1
Redacted Version
AGREEMENT
BY AND BETWEEN
RGENE THERAPEUTICS, INC.
AND
LABORATOIRES FOURNIER S.C.A.
DATED AS OF MAY 28, 1996
[*] = omitted, confidential material, which material has been separately
filed with the Securities and Exchange Commission pursuant to a request for
confidential treatment.
2
Redacted Version
TABLE OF CONTENTS
1.0 Definitions ....................................................... 2
2.0 License Grant ..................................................... 8
3.0 FOURNIER Due Diligence ............................................ 9
4.0 Regulatory Approval ............................................... 10
5.0 Manufacturing ..................................................... 13
6.0 Payments And Royalties ............................................ 20
7.0 Improvements ...................................................... 23
8.0 Confidentiality ................................................... 24
9.0 Enforcement ....................................................... 26
10.0 Patents and Inventions ............................................ 30
11.0 Term .............................................................. 30
12.0 Assignment ........................................................ 32
13.0 Indemnity ......................................................... 32
14.0 Miscellaneous Provisions .......................................... 33
15.0 Representations and Warranties .................................... 36
3
AGREEMENT
This Agreement ("AGREEMENT"), effective as of the 28th day of May, 1996, is
entered into by and between RGENE Therapeutics, Inc., a corporation organized
under the laws of the State of Delaware and having its principal place of
business at 2170 Buckthorne Place, #230, The Woodlands, Texas 77380, U.S.A.
(hereinafter "RGENE"), and Laboratoires Fournier S.C.A., a corporation organized
under the laws of France and having its principal place of business at 42 rue de
Longvic, 21300 Chenove, France (hereinafter "FOURNIER").
WHEREAS, the Board of Regents (hereinafter the "BOARD") of The University
of Texas System is the owner of certain patent and technology rights relating to
E1A subject matter disclosed and/or claimed in European Patent Application No.
EP 92 90 2782.9 for "Method and Compositions for the Suppression of neu Mediated
Transformation" and International Patent Application PCT/US94/13868.
WHEREAS, the BOARD, through an agreement effective as of March 1, 1994,
granted RGENE an exclusive, world-wide license to the E1A subject matter with
the right to grant sublicenses consistent with the March 1, 1994 agreement.
WHEREAS, The University of Tennessee Research Corporation (hereinafter
"UTRC") and McMaster University (hereinafter "McMaster") jointly own certain
patent and technology rights to the cationic lipid subject matter disclosed
and/or claimed in European Patent Application No. EP 92 92 0321.4.
WHEREAS, UTRC has the exclusive right to commercialize the cationic lipid
subject matter, including the right to grant licenses to any PERSON (as defined
below), through an agreement entered into between UTRC and McMaster effective as
of May 25, 1992.
WHEREAS, UTRC has granted RGENE exclusive rights with respect to the
LICENSED FIELDS (as defined below), including the right to sublicense such
rights to any PERSON, through an agreement effective October 12, 1995, as
amended by the First Amended and Restated License Agreement Between The
University of Tennessee Research Corporation and RGENE Therapeutics, Inc.
executed by UTRC and RGENE on December 6, 1995 and December 8, 1995,
respectively.
WHEREAS, Argus Pharmaceuticals, Inc. (now known as Aronex Pharmaceuticals,
Inc.) obtained certain rights to UTRC's cationic lipid subject matter
4
from UTRC under an agreement dated November 1, 1993 with the right to sublicense
such technology to any PERSON.
WHEREAS, Argus Pharmaceuticals, Inc. granted RGENE an exclusive license
with respect to UTRC's rights to the cationic lipid subject matter by an
agreement entered into between Argus Pharmaceuticals, Inc. and RGENE effective
as of April 6, 1994.
WHEREAS, FOURNIER desires to obtain the right to use, develop, have
developed, market, have marketed, sell, or have sold, and a limited right to
make or have made, LICENSED E1A PRODUCTS in the LICENSED TERRITORY (as those
terms are defined below).
NOW, THEREFORE, in consideration of the premises, the mutual covenants
recited herein, and other good and valuable consideration, the receipt and
sufficiency of which are hereby acknowledged, it is hereby agreed as follows:
1.0 DEFINITIONS
For the purposes of this AGREEMENT, the following terms shall have the
meanings indicated (such meanings to be equally applicable to both the singular
and plural forms of the terms defined).
1.01 (A) AFFILIATE shall mean, with respect to any PERSON, any other
PERSON which, directly or indirectly, controls, is controlled by, or is under
common control with such PERSON or any AFFILIATE of such PERSON pertaining to
the subject matter of this AGREEMENT. "Control" shall mean ownership of fifty
percent (50%) or more of the issued share capital or the legal power to cause
the direction of the general management and policies of the entity in question.
(B) PERSON shall mean any individual, sole proprietorship,
partnership, joint venture, trust, unincorporated organization, association,
corporation, institution, public benefit corporation, firm, joint stock company,
estate, entity, or GOVERNMENTAL AUTHORITY.
