beneficial ownership of at least fifty percent (50%) of the voting
stock in the case of a corporation, or of the rights to receive distributable
net income, in the
case of any other business entity, whether through the ownership of a majority
of the outstanding voting securities or by contract or otherwise.
1.2 Confidential Information. The term "CONFIDENTIAL
INFORMATION" shall mean any and all proprietary or confidential information of
Licensor or Licensee, as applicable, which may be exchanged between the parties
at any time and from time to time during the term of this Agreement. Information
to treated as "confidential" shall be marked "confidential" at the time of
disclosure. Information that is disclosed orally or visually shall be identified
as "confidential" at the time of disclosure and its confidential status shall be
confirmed in writing within 20 days of disclosure. 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 as clearly established by the receiving party's
records, 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 and such publication does not violate any confidentiality
obligation.
1.3 Field. The term "FIELD" shall mean topical formulation(s)
containing aminocaproic acid, the method to produce and apply the topical
formulation(s) and all ophthalmic uses of the topical formulation(s).
1.4 Know-How. The term "KNOW-HOW" shall mean all non-public
materials, information, data and other 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, which are related to the Field and are necessary or useful
for Licensee to use, develop or market the Licensed Products or seek regulatory
approval therefor.
1.5 Licensed Product. The term "LICENSED PRODUCT" shall mean
any product, the development, manufacture, use, sale or offer for sale of which
would, but for the rights granted under this Agreement, infringe one or more
pending or issued claims of Licensor Patent and Trademark Rights in any country,
or the sale or marketing of which would infringe Licensor Trademark in any
country.
1.6 Net Sales. The term "NET SALES" shall mean the gross
amount invoiced by Licensee, or its Affiliates and sublicensees, or any of them,
on all sales of Licensed Products,less: (i) trade discounts earned or granted
for quantity purchases, prompt payment discounts and cash discounts, to the
extent actually allowed, (ii) credits for claims, allowances, retroactive price
reductions, rejections, returned goods or billing errors, to the extent actually
allowed, (iii) custom duties, if any, prepaid freight and insurance, and (iv)
sales taxes or other governmental charges actually paid in connection with sales
of Licensed Products (but excluding what is commonly known as income taxes). For
purposes of determining Net Sales, a sale shall be deemed to have occurred when
an invoice therefor shall be generated by the Licensee and the Licensed Product
has been shipped for delivery. 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.
* CONFIDENTIAL PORTIONS HAVE BEEN OMITTED BASED UPON A REQUEST FOR CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934 AND
HAVE BEEN SEPARATELY FILED WITH THE COMMISSION.
2
[ * ]
[ * ]
[ * ]
[ * ]
[ * ]
[ * ].
1.7 Licensor Patent and Trademark Rights. The term "LICENSOR
PATENT AND TRADEMARK RIGHTS" shall mean (i) any and all U.S. and foreign patent
and trademark applications covering Licensor Technology and/or Licensor
Trademarks owned by or assignable to the Licensor, as set forth in Exhibit A
attached hereto and incorporated herein by reference, (ii) the granted patents
and/or registered trademarks proceeding from such applications, (iii) all
divisions, continuations, continuations-in-part, reissues, reexaminations,
extensions and additions thereof, and (iv) rights, at common law or otherwise,
in Licensor Trademark, so long as said patents and/or trademarks 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.
1.8 Licensor Technology. The term "LICENSOR TECHNOLOGY" shall
mean, collectively, the Licensor Patent and Trademark Rights and Know-How and
all enhancements and improvements thereto made by Licensor during the term of
this Agreement.
1.9 Licensor Trademark. The term "LICENSOR TRADEMARK"
shall mean the trademark disclosed in Exhibit A attached hereto and incorporated
herein by reference.
