Exhibit 10.3.4
Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
LICENSE AGREEMENT
This License Agreement ("Agreement") is made effective this 11th day of March,
2002 ("Effective Date"), by and between the University of Iowa Research
Foundation, an Iowa corporation having its principal place of business at 000
Xxxxxxxxxx Xxxxxxxxxx Xxxxxx, Xxxx Xxxx, XX 00000 ("UIRF"), and BioVex Ltd, a
company incorporated under the laws of England and Wales having a principal
place of business at 00 Xxxxxx Xxxx, Xxxxxxxx, Xxxxxx, XX00 0XX, Xxxxxx Xxxxxxx
("Licensee").
WITNESSETH
WHEREAS, under the patent policy of The University of Iowa (UI), all inventions
arising during the normal course of research and teaching at the UI are assigned
to the UIRF to obtain patent or other appropriate intellectual property
protection and license said technology;
WHEREAS, UIRF is owner by assignment from Xxxx. Xxxx X. Xxxxxxx of his invention
and of U.S. Patent Nos. 5,168,062 and 5,385,839, issued December 1, 1992, and
January 31, 1995 respectively, titled TRANSFER VECTORS AND MICROORGANISMS
CONTAINING HUMAN CYTOMEGALOVIRUS (HCMV) IMMEDIATE-EARLY PROMOTER-REGULATORY DNA
SEQUENCE (no foreign filings have been undertaken by the UIRF);
WHEREAS, the development of this invention was sponsored by the National
Institute of Allergy and Infectious Diseases and as a consequence this license
is subject to overriding obligations to the Federal Government under 35 U.S.C.
Section 200-212 and applicable regulations;
WHEREAS, Licensee desires a non-exclusive license to the above United States
patents for their use in gene therapy applications;
WHEREAS, UIRF wishes to grant such a license in accordance with the terms of
this Agreement.
NOW THEREFORE, the parties agree as follows:
ARTICLE I -- DEFINITIONS
1.1 Licensed Patents shall mean U.S. Patent Nos. 5,168,062 and 5,385,839 titled
TRANSFER VECTORS AND MICROORGANISMS CONTAINING HUMAN CYTOMEGALOVIRUS (HCMV)
IMMEDIATE-EARLY PROMOTER-REGULATORY DNA SEQUENCE, by Xxxx. Xxxx X. Xxxxxxx,
issued December 1, 1992 and January 31, 1995 respectively, or any U.S. patents
issuing thereon, including any continuations, continuations-in-part, divisions,
reissues, reexaminations and extensions thereof and patents corresponding
thereto.
1.2 Licensed Products shall mean and include any and all biological materials
and products the making, using, selling or importing of which would, but for
this Agreement, constitute an infringement of one or more Valid Claims of the
Licensed Patents.
1.3 Valid Claim shall mean any claim in an unexpired patent included within
Licensed Patents which claim has not been disclaimed or held invalid or
unenforceable by an unappealed or unappealable decision of a court.
1.4 Licensed Field shall mean the use and/or sale of the Licensed Products FOR
GENE THERAPY APPLICATIONS (INCLUDING GENETIC IMMUNIZATION OR DNA-BASED
VACCINES).
1.5 Licensed Territory shall mean any country in which the making, using,
selling or importing of Licensed Products would, but for the license granted in
this Agreement, infringe one or more Valid Claims of the Licensed Patents.
1.6 Net Sales shall mean the gross amount received by Licensee and/or its
Affiliates and/or its Partners from the sales of Licensed Products within the
Licensed Field in the Licensed Territory to third party customers less:
a) normal and customary rebates, cash and trade discounts actually allowed;
b) credits allowed for returned or damaged goods;
c) insurance and transportation costs; and
d) sales, excise, value added, import and export taxes, and any tariffs and
duties imposed on the transaction, if separately invoiced.
On sales between Licensee and/or its Affiliates and/or its Partners for resale,
the royalty shall be paid on the resale.
1.7 Yearly Accounting Period shall mean an annual period beginning on January 1
and ending on December 31 of the same year.
1.8 Earned Royalties shall mean royalties paid or payable by Licensee to UIRF as
determined with respect to Net Sales.