1.02 AFFILIATE SUBLICENSE shall mean a sublicense granted by FOURNIER
under this AGREEMENT to an AFFILIATE of FOURNIER. AFFILIATE SUBLICENSEE shall
mean any sublicensee of FOURNIER under this AGREEMENT who is an AFFILIATE of
FOURNIER.
1.03 ASSOCIATE SUBLICENSE shall mean a sublicense granted by FOURNIER
under this AGREEMENT that provides for FOURNIER to receive as consideration
anything of value in lieu of money. ASSOCIATE SUBLICENSEE shall
-2-
5
mean any sublicensee of FOURNIER under an ASSOCIATE SUBLICENSE. Notwithstanding
the foregoing, if a sublicensee qualifies as both an AFFILIATE SUBLICENSEE and
an ASSOCIATE SUBLICENSEE, such sublicensee shall be deemed an AFFILIATE
SUBLICENSEE for all purposes, and the sublicense granted to such sublicensee
shall be considered an AFFILIATE SUBLICENSE.
1.04 DEVELOPMENT COMMITTEE shall mean a joint committee of PERSONS
appointed by each of RGENE and FOURNIER, which committee shall recommend
guidelines and strategy for developing and improving the LICENSED E1A PRODUCT in
the LICENSED TERRITORY and the United States. RGENE and FOURNIER shall each be
entitled to appoint three (3) PERSONS to the DEVELOPMENT COMMITTEE. THE
DEVELOPMENT COMMITTEE shall be established within sixty (60) days after the
effective date of this AGREEMENT, and may make non-binding recommendations
concerning the strategy for developing and improving the LICENSED E1A PRODUCT in
the LICENSED TERRITORY and the United States.
1.05 LICENSED E1A SUBJECT MATTER shall mean any inventions disclosed
and/or claimed, and related LICENSED TECHNOLOGY and LICENSED PATENT RIGHTS,
relating to the tumor suppressor E1A gene described in European Patent
Application No. EP 92 90 2782.9, and International Patent Application
PCT/US94/13868, and IMPROVEMENTS thereto subject to Sections 7.01 and 7.02
hereof.
1.06 LICENSED CATIONIC LIPID SUBJECT MATTER shall mean any inventions
disclosed and/or claimed, and related LICENSED TECHNOLOGY and LICENSED PATENT
RIGHTS, relating to the cationic lipid subject matter described in European
Patent Application No. EP 92 92 0321.4, and IMPROVEMENTS thereto subject to
Sections 7.01 and 7.02 hereof.
1.07 LICENSED E1A PRODUCT shall mean any method, product or
composition, any part of which comprises LICENSED E1A SUBJECT MATTER with or
without the LICENSED CATIONIC LIPID SUBJECT MATTER.
1.08 LICENSED FIELD shall mean: (A) with respect the LICENSED E1A
SUBJECT MATTER, any method, product or composition and fields of use of the
LICENSED E1A SUBJECT MATTER, including all human and veterinary therapeutics,
prophylactic, and diagnostic applications of the LICENSED E1A SUBJECT MATTER;
and (B) with respect to the LICENSED CATIONIC LIPID SUBJECT MATTER, use of the
LICENSED CATIONIC LIPID SUBJECT MATTER
-3-
6
in combination with the LICENSED E1A PRODUCT for therapeutic and prophylactic
applications of the LICENSED E1A SUBJECT MATTER for all cancers, [*]. LICENSED
FIELD shall be extended to include the excluded cancers if and when RGENE
obtains a license to such cancers which RGENE has the right to sublicense. The
sale for research purposes of cationic lipid(s), reagent(s), and/or other
products based upon or incorporating the LICENSED CATIONIC LIPID SUBJECT MATTER
shall also be excluded from the LICENSED FIELD. RGENE shall use its best
good-faith efforts that are commercially reasonable to have the excluded cancers
included within the LICENSED FIELD, and shall promptly notify FOURNIER in
writing as soon as RGENE has obtained the rights necessary to include the
excluded cancers within the LICENSED FIELD. Any cost or expense necessary to
include such excluded cancers in the LICENSED FIELD shall be borne solely by
RGENE.
1.09 LICENSED TERRITORY shall mean the countries set forth in Appendix
A hereto.
1.10 LICENSED PATENT RIGHTS shall mean the inventions described and
claimed in European Patent Application Nos. EP 92 90 2782.9 and EP 92 92 0321.4,
and International Patent Application PCT/US94/13868, together with any
divisions, continuations, substitution or other applications based thereon, any
patents issuing thereon or extensions thereof, any and all counterparts
corresponding thereto listed in Appendix B hereto, including foreign counterpart
patent applications, issued foreign patents and amendments thereto, in the
LICENSED TERRITORY, which claim priority from, establishes the priority claim
for, or shares a common priority claim with, either European Patent Application
No. EP 92 90 2782.9, European Patent Application No. EP 92 92 0321.4 or the
International Patent Application PCT/US94/13868, and any and all IMPROVEMENTS
subject to Sections 7.01 and 7.02 hereof.