2. License Terms and Conditions.
2.1 Grant of License. Licensor hereby grants to Licensee the
exclusive, worldwide license, including the right to sublicense, to Licensor
Technology, to make, to have made, to use, to offer for sale and to sell
Licensed Products in the Field, and to use the Licensor Trademark on or in
association with such Licensed Products, subject to the terms of this Agreement.
2.2 Initial Royalty. In partial consideration for the rights
granted under this Agreement, Licensee shall pay to Licensor a nonrefundable
royalty on the Effective Date in the amount of Sixty-Five Thousand Dollars
($65,000). The royalty described in this Section 2.2 is consideration for the
grant and continuation of the license hereunder, and Licensor shall have no
obligation to return any portion of such royalty for any reason.
2.3 Running Royalties.
2.3.1 Percentage Royalty. As additional
consideration for the rights granted under this Agreement, Licensee shall pay to
Licensor a running royalty on a country-by-country basis in the amount of [ * ]
of Net Sales of Licensed Products.
2.4 Combination Products.
2.4.1 Definition of Combination Product. As used
herein, the term "COMBINATION PRODUCT" shall mean a Licensed Product sold by
Licensee in a formulation which contains one or more additional Active
Ingredients which are the subject of granted patents owned by or assigned to
Licensee. For the purposes of this Agreement, "Active Ingredient" shall mean any
* CONFIDENTIAL PORTIONS HAVE BEEN OMITTED BASED UPON A REQUEST FOR CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934 AND
HAVE BEEN SEPARATELY FILED WITH THE COMMISSION.
3
composition of matter approved by the United States Food and Drug Administration
for the treatment of the same indication(s) as Licensed Product.
2.4.2 Royalty Payable on Combination Products. The
royalty payable on Combination Products shall be the royalty rate set forth in
Section 2.2.1 above based on a pro rata portion of Net Sales of Combination
Products in accordance with the following formula:
X = A/B, where
X = the pro rata portion of Net Sales attributable to Licensor
Patent Rights or other Licensor Technology licensed herein (expressed as a
percentage), and
A = the fair market value of the component in the Combination
Product utilizing Licensor Technology licensed hereunder, and
B = A plus the fair market value of one or more additional
Active Ingredients components.
The fair market values described above shall be determined by
the parties hereto in good faith. In the absence of agreement as to the fair
market value of all of the components contained in a Combination Product, the
fair market value of each component shall be determined by arbitration in
accordance with the provisions of Section 10.2 hereof.
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 [ * ] after the end of each calendar quarter during the term
of this Agreement, based upon the Net Sales of Licensed Products and Combination
Products during such preceding calendar quarter, commencing with the calendar
quarter in which the first commercial sale of any Licensed Product or
Combination 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 [ * ] after the end of each calendar
quarter, based upon the Net Sales of Licensed Products and Combination 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 Agreement shall expire
when the last of the royalty obligations set forth in Section 2.8 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
(i) the term of this Agreement shall be so shortened or this Agreement shall 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 or (ii) this Agreement
may be terminated at the sole option of the Licensee.
* CONFIDENTIAL PORTIONS HAVE BEEN OMITTED BASED UPON A REQUEST FOR CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934 AND
HAVE BEEN SEPARATELY FILED WITH THE COMMISSION.
4
2.7 Sublicense, Assignment or Transfer. Licensee shall not
have the right to grant sublicenses to any party with respect to the rights
conferred upon Licensee under this Agreement, without the prior written
authorization of Licensor. Any such sublicense shall be subject in all respects
to the restrictions, exceptions, obligations, reports, termination provisions,
and other provisions contained in this Agreement. Licensee shall pay Licensor
royalties of all Net Sales of such sublicensee in accordance with Section 2.3 of
this agreement, the same as if said Net Sales had been made by Licensee;
provided, however, that sales of Licensed Products by Licensee to a sublicensee
which is a reseller shall be excluded from Net Sales, and only the subsequent
sale of such Licensed Products by such sublicensee to an unrelated party shall
be deemed to be Net Sales hereunder. Licensee shall pay Licensor [ * ] of all
income or other compensation, equity or otherwise, received or provided to
Licensee as a result of any transfer or assignment.