1.9 Affiliate means any corporation or other business entity in which Licensee
owns or controls, directly or indirectly, at least fifty percent (50%) of the
outstanding stock or other voting rights entitled to elect directors, or in
which Licensee is owned or controlled directly or indirectly by at least fifty
percent (50%) of the outstanding stock or other voting rights entitled to elect
directors.
1.10 For purposes of this Agreement, Partner shall mean any third party company
or legal entity which is not controlled by or under common control with
Licensee, with which Licensee has a joint venture or collaboration or
marketing/distribution or such other formal arrangement providing the third
party company the right to co-manufacture, co-develop, co-promote or co-market
Licensed Products in the Licensed Field in conjunction with Licensee.
ARTICLE II -- THE GRANT
2.1 UIRF hereby grants to Licensee and its Affiliates, subject to the terms and
conditions hereof, a non-exclusive license under Licensed Patents to make, have
made, use, import, sell, offer to sell and have sold the Licensed Products
within the Licensed Field in the Licensed Territory.
2.2 The license granted in Section 2.1 above extends to a Partner as defined in
Section 1.10 only to the extent that said license is limited to the Partner's
right to manufacture, use, sell and import Licensed Products within the Licensed
Field in conjunction with Licensee. Within thirty (30) days of the execution of
this Agreement, or in the case of Licensee's new Partner Agreements, within
thirty (30) days of the execution of the Partner Agreement, Licensee shall
notify its Partner(s) that this License grants to the Partner only limited
rights under the Licensed Patent for the Licensed Field and that the Partner
will need a separate license from the UIRF for the Partner's use, manufacture or
sale of any additional products which are not made in conjunction with Licensee.
Licensee shall promptly send copies to UIRF of all such notifications sent to
such Partners, specifying the Licensed Products that are the subject of the
agreement between Licensee and the Partner.
Since (a) the UIRF has granted a number of non-exclusive licenses to the
Licensed Patents and (b) there exist several inter-relationships among UIRF's
licensees and licensees' affiliates, the Partners of Licensee may already have
enabling licenses for the Licensed Patents within the Licensed Field.
Additionally, since UIRF will get delayed notification of the nature of the
relationship between Licensee and its Partner, UIRF cannot be the party
determining whether any of Licensee's Partners have such enabling licenses
already. The UIRF will not intentionally collect any double payments; however,
all payments made to UIRF are non-refundable and UIRF shall not be held
responsible for any double payments that are made by Licensee and/or its
Partners.
ARTICLE III -- PAYMENTS, REPORTS, RECORD-KEEPING
3.1 In consideration of the rights granted to Licensee pursuant to Article II of
this Agreement, Licensee agrees to make the following payments to the UIRF :
(a) A non-refundable payment ("License Fee") of [**] dollars ($[**]) immediately
upon execution of this Agreement.
(b) Earned Royalties in an amount equal to [**] percent ([**]%) of the Net Sales
of Licensed Products to be paid on a quarterly basis.
(c) A payment of [**] dollars ($[**]) for each of the first four Licensed
Products to successfully complete Phase I FDA trials. Such payment shall accrue
for each Licensed Product upon approval by FDA for the product to proceed to
Phase II FDA trials and shall be payable within thirty (30) days of accrual.
This payment would accrue and be payable regardless of the date of execution of
this Agreement. If such milestone event has occurred and associated payment has
accrued prior to the execution of this Agreement, Licensee shall pay such
amount(s) immediately to UIRF upon execution of this Agreement
(d) A payment of [**] dollars ($[**]) for each of the first four Licensed
Products to successfully complete Phase II FDA trials. Such payment for each
Licensed Product shall accrue upon approval by FDA for the product to proceed to
Phase III FDA trials and shall be payable within thirty (30) days of accrual.
This payment would accrue and be payable regardless of the date of execution of
this Agreement. If such milestone event has occurred and associated payment has
accrued prior to the execution of this Agreement, Licensee shall pay such
amount(s) immediately to UIRF upon execution of this Agreement.
(e) A payment of [**] dollars ($[**]) for each of the first four (4) Licensed
Products to receive FDA approval for marketing in the United States. Such a
payment for each Licensed Product shall accrue upon receipt of FDA approval for
the product and shall be payable within thirty (30) days of accrual. This
payment would accrue and be payable regardless of the date of execution of this
Agreement. If such milestone event has occurred and associated payment has
accrued prior to the execution of this Agreement, Licensee shall pay such
amount(s) immediately to UIRF upon execution of this Agreement.