1.11 LICENSED TECHNOLOGY shall mean any unpatented technical
information or know-how now existing or developed during the term of this
AGREEMENT relating to either LICENSED E1A SUBJECT MATTER or the LICENSED
CATIONIC LIPID SUBJECT MATTER for use with the LICENSED E1A SUBJECT MATTER,
including the technical information in all current and future patent
applications, regulatory submissions to GOVERNMENTAL AUTHORITIES for the
purposes of obtaining marketing approval, manuals, formulas, specifications,
test data and procedures, flow charts, apparatus plans, papers, software,
drawings, laboratory notebooks, and other information.
- --------
* Confidential Treatment Requested
-4-
7
1.12 (A) IMPROVEMENT shall mean all developments in the LICENSED
PATENT RIGHTS or LICENSED TECHNOLOGY conceived or reduced to practice prior to
any termination of this AGREEMENT, including any delivery system to which RGENE
has access, whether or not patentable, which are invented, developed, or
discovered relating to the LICENSED E1A SUBJECT MATTER or the LICENSED CATIONIC
LIPID SUBJECT MATTER to the extent such IMPROVEMENT in the LICENSED CATIONIC
LIPID SUBJECT MATTER is for use with the LICENSED E1A SUBJECT MATTER.
(B) IMPROVEMENTS in which the BOARD has rights shall be treated
as any other IMPROVEMENT under this AGREEMENT, except as specifically set forth
in Article 7.0 hereof and shall include any inventions and discoveries which are
IMPROVEMENTS under this AGREEMENT and are within the scope of either (i) the
BOARD's pending applications, issued patents, and/or patent applications,
whether domestic or foreign, and all divisionals, continuations,
continuation-in-part, reissue, reexaminations or extensions thereof, and any
letters patent that issue therefrom for the inventions disclosed in European
Patent Application No. EP 92 90 2782.9 and International Patent Application
PCT/US94/13868 or (ii) technology sponsored by RGENE under the supervision of
Mien-Chie Hung, Ph.D., and developed in the Labatoires of either Mien-Chie Hung,
Ph.D. or Gabriel Lopez-Berestein, M.D. at The University of Texas M.D. Anderson
Cancer Center.
1.13 NET SALES shall mean the sale of any LICENSED E1A PRODUCT by:
(A) FOURNIER to a PERSON other than an AFFILIATE. If any separate
consideration payable wholly in money, then NET SALES shall mean the aggregate
gross selling price of such LICENSED E1A PRODUCT in the form in which such
LICENSED E1A PRODUCT is sold, whether or not such LICENSED E1A PRODUCT is in
final form (and without excluding therefrom any components or subassemblies
thereof, whatever their origin). The distribution of free samples of LICENSED
E1A PRODUCT by FOURNIER shall not exceed the normal practice of FOURNIER for its
other products;
(B) FOURNIER for consideration other than money. If any LICENSED
E1A PRODUCT is sold for other than separate consideration payable wholly in
money, then NET SALES shall be determined in good faith by FOURNIER by assuming
that FOURNIER received the same NET SALES (as defined in Section 1.13(A) hereof)
that would have been realized in a transaction with an unaffiliated buyer in an
arm's length sale of such LICENSED E1A PRODUCT for money; and
-5-
8
(C) any AFFILIATE SUBLICENSEE or ASSOCIATE SUBLICENSEE. If any
LICENSED E1A PRODUCT is sold by any AFFILIATE, then such sale shall be
considered a sale by FOURNIER.
(D) NET SALES shall reflect the following deductions:
(i) usual and customary trade discounts and rebates actually
given;
(ii) customary credits for claims, allowances, retroactive
price reductions, returns, refunds, and recalls;
(iii) charges for packaging, transportation, handling, and
insurance actually paid in connection with the LICENSED E1A PRODUCT; and
(iv) taxes, duties, customs, tariffs, and other charges or
assessments imposed by GOVERNMENTAL AUTHORITIES and actually paid in connection
with the LICENSED E1A PRODUCT.
(E) In the event the LICENSED E1A PRODUCT is sold as a
combination product containing one or more active components in addition to such
LICENSED E1A PRODUCT, then NET SALES for such combination product shall be
calculated by multiplying such NET SALES by the fraction A/(A+B), where A is the
invoice price of the LICENSED E1A PRODUCT if sold separately and B is the total
invoice price of any other active component(s) in the combination if sold
separately by FOURNIER or an AFFILIATE. If the other active component or
components in the combination are not sold separately by FOURNIER or an
AFFILIATE of FOURNIER, NET SALES for the combination product shall be calculated
by multiplying NET SALES of the combination by the fraction C/(C +D), where C is
FOURNIER's or such AFFILIATE's total actual cost of the LICENSED E1A PRODUCT at
the point of formulation into the combination product and D is FOURNIER's or
such AFFILIATE's total actual cost of the other active component(s) included in
the combination product.