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 Licensor Patent
and Trademark Rights utilized by or in such Licensed Product in each such
country.
2.9 Reports. Licensee shall furnish to Licensor at the same
time as each royalty payment is made by Licensee, a detailed written report of
Net Sales of the Licensed Products and Combination 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 and Combination Product to be verified.
Licensor shall have the right to appoint an independent certified public
accounting firm approved by Licensee, which approval shall not be unreasonably
withheld, to audit and copy the records of Licensee, its Affiliates and
sublicensees as necessary to verify the royalties payable pursuant to this
Agreement. Licensee, its Affiliates and sublicensees shall pay to Licensor an
amount equal to any additional royalties to which Licensor is entitled as
disclosed by the audit, plus interest thereon at the rate of [ * ] per month.
Such audit shall be at Licensor's expense; provided, however, that if the audit
discloses that Licensor was underpaid royalties with respect to any Licensed
Product by at least [ * ] for any calendar quarter, then Licensee, its
Affiliates or sublicensee, as the case may be, shall reimburse Licensor for any
such audit costs. Licensor 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 Licensor 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 [ * ] [ * ] after the calendar quarter to which the record applies.
2.11 Foreign Sales. The remittance of royalties payable on Net
Sales outside the United States shall be payable to Licensor 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 county where the sale was
made on which the royalty was based to the credit and account of Licensor or its
nominee in any commercial bank or
* CONFIDENTIAL PORTIONS HAVE BEEN OMITTED BASED UPON A REQUEST FOR CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934 AND
HAVE BEEN SEPARATELY FILED WITH THE COMMISSION.
5
trust company of Licensor's choice located in that country, prompt written
notice of which shall be given by Licensee to Licensor.
2.12 Foreign Taxes. Any tax required to be withheld by
Licensee under the laws of any foreign country for the accounts of Licensor
shall be promptly paid by Licensee for and on behalf of Licensor to the
appropriate governmental authority, and Licensee shall use its best efforts to
furnish Licensor 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 Licensor's behalf shall be deducted from royalty
payments due Licensor.
3. Patent and Trademark Matters.
3.1 Patent and Trademark Prosecution and Maintenance. From and
after the Effective Date, the provisions of this Section 3 shall control the
prosecution and maintenance of any patent and/or trademark included within
Licensor Patent and Trademark Rights. Subject to the requirements, limitations
and conditions set forth in this Agreement, Licensor shall (i) own, prepare,
file and prosecute the United States and foreign patent and trademark
applications within Licensor Patent and Trademark Rights (including any
interferences and foreign oppositions), (ii) maintain the patents and trademarks
issuing therefrom (and file extensions thereto upon request of Licensee) and
(iii) direct and control all activities conducted pursuant to the foregoing
clauses (i) and (ii). Licensor 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 Licensor Patent and Trademark Rights.
Licensor shall use its best efforts to implement all reasonable requests made by
Licensee with regard to the preparation, filing, prosecution and/or maintenance
of the patent and trademark applications and/or patents and trademarks within
Licensor Patent and Trademark Rights, but it is understood that Licensor is not
obligated to implement such Licensee requests. In no event, however, shall
Licensor file or prosecute a patent application for Licensor Patent and
Trademark Rights when Licensee has demonstrated to Licensor's satisfaction that
the patent application filing or prosecution would be prejudicial to plans for
worldwide development and commercialization of the Licensor Technology.
3.2 Information to Licensee. Licensor shall keep Licensee
informed with regard to the patent and/or trademark application and maintenance
processes. Licensor shall deliver to Licensee copies of all patent and/or
trademark applications, amendments, related correspondence, and other related
matters.