(f) An annual payment ("License Maintenance Fee") of thirty - five thousand
dollars ($35,000), beginning on the one-year anniversary of the Effective Date
and continuing annually on each anniversary of the Effective Date. The License
Maintenance Fee is not due on any anniversary of this Agreement if on that date
Licensee is commercially selling Licensed Product and paying an earned royalty
to UIRF on the sales of that Licensed Product.
3.2 Licensee agrees to submit to UIRF within sixty (60) days after December 31,
March 31, June 30 and September 30 of each calendar year, reports setting forth
for the preceding three (3) month reporting period, the Net Sales of Licensed
Products and royalty due thereon and with each such royalty report to pay the
amount of royalty due. Each such royalty report will cover Licensee's most
recently completed calendar quarter and will show:
(a) The gross sales and Net Sales of Licensed Products sold during the most
recently completed calendar quarter;
(b) The name and number of each type of Licensed Product sold;
(c) The royalties, in U.S. dollars, payable with respect to sales of Licensed
Products;
(d) The method used to calculate the royalty; and
(e) The exchange rates used, if applicable.
3.3 If no sales of Licensed Products have been made during any reporting period,
a statement to this effect is required.
3.4 It is anticipated that Licensee may supply Licensed Products to an
Affiliate, Partner or to another licensee of UIRF for further processing and/or
sale by such Affiliate, Partner or other licensee of UIRF under Licensed
Patents. UIRF will accept royalties on Licensed Product(s) under this Agreement
directly from Licensee or such Affiliate, Partner or other licensee of UIRF upon
receipt of appropriate notification from Licensee and such Affiliate, Partner or
other
licensee of UIRF. However, absent such notification to UIRF, Licensee shall bear
the responsibility for the payment of royalties on such Licensed Product(s).
3.5 In the event that Licensee becomes obligated at any time or from time to
time during the term of this Agreement to pay royalties to any third party for
the practice of any method or use of any composition of matter covered by any
claim of the Licensed Patents or for the sale of any Licensed Products,
Licensee's royalty obligation to the UIRF shall be reduced by an amount equal to
its royalty obligation to such third party; provided, however, that Licensee's
royalty obligation shall not be reduced by more than fifty percent (50%) for any
one calendar quarter.
3.6 Licensee's obligation to pay royalties on Licensed Product(s) hereunder
shall be suspended during any period of time that Licensee is enjoined, or
reasonably believes it may be enjoined, from exercising any of its rights
hereunder with respect to the Licensed Patents or any such Licensed Product(s).
Upon resolution of any such matter, Licensee shall promptly pay to UIRF all
amounts previously withheld with respect to such matter, less any reduction
which may be applicable pursuant to Section 3.5 above, provided, however, that
Licensee's royalty obligation shall not be reduced by more than fifty percent
(50%) for any one calendar quarter.
3.7 Licensee shall report, not any less frequently than annually, on its efforts
and progress made towards commercialization of any products involving Licensed
Patents. Licensee agrees to notify UIRF promptly, in writing, of the date of the
first commercial sale of a Licensed Product to an end user.
3.8 Licensee shall keep complete, true and accurate books of account and records
of Licensed Products made, used and/or sold under this Agreement for the purpose
of showing the derivation of all amounts payable to UIRF under this Agreement.
Said books and records shall be kept at Licensee's principal place of business
for at least five (5) years following the end of a reporting period to which
they pertain. UIRF is hereby granted by Licensee the right, upon reasonable
written notice to Licensee, to retain an independent certified public accountant
reasonably acceptable to Licensee and appropriately bound by confidentiality, to
audit Licensee's records solely to verify sales of the Licensed Products. The
UIRF shall bear the fees and expenses of such audit, but if an error in
royalties of more than five percent (5%) of the total royalties due for any year
is discovered in any audit, then Licensee shall bear the fees and expenses of
that audit.
3.9 All payments due hereunder shall be payable in United States dollars.
Conversion of foreign currency to U.S. dollars shall be made at the conversion
rate existing in the United States as reported in The Wall Street Journal on the
last working day of each royalty period. Such payments shall be without
deduction of exchange, collection or other charges.