1.14 PARTY shall mean either RGENE or FOURNIER. PARTIES shall mean
RGENE and FOURNIER.
1.15 FISCAL YEAR shall mean the period from January 1 through December
31.
1.16 PROPOSING PARTY shall have the meaning set forth in Section 7.04
hereof.
-6-
9
1.17 NON-PROPOSING PARTY shall have the meaning set forth in Section
7.04 hereof.
1.18 SUPPLY AGREEMENT shall have the meaning set forth in Section 5.01
hereof.
1.19 CONFIDENTIAL INFORMATION shall have the meaning set forth in
Section 8.01 hereof.
1.20 DEVELOPMENT PLAN shall mean the plan made or agreed to by the
DEVELOPMENT COMMITTEE, and any amendment thereto or modification thereof made or
agreed to by the PARTIES, which plan in all cases shall not be binding upon the
PARTIES.
1.21 EMEA shall mean the European Medicines Evaluation Agency or any
successor agency.
1.22 FDA shall mean the United States Food and Drug Administration or
any successor agency.
1.23 GOVERNMENTAL AUTHORITY shall mean any federal, national, state,
county or local governmental authority or quasi-governmental authority of the
United States or any country within the LICENSED TERRITORY, or any subdivision,
commission, department, branch, instrumentality, agency, or court thereof,
including, without limitation, the FDA and the EMEA.
1.24 ND shall mean any application made to the FDA or any other
applicable GOVERNMENTAL AUTHORITY, seeking permission to test any LICENSED E1A
PRODUCT.
1.25 LICENSORS shall mean the BOARD, UTRC, McMaster, and Aronex
Pharmaceuticals, Inc., or any of them.
1.26 NDA shall mean any application made to the FDA or any other
applicable GOVERNMENTAL AUTHORITY, seeking permission to market any LICENSED E1A
PRODUCT.
1.27 PLA shall mean any application made to the FDA or any other
applicable GOVERNMENTAL AUTHORITY, seeking permission to license any LICENSED
E1A PRODUCT.
1.28 TRANSFER PRICE shall have the meaning set forth in Section 5.03(A)
hereof. AGGREGATE TRANSFER PRICE shall mean the amount equal to
-7-
10
the TRANSFER PRICE multiplied by the number of units of LICENSED E1A PRODUCT
purchased or sold during a calendar quarter or FISCAL YEAR, as the case may be.
2.0 LICENSE GRANT
2.01 During the term of this AGREEMENT, RGENE hereby grants to
FOURNIER, and FOURNIER hereby accepts, the exclusive right and license to use,
develop, have developed, market, have marketed, sell, or have sold the LICENSED
E1A PRODUCT in the LICENSED TERRITORY in the LICENSED FIELD upon the terms and
conditions set forth in this AGREEMENT, and further subject to the royalty-free,
non-exclusive and other rights held by the United States Government. RGENE also
grants FOURNIER a limited right to make and have made the LICENSED E1A PRODUCT
subject to the terms and conditions set forth in Sections 2.03 and 5.07 hereof.
2.02 Right To Sublicense
(A) FOURNIER shall have the right to sublicense or co-promote
the license to any PERSON, subject to RGENE's approval (which approval shall not
be unreasonably withheld by RGENE) and RGENE's underlying licenses from the
LICENSORS. In the event that FOURNIER exercises its right to sublicense pursuant
to this Section 2.02, FOURNIER acknowledges and agrees that: (i) such sublicense
shall not relieve FOURNIER of any of its obligations under this AGREEMENT; (ii)
subject to Section 11.02 hereof, any act or omission of a sublicensee of
FOURNIER that would constitute a breach of this AGREEMENT if such act or
omission had been taken or omitted by FOURNIER shall be considered an act or
omission of FOURNIER; and (iii) no sublicense agreement shall expand or amend
FOURNIER's rights or obligations under this AGREEMENT.
(B) FOURNIER shall deliver to RGENE a true and correct copy of
each sublicense agreement prior to execution by FOURNIER, a copy of the executed
agreement, and any modification or termination thereof (excluding in each of the
foregoing cases all financial terms contained therein), within thirty (30) days
after such execution, modification, or termination.
2.03 Limited Right To Manufacture LICENSED E1A PRODUCT
(A) RGENE shall use its best efforts to revise its license
agreements covering the LICENSED E1A PRODUCT to provide for FOURNIER to become
the direct licensee of the LICENSED E1A PRODUCT in the LICENSED TERRITORY in the
event RGENE's rights under any of the license agreements are
-8-
11
terminated. If the applicable license rights granted to RGENE by the LICENSORS
are terminated, then FOURNIER shall have the right to develop, produce,
manufacture, and market the LICENSED E1A PRODUCT in the LICENSED TERRITORY in
accordance with the terms of agreements FOURNIER has reached with the BOARD and
UTRC. Acceptance of FOURNIER to become a direct licensee of the LICENSORS shall
be as set forth in the letters from the LICENSORS dated May 22, 1996 and May 23,
1996, copies of which are attached hereto as Appendix E.