3.3 Patent and Trademark Costs. Licensee acknowledges and
agrees that Licensor does not have independent funding to cover patent and
trademark costs, and that the license granted hereunder is in part in
consideration for Licensee's assumption of the costs and expenses as described
herein. Licensee shall pay for all reasonable expenses incurred by Licensor
pursuant to Section 3.1 hereof. Licensee agrees to pay all future patent and
trademark expenses directly or to reimburse Licensor for the payment of such
expenses. In the event Licensee gives written notice to Licensor that Licensee
elects to discontinue payment for the filing, prosecution and/or maintenance of
any patent or trademark application, any such application and/or patent and
trademark shall be excluded from the definition of Licensor Patent and Trademark
Rights and from the scope of the license granted under this Agreement, and all
rights relating thereto shall revert to Licensor and may be freely licensed by
Licensor, and Licensee shall have no rights thereunder. Licensee shall give
Licensor at least [ * ] 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.
* CONFIDENTIAL PORTIONS HAVE BEEN OMITTED BASED UPON A REQUEST FOR CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934 AND
HAVE BEEN SEPARATELY FILED WITH THE COMMISSION.
6
3.4 Ownership. The patent and trademark applications filed and
the patents and trademarks obtained by Licensor pursuant to Section 3.1 hereof
shall be owned solely by Licensor, assigned to Licensor and deemed a part of
Licensor Patent and Trademark Rights.
3.5 Licensor Right to Pursue Patent and/or Trademark. If at
any time during the term of this Agreement, Licensee's rights with respect to
Licensor Patent and Trademark Rights are terminated, Licensor shall have the
right to take whatever action Licensor deems appropriate to obtain or maintain
the corresponding patent and/or trademark protection at its own expense. If
Licensor pursues patents under this Section 3.5, Licensee agrees to reasonably
cooperate, including by providing, at no charge to Licensor, 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 Licensor Patent and Trademark Rights
and shall defend all charges of infringement arising as a result of the exercise
of Licensor Patent and Trademark Rights by Licensee, its Affiliates or
sublicensees, unless otherwise agreed to between Licensor 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 Licensor, which consent shall not be unreasonably withheld.
Licensor shall permit any action to be brought in its name if required by law,
and Licensee shall hold Licensor harmless from any costs, expenses of liability
respecting all such infringements or charges of infringement. Licensor agrees to
provide, at a reasonable hourly rate of compensation, all 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
reimburse Licensor's out-of-pocket expenses. In the event Licensee fails to
prosecute any such infringement, Licensee shall notify Licensor in writing
promptly and Licensor shall have the right to prosecute such infringement on its
own behalf. Failure on the part of Licensee to prosecute any such infringement
that Licensor subsequently elects to prosecute on its own behalf shall be
grounds for termination of the license granted to Licensee hereunder, at the
option of Licensor.
3.6.2 Credit; Allocation of Recovery. Any damages
or other recovery from an infringement action undertaken by Licensee pursuant to
Section 3.6.1 shall be used first, to reimburse the parties for the costs and
expenses incurred in such action (including reasonable attorneys' fees) and
thereafter, shall be allocated between the parties as follows: (i) [ * ] to
Licensor and (ii) [ * ] 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 Licensor.
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 Licensor Technology and Licensor Patent and
Trademark 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
propose a Development Plan (Exhibit B) and shall keep Licensor generally
informed as to Licensee's progress in such development, production and sale,
including its efforts, if any, to sublicense Licensor
* CONFIDENTIAL PORTIONS HAVE BEEN OMITTED BASED UPON A REQUEST FOR CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934 AND
HAVE BEEN SEPARATELY FILED WITH THE COMMISSION.
7
Technology and Licensor Patent and Trademark Rights, and Licensee shall deliver
to Licensor a quarterly written report and such other reports as Licensor may
reasonably request. The parties hereto acknowledge and agree that achievement of
the milestones described in Exhibit B 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 B.