3.10 In the event payments or fees are not received by UIRF when due, Licensee
shall pay to UIRF interest charges at a rate of one and one half percent (1.5%)
per month. Such interest is calculated from the date the payment was due until
actually received by UIRF.
3.11 No royalties may be collected or paid on Licensed Products sold to the
account of the U.S. Government, any agency thereof, state or domestic municipal
government as provided for under 35 U.S.C. Section 200-212 and applicable
regulations.
ARTICLE IV -- TERM AND TERMINATION
4.1 Unless terminated earlier in accordance with this Agreement, the term of
this Agreement shall be until the expiration of the last to expire of the
Licensed Patents or until the Licensed Patents are held invalid or unenforceable
by a court or tribunal from which no appeal can be taken.
4.2 In the event Licensee fails to make payments due hereunder, UIRF shall have
the right to terminate this Agreement upon ninety (90) days written notice,
unless Licensee makes such payments plus interest within the ninety (90) day
notice period.
4.3 In the event that Licensee shall become insolvent, shall make an assignment
for the benefit of its creditors, or shall have a petition in bankruptcy filed
for or against it and such petition shall not have been discharged within ninety
(90) days, UIRF may, at its option, terminate this license upon thirty (30) days
written notice.
4.4 Licensee shall have the right to terminate this Agreement at any time by
written notice to UIRF to that effect. Licensee shall have the right during a
period of six (6) months following the effective date of such termination to
sell or otherwise dispose of the Licensed Products existing at the time of such
termination, and shall make a final report and payment of all royalties related
thereto within sixty (60) days following the end of such period or the date of
the final disposition of such inventory, whichever first occurs.
4.5 Licensee agrees to retain records subsequent to the termination of this
Agreement under Section 4.1 and to make sales reports to UIRF even after
Licensed Patents have expired for the sole purpose of assuring UIRF that all
products construed as Licensed Products under prevailing patent law and any
associated obligations under this Agreement are and have been met. Concurrent
with the submittal of each post-termination report, Company shall pay UIRF all
applicable royalties. This obligation shall cease at the end of the reporting
period following the sale or destruction of the last Licensed Product.
4.6 Any termination of this Agreement will not affect the rights and obligations
set forth in the following Articles: 3.8, 4.4, 4.5, 6.1, 6.2, 7.5 and 7.6.
ARTICLE V -- ASSIGNMENT
5.1 This Agreement may be assigned by Licensee as part of a transfer of all, or
substantially all, of the business to which this Agreement relates. This
Agreement shall be binding upon and inure to the benefit of successors in
interest and assigns of Licensee. Licensee agrees to inform UIRF of such
transfer promptly.
ARTICLE VI -- REPRESENTATIONS: LIMITATIONS
6.1 Nothing in this Agreement shall be construed as:
(a) a warranty or representation by UIRF as to the validity or scope of any
Licensed Patents; or
(b) a warranty or representation that anything made, used, sold or otherwise
commercialized under the license granted in this Agreement is or will be free
from infringement of patents owned by third parties; or
(c) conferring a right to use in advertising, publicity or otherwise the name of
the University of Iowa ("UI") or UIRF, unless UIRF has specifically approved the
same in writing; or
(d) conferring by implication, estoppel or otherwise any license or rights under
any patents of the UIRF/UI other than Licensed Patents, regardless of whether
such patents are dominant or subordinate to Licensed Patents (however, UIRF is
not aware of any UIRF patent or application dominant to Licensed Patents); or
(e) an obligation to furnish any know-how not provided in Licensed Patents.
6.2 UIRF expressly disclaims any and all implied or express warranties and makes
no express or implied warranties of merchantability or fitness for any
particular purpose of the Licensed Patents, biological materials or processes or
Licensed Products contemplated by this Agreement.
6.3 Licensee warrants that prior to the Effective Date of this Agreement, there
have been no commercial sales of products which would be characterized as
Licensed Products had this Agreement been in force at the time of such
commercial sales.
ARTICLE VII -- GENERAL
7.1 Licensee shall not distribute or resell the Licensed Products to others
except in accordance with this Agreement. Licensee agrees to comply with all
applicable laws and regulations.