(B) FOURNIER shall have a right to cure any default of RGENE that
might cause any termination of RGENE's license rights from the LICENSORS.
2.04 FOURNIER shall have the right to transfer the license granted
pursuant to, and its rights and obligations under, this AGREEMENT: (i) as
permitted by Section 2.02(A) hereof; (ii) to an AFFILIATE of FOURNIER; or (iii)
in connection with the sale of all or substantially all of the business of
FOURNIER or the sale of such business to which this AGREEMENT relates.
2.05 RGENE makes no warranties that the LICENSED PATENT RIGHTS will
prevent all PERSONS from marketing product(s) in the LICENSED TERRITORY in the
LICENSED FIELD which would compete with the LICENSED E1A PRODUCT. Such
occurrence shall not constitute a breach by RGENE of this AGREEMENT, and, in
such case, FOURNIER shall not have any claim for damages under this AGREEMENT
against RGENE, the BOARD or UTRC; provided, however, that in the event of such
occurrence, the PARTIES shall promptly meet and negotiate in good faith any
appropriate changes to this AGREEMENT in accordance with Section 9.05 hereof.
2.06 FOURNIER shall not utilize the LICENSED TECHNOLOGY or the
LICENSED PATENT RIGHTS for any purpose other than that encompassed by the
license granted under this AGREEMENT.
3.0 FOURNIER DUE DILIGENCE
3.01 FOURNIER shall use its best good-faith efforts that are
commercially reasonable in conducting clinical trials, obtaining regulatory
approval, and marketing the LICENSED E1A PRODUCT in the LICENSED TERRITORY.
3.02 FOURNIER shall use its best good-faith efforts that are
commercially reasonable to bring one or more LICENSED E1A PRODUCTS to market in
the LICENSED FIELD in the LICENSED TERRITORY. If RGENE, in good faith,
reasonably believes that a market for the LICENSED E1A PRODUCT in
-9-
12
the LICENSED TERRITORY and/or LICENSED FIELD is not being adequately penetrated
by FOURNIER (or its AFFILIATES or sublicensees), then RGENE shall notify
FOURNIER in writing as to this belief. The PARTIES shall then meet expeditiously
and discuss measures to revise, if necessary, FOURNIER's marketing strategy. If
the PARTIES mutually agree that a revision to FOURNIER's marketing strategy is
required, then FOURNIER shall cooperate with RGENE to develop a revised
marketing strategy that is commercially reasonable using best good-faith
efforts. Subject to this Section 3.02 and Section 3.01 hereof, FOURNIER shall
implement any such revised marketing strategy.
4.0 REGULATORY APPROVAL
4.01 FOURNIER Obligations
(A) FOURNIER shall be responsible for diligently pursuing
regulatory approval of the LICENSED E1A PRODUCT by GOVERNMENTAL AUTHORITIES in
the LICENSED TERRITORY.
(B) FOURNIER shall be responsible for conducting the clinical
development of the LICENSED E1A PRODUCT in the LICENSED TERRITORY and funding
all clinical trials in the LICENSED TERRITORY for the LICENSED E1A PRODUCT.
FOURNIER shall use its best good-faith efforts that are commercially reasonable
to diligently pursue the clinical trials in the LICENSED TERRITORY.
(C) FOURNIER shall be responsible for preparation of the EMEA
regulatory approval file.
(D) If FOURNIER fails to fulfill its obligations under Section
4.01(B) hereof for a period of six (6) months without good cause, then, after
the notice provisions of this AGREEMENT have been satisfied, in addition to any
remedies available to RGENE for breach, RGENE's obligations as set forth in
Section 4.03(C) hereof shall cease.
4.02 RGENE Obligations
(A) RGENE and any sublicensee shall use their best good-faith
efforts that are commercially reasonable in obtaining all requisite approvals of
the LICENSED E1A PRODUCT by GOVERNMENTAL AUTHORITIES in the United States,
including, without limitation, conducting the clinical trials required to be
conducted in the United States.
-10-
13
(B) If RGENE sublicenses the development rights to the LICENSED
E1A PRODUCT in the United States, then RGENE's sublicensees shall (i) comply
with the applicable terms and conditions of this AGREEMENT, including, without
limitation, Sections 4.02(A) and 4.03 hereof, and (ii) use their best good-faith
efforts that are commercially reasonable to develop and market the LICENSED E1A
PRODUCT. Nothing contained in a sublicense agreement between RGENE and a
sublicensee shall diminish the obligations of RGENE or the rights of FOURNIER
under this AGREEMENT.
(C) If RGENE or its sublicensees fail to fulfill the obligations
under Section 4.02(A) or 4.02(B) hereof for a period of six (6) months without
good cause, then, after the notice provisions of this AGREEMENT have been
satisfied, in addition to any remedies available to FOURNIER for breach,
FOURNIER's obligations as set forth in Section 4.03(C) hereof shall cease.