In the event Licensor has a reasonable basis to believe that Licensee is not
using reasonable efforts and due diligence as required hereunder, upon notice by
Licensor to Licensee which specifies the basis for such belief, Licensor and
Licensee shall negotiate in good faith to attempt to mutually resolve the issue.
In the event Licensor 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 cured within [ * ] after the arbitrator's
decision, Licensor 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 development, production, distribution, sale and use of any Licensed
Product, at Licensee's expense, including, without limitation, any safety and
efficacy studies. Licensor shall provide such materials, information and
assistance as may be reasonably requested by Licensee to obtain such
governmental approvals. Licensee shall have sole responsibility for any warning
labels, packaging and instructions as to the use of Licensed Products or
Combination Products and for the quality control for any Licensed Product or
Combination Products.
4.3 Indemnity. Licensee hereby agrees to indemnify, defend and
hold harmless Licensor 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 Combination Products or any claims arising
from the use of any Licensor Patent and Trademark Rights or Licensor 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 have the right to defend such a claim with counsel of its
own choosing. Licensee shall have Licensor 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 or Combination Products.
4.3.1 Insurance Requirements. The LICENSEE agrees
that it will secure General Liability or Products Liability Insurance covering
the sale and use of Licensed Products, and will require its underwriters to name
the LICENSOR as an additional insured under the policies. The LICENSEE shall
provide to the LICENSOR copies of the policies of insurance within 30 days of
issuance of the coverages. The LICENSEE agrees to obtain and maintain in effect
so long as it sells or offers the same for sale, general liability insurance
extending to bodily injury and/or property damage with limits of one million
dollars ($1,000,000) per occurrence with no annual aggregate, and to products
liability with limits of one million dollars ($1,000,000) per occurrence with no
annual aggregate. These policy coverages shall be purchased from and issued by a
carrier (or carriers) licensed to do business in States specified by the
LICENSOR, and shall extend to the obligations of indemnification assumed by the
LICENSEE pursuant to the terms of this Agreement. The
* CONFIDENTIAL PORTIONS HAVE BEEN OMITTED BASED UPON A REQUEST FOR CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934 AND
HAVE BEEN SEPARATELY FILED WITH THE COMMISSION.
8
LICENSEE shall provide certificates evidencing such insurance coverage to the
LICENSOR promptly after the execution of this Agreement.
4.4 Patent Marking. To the extent required by applicable
law, Licensee shall mark all Licensed Products or Combination Products or their
containers in accordance with the applicable patent marking laws.
4.5 No Use of Name. The use of the name "EASTERN VIRGINIA
MEDICAL SCHOOL", 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, if at all, 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. Except as provided in Section 3.1
hereof, 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, except as provided in Section
3.1 hereof, Licensee shall assure that all foreign laws affecting this Agreement
or the sale of Licensed Products or Combination Products are fully satisfied.
5. Representations and Warranties of License.
5.1 Power and Authority. Licensor hereby represents and
warrants that it has full right, authority and power to enter into this
Agreement and to grant the exclusive license under the Licensor Patent and
Trademark Rights and to perform its obligations under this Agreement. Upon
execution and delivery by Licensee, this Agreement shall constitute a valid and
binding agreement of Licensor enforceable against it in accordance with its
terms.
5.2 Title and Validity. Licensor hereby represents and
warrants that it is the sole owner of all right, title and interest in and to
the Licensor Patent and Trademark Rights. To Licensor's knowledge, there are no
claims or suits challenging Licensor's ownership or right to use the Licensor
Patent and Trademark Rights, or alleging that any of the Licensor Patent and
Trademark Rights infringe any rights of any third party, nor does there exist
any basis therefor. To Licensor's knowledge, it is not necessary for Licensee to
obtain any royalty bearing licenses from any third party in order to fully
exercise the rights granted by Licensor hereunder. Licensor has no knowledge of
any fact that casts substantial doubt on the validity of any of the Licensor
Patent and Trademark Rights as of this date.