7.2 UIRF shall have the responsibility for the prosecution, filing and
maintenance of all Licensed Patents, including the conduct of all interference,
opposition, nullity and revocation proceedings, as well as responsibility for
all fees and costs associated therewith.
7.3 UIRF shall have the right but not the obligation at its expense to initiate
any proceeding relating to any infringement by a third party of any Licensed
Patents in the Licensed Field. In the event the UIRF decides not to initiate a
proceeding relating to infringement by a third party, the UIRF agrees to inform
Licensee of its rationale for not filing a proceeding, and further agrees to
consider Licensee's comments thereto.
7.4 UIRF shall have no obligation to defend any action for infringement brought
against Licensee by a third party.
7.5 The relationship between UIRF and Licensee shall be that of independent
contractors. UIRF and Licensee shall have no other relationship other than as
independent contracting parties. Neither party is authorized or empowered to act
as agent for the other for any purpose and shall not on behalf of the other
enter into any contract, warranty, or representation as to any matter. Neither
shall be bound to the acts or conduct of the other.
7.6 Licensee shall indemnify and hold harmless UIRF and UI and their employees,
officers, agents, consultants and their respective successors, heirs and
assigns, from any action, claim or liability, including, without limitation,
liability for death, personal injury, or property damages arising directly or
indirectly from Licensee's possession, distribution or other use of Licensed
Products under this Agreement and/or from Licensee's publication or distribution
of test reports, data and other information relating to Licensed Products.
7.7 If any provision of this Agreement is held to be invalid, illegal or
unenforceable in any respect, that invalidity, illegality or unenforceability
will not affect any other provisions of this Agreement, and this Agreement will
be construed as if the invalid, illegal or unenforceable provisions had never
been contained in it.
7.8 Neither party may waive or release any of its rights or interests in this
Agreement except in writing. Any delay or failure to assert any right arising
from this Agreement shall not be deemed or construed to be a waiver of such
right.
7.9 The headings of the several sections are inserted for convenience of
reference only and are not intended to be a part of or to affect the meaning or
interpretation of this Agreement.
ARTICLE VIII -- MARKING
8.1 Licensee agrees to comply with marking provisions of Title 35, U.S. Code,
Section 287, if required, or any future equivalent provisions of the United
States relating to the marking of patented devices, or with marking complying
with the law of the country where the Licensed Products are shipped, used or
sold when such marking is required to preserve patent rights.
ARTICLE IX -- NOTICES; APPLICABLE LAW
9.1 Any notice, report or payment provided for in this Agreement shall be deemed
sufficiently given when sent by facsimile or regular, certified or registered
mail addressed to the party for whom intended at the following addresses, or to
such address as either party may hereafter designate in writing to the other:
For UIRF:
University of Iowa Research Foundation,
Xxxxxx X. Xxxxx, Associate Director
000 Xxxxxxxxxx Xxxxxxxxxx Xxxxxx
Xxxx Xxxx, XX 00000-0000
Phone: 000-000-0000
Fax: 000-000-0000
For Licensee:
-----------------------------------------
-----------------------------------------
9.2 This agreement shall be construed, interpreted, and applied in accordance
with the laws of the State of Iowa.
ARTICLE X -- INTEGRATION
10.1 This Agreement constitutes the entire agreement between the parties
relating to the subject matter thereof, and all prior negotiations,
representations, agreements and understandings are merged into, extinguished by,
and completely expressed by it. This Agreement cannot be changed or terminated
orally, but only in writing and if signed by both parties. This Agreement shall
be binding on the heirs, successors, and assigns of the parties hereto.
IN WITNESS WHEREOF, both the UIRF and Licensee have executed this Agreement by
their respective and duly authorized officers on the day and year written. This
Agreement is effective as of the Effective Date.
LICENSOR LICENSEE
University of Iowa Research Foundation BioVex Ltd.
By: /s/ W. Xxxxx Xxxxxxx By: /s/ Xxxxxx Xxxxxx
---------------------------------- -----------------------------------
Date: Date:
-------------------------------- ---------------------------------
Name: W. Xxxxx Xxxxxxx Name: Xxxxxx Xxxxxx
Title: Executive Director Title: Director