4.03 Joint Development Strategy and Obligations
(A) RGENE or its sublicensees shall be responsible for, and shall
pay all costs and expenses arising out of and relating to, the preclinical
studies and trials of the LICENSED E1A PRODUCT in the United States. FOURNIER or
its sublicensees shall be responsible for, and shall pay all costs and expenses
arising out of and relating to, the preclinical studies and trials of the
LICENSED E1A PRODUCT in the LICENSED TERRITORY.
(B) The LICENSED E1A PRODUCT shall be manufactured and developed
by RGENE and any sublicensees to the highest ethical and professional standards
and in accordance with Section 5.01 hereof, and coordinated with RGENE's
preclinical and clinical development of the LICENSED E1A PRODUCT in the United
States.
(C) (i) All available information, findings, data, and files
developed or maintained by a PARTY in connection with obtaining and/or
maintaining regulatory approval of the LICENSED E1A PRODUCT shall be promptly
made available, without charge, to the other PARTY upon request, but in no event
later than thirty (30) days after receipt of such request. All such information,
findings, data, and files shall be subject to the confidentiality provisions of
Article 8.0 hereof. Subject to the foregoing sentence, all available information
under the control of a PARTY, whether generated in the United States, the
LICENSED TERRITORY, or any other country outside the LICENSED TERRITORY, shall
be accumulated in a "global file," and such information shall be the basis for
submissions for approval in the United States, the LICENSED TERRITORY, or any
other country outside the LICENSED TERRITORY.
-11-
14
(ii) Each PARTY shall have complete access to the global
file, and shall have the right to refer to and cross-reference the other PARTY's
submissions to GOVERNMENTAL AUTHORITIES, including, without limitation, any IND,
NDA, PLA, and any revision or supplement thereto, consistent with the purpose of
this AGREEMENT and the guidelines set forth in the DEVELOPMENT PLAN. Any data or
information relied on by a PARTY in support of such submissions shall be
appropriately documented and, if not contained in the global file, shall,
subject to Sections 4.01(D) and 4.02(C) hereof, be made available to the other
PARTY. The PARTIES agree to cooperate with all GOVERNMENTAL AUTHORITIES and,
within their respective territories, to comply with all applicable requirements
of such authorities necessary to allow a PARTY to rely on the other PARTY's
data, submissions, or files used in support of a request for approval by such
authorities.
(iii) Each PARTY shall continue to have access to the global
file and, subject to Sections 4.01(D) and 4.02(C) hereof, the other PARTY's
development information after termination of this AGREEMENT, unless such
termination occurs as a result of the failure to meet the obligations set forth
in Section 4.01, 4.02, or 4.03 hereof.
(iv) During the term of this AGREEMENT, each PARTY shall have
a continuing obligation to use due diligence (but in no event later than
seventy-two (72) hours after notification) in reporting to the other PARTY any
adverse reactions associated with the use of the LICENSED E1A PRODUCT in animals
or humans, and shall comply with all applicable requirements in reporting to the
other PARTY and GOVERNMENTAL AUTHORITIES such adverse reaction. Each PARTY shall
immediately transmit to the other PARTY any notice from any GOVERNMENTAL
AUTHORITY that requires such PARTY to perform additional work or provide
additional information regarding the LICENSED E1A PRODUCT or has a material
impact on the marketability of the LICENSED E1A PRODUCT.
(v) The obligation to exchange information, findings, data,
and files developed or maintained by a PARTY in connection with obtaining and/or
maintaining regulatory approval of the LICENSED E1A PRODUCT shall extend to any
AFFILIATE and sublicensee of such PARTY including, without limitation, any
United States and Japanese sublicensees selected by RGENE.
(vi) A PARTY which fails to carry out its obligations as set
forth in Section 4.01 or 4.02 hereof shall be denied access to the other PARTY's
development information as set forth in Section 4.03(C) hereof.
-12-
15
(vii) The sublicensee of a PARTY shall have access to the
information which is or should be contained in the global file to the same
extent as such PARTY.
(D) Each PARTY shall consult with the other PARTY regarding
indications, taking into account feasibility and market data, and shall develop
the LICENSED E1A PRODUCT in conjunction with the other PARTY consistent with the
DEVELOPMENT PLAN. Nothing in this AGREEMENT shall prevent RGENE from utilizing
its sole judgment with respect to the development strategy for the LICENSED E1A
PRODUCT outside the LICENSED TERRITORY. RGENE's activities concerning the
development strategy for the LICENSED E1A PRODUCT in the United States shall be
consistent with RGENE's obligations under Section 4.02 hereof.
(E) Development tasks necessary to obtain regulatory approval in
the LICENSED TERRITORY shall be implemented consistent with the guidelines
established by the DEVELOPMENT COMMITTEE. In case of disagreements, experts,
mutually agreed upon by RGENE and FOURNIER, as well as the respective chief
executive officers of the PARTIES, shall be consulted. In the case of a
deadlock, the PARTIES shall request the opinion of regulatory authorities
including, without limitation, Agence du Medicament and EMEA, or may mutually
agree upon an expert to break such deadlock.