5.3 No Conflict. Licensor hereby represents and warrants that
no other person or organization presently has any assignment, option, or license
under the Licensor Patent and Trademark Rights with respect to the manufacture,
use or sale of Licensed Product in the United States or anywhere in the world.
Execution, delivery and consummation of this Agreement will not result in the
breach of or give rise to cause for termination of any agreement or contract to
which Licensor may be a party or, to Licensor's knowledge, which otherwise
relates to the Licensor Patent and Trademark Rights or the Licensed Products.
Neither Licensor nor any of its Affiliates after the Effective Date shall enter
into any agreement or take or fail to take any action which shall restrict its
legal right to grant to Licensee the rights and benefits contemplated under this
Agreement.
9
5.4 Indemnity. It is understood that if any of the
representations and warranties hereunder are not true and correct as of the date
hereof and Licensee incurs damages, costs or other expenses as a result of such
falsity or circumstances falsely represented, Licensor shall defend, indemnify
and hold harmless Licensee and its Affiliates for any such damages, costs or
expenses incurred.
5.5 Disclaimer. Subject to the foregoing, LICENSOR MAKES NO
OTHER WARRANTIES CONCERNING LICENSOR PATENT AND TRADEMARK RIGHTS OR LICENSOR
TECHNOLOGY COVERED BY THIS AGREEMENT, INCLUDING WITHOUT LIMITATION, ANY EXPRESS
OR IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE AS TO
LICENSOR PATENT AND TRADEMARK RIGHTS, LICENSOR TECHNOLOGY OR ANY LICENSED
PRODUCT.
6. Interests in Intellectual Property Rights.
6.1 Preservation of Title. Licensor shall retain full
ownership and title to Licensor Technology, and Licensor Patent and Trademark
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 [ * ]License to Improvements. Licensee hereby grants to
Licensor a non-exclusive, [ * ] license to any improvement to Licensor
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. Licensor hereby grants to Licensee a non-exclusive, royalty
free license to any improvement to Licensor Technology developed by Licensor if
the research was solely sponsored by Licensee.
6.3 Governmental Interest. Licensee and Licensor acknowledge
that Licensor has received, and expects to continue to receive, funding from the
United States Government in support of Licensor's research activities. Licensee
and Licensor acknowledge and agree that their respective rights and obligations
pursuant to this Agreement shall be subject to Licensor's obligations and the
rights of the United States Government, if any, which arise or result from
Licensor's receipt of research support from the United States Government,
including without limitation, the grant by Licensor to the United States a
non-exclusive, irrevocable, royalty-free license to Licensor Technology and
Licensor Patent and Trademark Rights licensed hereunder for governmental
purposes.
6.4 Reservation of Rights. Licensor reserves the right to use
for any non-commercial research purposes and the right to allow other nonprofit
institutions to use for any non-commercial research purposes any Licensor
Technology and Licensor Patent and Trademark Rights licensed hereunder, without
Licensor or such other institutions being obligated to pay Licensee any
royalties or other compensation.
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 [ * ] 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 information,
* CONFIDENTIAL PORTIONS HAVE BEEN OMITTED BASED UPON A REQUEST FOR CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934 AND
HAVE BEEN SEPARATELY FILED WITH THE COMMISSION.
10
(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 Licensor shall have a
right to publish in accordance with its general policies. However, prior to
publication, Licensor shall submit to Licensee copies of proposed publications
which contain subject matter relating to intellectual property licensed
hereunder or to a Licensed Product, and afford Licensee [ * ] to review the
publication(s). Upon timely written request by Licensee, Licensor shall delay
any such publication until the preparation and filing of a patent application
pursuant to Section 3.1, which delay shall not exceed [ * ].
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. Licensee shall not use the name of Licensor or any of
Licensor's employees in any marketing or sales literature or otherwise without
Licensor's prior written approval. Scientific publications published in
accordance with Section 7.2 of this Agreement and disclosures required under the
securities laws 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, the term of this Agreement, and the license granted
hereunder, shall expire 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 [ * ] 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 [ * ] 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 may 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.