(F) RGENE shall not take or fail to take any action that would
prevent FOURNIER from undertaking any study that a GOVERNMENTAL AUTHORITY in the
LICENSED TERRITORY may require or has approved.
5.0 MANUFACTURING
5.01 (A) Pursuant to the terms of the SUPPLY AGREEMENT to be
negotiated in good faith by the PARTIES based on reasonable terms consistent
with the needs of both PARTIES under this AGREEMENT, and agreed to by the
PARTIES by such time as the final regulatory submissions are filed, RGENE shall:
(i) manufacture, compound, finish, package, and supply the LICENSED E1A PRODUCT,
including, without limitation, Plasmid 1 and Plasmid 2 material, or cause such
product to be manufactured, compounded, finished, packaged, and supplied, in
strict compliance with the regulations, standards, and specifications of all
applicable GOVERNMENTAL AUTHORITIES and regulatory submissions; (ii) not depart
from such regulations, standards, specifications, and regulatory submissions
without the prior written approval of each of such GOVERNMENTAL AUTHORITIES; and
(iii) not sell, distribute, or otherwise release, or cause to be sold,
distributed or otherwise released, to FOURNIER, any AFFILIATE or sublicensee of
FOURNIER, or any other
-13-
16
PERSON such LICENSED E1A PRODUCT that is not in full compliance with such
regulations, standards, specifications, and regulatory submissions, including,
without limitation, the appearance, composition, and quality of such LICENSED
E1A PRODUCT. It is understood and agreed by the PARTIES that RGENE shall supply
Plasmid 1 and Plasmid 2 material to FOURNIER in accordance with this Section
5.01, but in the event that Plasmid 2 material is not suitable for commercial
purposes, then RGENE shall continue to supply Plasmid 1 material to FOURNIER.
(B) RGENE may manufacture the LICENSED E1A PRODUCT itself or have the
LICENSED E1A PRODUCT manufactured under contract by an AFFILIATE, sublicensee,
or subcontractor of RGENE or any other PERSON who agrees to manufacture the
LICENSED E1A PRODUCT. RGENE shall deliver to FOURNIER a true and correct copy of
each agreement for the manufacture of the LICENSED E1A PRODUCT prior to its
execution by RGENE, a copy of the executed agreement, and any modification or
termination thereof, within thirty (30) days after such execution, modification,
or termination. No delegation of its obligations under this Section 5.01 or any
other provision of this AGREEMENT shall serve to relieve RGENE of its
responsibilities hereunder, and, in connection with any such delegation, RGENE
shall be solely responsible for the acts, commitments, and omissions by any of
its AFFILIATES, sublicensees, and subcontractors and any PERSON with whom such
AFFILIATES, sublicensees, and subcontractors contract or otherwise deal. RGENE
shall use its best good-faith efforts that are commercially reasonable to obtain
from any AFFILIATE, sublicensee, subcontractor, and other PERSON to whom RGENE
delegates any obligation under this AGREEMENT a commitment or other agreement
that shall provide for the imposition of penalties and other costs or expenses
against such AFFILIATE, sublicensee, subcontractor, and other PERSON in the
event of the failure by any one or all of them to comply with any provision of
this AGREEMENT, including, without limitation, Sections 5.01 and 5.04 hereof. In
the event that RGENE shall obtain any recovery from such AFFILIATE, sublicensee,
subcontractor, or other PERSON under such commitment or other agreement, RGENE
shall pay to FOURNIER a proportionate share of such recovery in an amount agreed
to in good faith by the PARTIES, which share shall reflect the proportionate
loss suffered by each PARTY.
5.02 (A) Subject to Section 5.01 hereof, the pharmaceutical form of
the LICENSED E1A PRODUCT to be supplied by or on behalf of RGENE to FOURNIER
shall be:
(i) Packaged, ready-to-use vials of lyophilized adequate
cationic lipids; and
-14-
17
(ii) Packaged and vialed, ready-to-use frozen plasmid
material.
(B) FOURNIER shall supply labelling materials for the LICENSED
E1A PRODUCT appropriate for the LICENSED TERRITORY no later than thirty (30)
days prior to (i) the date when such labelling materials are required in
connection with the production of the LICENSED E1A PRODUCT or (ii) the date of
RGENE's confirmation of FOURNIER's purchase order made pursuant to Section 5.04
hereof, whichever is later. Such labelling materials shall include the notation
"Patent Pending" or the number of the appropriate patent or patents, as
prescribed by the applicable GOVERNMENTAL AUTHORITY.