8.3 Termination For Financial Considerations. This Agreement,
and the license granted herein, may be terminated by Licensor giving written
notice of termination to Licensee in the event Licensee informs Licensor in
writing of Licensee's inability to pay its debts as they come due, fails to pay
royalties within [ * ] after they are due pursuant to this Agreement, or upon
the appointment of a receiver of any of Licensee's assets, or the making by
Licensee of any assignment for the benefit of creditors. Termination shall be
effective upon the date specified in such
* CONFIDENTIAL PORTIONS HAVE BEEN OMITTED BASED UPON A REQUEST FOR CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934 AND
HAVE BEEN SEPARATELY FILED WITH THE COMMISSION.
11
notice. To the extent permitted by applicable law, in the event that: (i)
Licensee (1) applies for or consents to the appointment of, or the taking of
possession by, a receiver, custodian, trustee or liquidator of all or
substantially all of its property, (2) makes a general assignment for the
benefit of its creditors, (3) commences a case under the United States
Bankruptcy Code, or files a petition seeking to take advantage of any other law
relating to bankruptcy, insolvency, or composition or readjustment, with respect
to substantially all of its debts, or (4) adopts any resolution of its board of
directors or stockholders for the purpose of effecting any of the foregoing; or
(ii) a proceeding or case is commenced without the application or consent of
Licensee that seeks a remedy described in (1) above and such proceeding or case
continues undismissed, or an order, judgment or decree approving or ordering any
of such remedies shall be entered and continue unstayed and in effect, for a
period of [ * ] from and after the date service of process is effected upon
Licensee; then, and in any such event, Licensee will be deemed to have defaulted
under this Agreement, and this Agreement will be deemed to have been terminated
by Licensor as of that date.
8.4 Licensee Termination. Licensee shall have the right to
terminate this Agreement at any time upon three (3) months written notice to
Licensor, and upon payment of all amounts due Licensor through the effective
date of termination.
8.5 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. Licensee shall continue to abide by its obligation to
indemnify Licensor as described in Section 4.3 and by its obligations under
Section 6.2 hereof, and Licensor shall continue to abide by its obligation to
indemnify Licensee as described in Section 5.4.
8.6 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 Licensor Patent and Trademark Rights or any
Licensor 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 Licensor Patent and Trademark
Rights or any Licensor Technology not otherwise includable therein; provided,
however, that Licensee shall not be obligated to provide Licensor 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 Licensor as
described in Section 4.3, and Licensor shall continue to abide by its obligation
to indemnify Licensee as described in Section 5.4.
8.7 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 Licensor the royalties applicable
to said subsequent sales in accordance with the terms and conditions as set
forth in this
* CONFIDENTIAL PORTIONS HAVE BEEN OMITTED BASED UPON A REQUEST FOR CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934 AND
HAVE BEEN SEPARATELY FILED WITH THE COMMISSION.
12
Agreement, provided that no such sales shall be permitted after the expiration
of [ * ] after the date of termination.
8.8 Survival of Sublicenses. In the event that the licenses
granted to Licensee under this Agreement are terminated, any granted sublicenses
shall remain in full force and effect, provided that the sublicensee is not then
in breach of its sublicense agreement and the sublicensee agrees in writing to
be bound and promptly becomes bound to Licensor as a licensor under the terms
and conditions of this Agreement.
9. Assignment; Successors.
9.1 Assignment. Neither this Agreement nor any rights granted
hereunder may be assigned or transferred by Licensee, except to an Affiliate of
Licensee, without the prior written consent of Licensor.
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 permitted assigns of Licensor
and Licensee. Any such successor or permitted 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
Licensor and Licensee is that of independent contractors. Licensor 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. Licensor 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 Dispute Resolution. Any controversy or claim arising out
of or relating to this Agreement, or the breach thereof, shall be settled by an
agreed form of alternative dispute resolution (ADR), including mediation,
arbitration or other form of ADR. If the parties cannot agree on a form of ADR,
dispute shall be settled by binding arbitration in accordance with the
Commercial Arbitration Rules of the American Arbitration Association ("AAA").
Judgment upon the award rendered by the arbitrators may be enforced in any court
having jurisdiction thereof.
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 Applicable Law. This Agreement shall be construed and
enforced in accordance with the laws of the State of Virginia.
10.5 Headings. The headings for each article and section in
this Agreement have been inserted for convenience or reference only and are not
intended to limit or expand on the meaning of the language contained in the
particular article or section.
* CONFIDENTIAL PORTIONS HAVE BEEN OMITTED BASED UPON A REQUEST FOR CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934 AND
HAVE BEEN SEPARATELY FILED WITH THE COMMISSION.
13
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 in 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 Licensor: Eastern Virginia Medical School
825 Fairfax Avenue
Norfolk, Virginia 23507 U.S.A.
Attention: J. Sumner Bell, III, M.D.
President Fax No.: (757) 446-6095
For Licensee: AcSentient, Inc.
209 Chalon Drive
Cary, North Carolina 27511 U.S.A.
Attention: Lisa T. Grimes
Fax No.: (919) 469-2377
Notice shall be deemed delivered upon the earlier of (i) when
received, (ii) three (3) days after deposit into the mail, (iii) the date notice
is sent via telefax, telex or cable, or (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 Licensor 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.
14
10.12 Further Assurances. The parties each, at any time or
from time to time, shall execute and deliver or cause to be delivered such
further assurances, instruments or documents as may be reasonably necessary to
fulfill the terms and conditions of this Agreement.
10.13 Counterparts. This Agreement may be signed in
counterparts which collectively shall constitute a single agreement.
IN WITNESS WHEREOF, the parties have executed this Agreement
by their duly authorized representatives as of the date set forth above.
LICENSOR: LICENSEE:
Eastern Virginia Medical School AcSentient, Inc.
Signature: /s/ J. Sumner Bell, III, M.D. Signature: /s/ Lisa T. Grimes
----------------------------- -------------------
By: J. Sumner Bell, III, M.D. By: Lisa Grimes
Title: President Title: CEO
Date: January 29, 2002 Date:________________________
15
EXHIBIT A
PATENT AND TRADEMARK SCHEDULE
A. Topical Gel Containing Aminocaproic Acid for Preventing Secondary
Hemorrhage Following Hyphem
U.S. Patent No. 5,415,863 Awarded: 5/16/95
B. Topical Gel Containing Aminocaproic Acid Applied to the Eye
U.S. Patent No. 5,505,954 Awarded: 4/9/96
C. Method for Preparing a Topical Aminocaproic Acid Containing Ophthalmic
Gel
U.S. Patent No. 5,547,680 Awarded: 8/20/96
D. Topical Composition for Re-epithelialization of Persistent Epithelial
defects
U.S. Patent No. 5,541,226 Awarded:
E. Registered Trademark: "Caprogel"
U.S. Trademark Reg. No. 2,393,778 Registered: 10/10/00
EXHIBIT B
DEVELOPMENT PLAN
Phase IIIB Clinical Trial
[ * ] [ * ]
[ * ] [ * ]
[ * ] [ * ]
Toxicology Trial
[ * ] [ * ]
[ * ] [ * ]
[ * ] [ * ]
Seek Food and Drug Administration (FDA) Approval
[ * ] [ * ]
[ * ] [ * ]
Market Caprogel
[ * ] [ * ]
* CONFIDENTIAL PORTIONS HAVE BEEN OMITTED BASED UPON A REQUEST FOR CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934 AND
HAVE BEEN SEPARATELY FILED WITH THE COMMISSION.