5.03 Transfer Price
(A) TRANSFER PRICE shall mean the unit price agreed to in good
faith by RGENE and FOURNIER to be paid for the LICENSED E1A PRODUCT supplied by
or on behalf of RGENE, whether used for development or commercial purposes,
which price shall be no greater than RGENE's direct cost plus such part of
indirect cost that pertains to quality assurance and control, to be determined
by RGENE in conjunction with FOURNIER, but in no event shall such indirect cost
exceed [*] of RGENE's direct cost. It is understood and agreed by the PARTIES
that, in any FISCAL YEAR of commercial production, the aggregate of (i) the
TRANSFER PRICE (multiplied by the number of units of LICENSED E1A PRODUCT sold
by FOURNIER and its sublicensees) and (ii) the amount of the royalty payment
shall in no instance be greater than the amount of the applicable percentage of
NET SALES as set forth in the schedule under Section 6.04 hereof for said FISCAL
YEAR.
(i) If, at the Phase II consensus conference, the aggregate
of (1) the TRANSFER PRICE (multiplied by the number of units of LICENSED EPA
PRODUCT sold by FOURNIER and its sublicensees) and (2) the amount of the royalty
payment is projected for the first FISCAL YEAR of commercial production to
exceed the amount of the applicable percentage of NET SALES set forth in the
schedule under Section 6.04 hereof for said FISCAL YEAR, then RGENE shall have
no further obligation to manufacture the LICENSED E1A PRODUCT for FOURNIER or
its sublicensees. Additionally, FOURNIER shall, notwithstanding Section 5.07(B)
hereof and in its sole discretion, immediately have the right to manufacture,
have manufactured, develop, have developed, use, produce, and have
- --------
* Confidential Treatment Requested
-15-
18
produced the LICENSED E1A PRODUCT, and RGENE shall immediately furnish to
FOURNIER all manufacturing information, technology, and other know-how for the
LICENSED E1A PRODUCT.
(ii) If in the first FISCAL YEAR of commercial production
under this AGREEMENT, the aggregate of (1) the TRANSFER PRICE (multiplied by the
number of units of LICENSED E1A PRODUCT sold by FOURNIER and its sublicensees)
and (2) the amount of the royalty payment exceeds the amount of the applicable
percentage of NET SALES set forth in the schedule under Section 6.04 hereof for
said FISCAL YEAR, then, notwithstanding the foregoing, FOURNIER shall pay to
RGENE, for said FISCAL YEAR only, for LICENSED E1A PRODUCT sold by FOURNIER and
its sublicensees during said FISCAL YEAR an amount equal to the TRANSFER PRICE
(multiplied by the number of units of LICENSED E1A PRODUCT sold by FOURNIER and
its sublicensees), which amount shall not exceed [*] of NET SALES for said
FISCAL YEAR. Any credit due to FOURNIER shall be taken in the subsequent FISCAL
YEAR. There shall be no royalty payment owed by FOURNIER for said FISCAL YEAR
under Section 6.04 hereof, and RGENE shall have no further obligation to
manufacture the LICENSED E1A PRODUCT for FOURNIER or its sublicensees.
Additionally, FOURNIER shall, notwithstanding Section 5.07(B) hereof and in its
sole discretion, immediately have the right to manufacture, have manufactured,
develop, have developed, use, produce, and have produced the LICENSED E1A
PRODUCT, and RGENE shall immediately furnish to FOURNIER all manufacturing
information, technology, and other know-how for the LICENSED E1A PRODUCT.
(iii) In the event FOURNIER exercises its right under
Section 5.03(A)(i) or (ii) hereof, RGENE shall have the opportunity to review
FOURNIER's calculations of its cost to manufacture the LICENSED E1A PRODUCT, and
any underlying financial documentation pertaining thereto, to validate said
calculations.
(B) On the date of the shipment of any LICENSED E1A PRODUCT to
FOURNIER, RGENE shall forward to FOURNIER an invoice for the quantity of such
LICENSED E1A PRODUCT in such shipment. Within thirty (30) days after its receipt
of such invoice, FOURNIER shall pay to RGENE fifty percent (50%) of the amount
of such invoice. FOURNIER shall, subject to Sections 5.03(C) and 5.05 hereof,
pay the unpaid balance of such invoice after FOURNIER confirms delivery of such
shipment by visual inspection, but in no event later than thirty (30)
- --------
* Confidential Treatment Requested
-16-
19
days after delivery to the customs department in France or the applicable
LICENSED TERRITORY.
(C) If FOURNIER determines in good faith that any LICENSED E1A
PRODUCT does not conform to the requirements of Section 5.01 hereof, then
FOURNIER, in addition to any other remedies it may have under this AGREEMENT,
shall have the right to return such LICENSED E1A PRODUCT and deduct from the
invoice or any future invoice the AGGREGATE TRANSFER PRICE and all costs and
expenses relating to such return.
5.04 Purchase Orders
(A) Purchase orders for LICENSED E1A PRODUCT, whether for
development or commercial purposes, shall be governed by this Section 5.04,
unless otherwise modified by the SUPPLY AGREEMENT negotiated by the PARTIES
pursuant to Section 5.01 hereof, which agreement shall comply with the terms of
this Article 5.0.
(B) FOURNIER shall provide RGENE with a purchase order for its
required clinical materials in 1996 and 1997 no later than sixty (60) days after
the effective date of this AGREEMENT, and RGENE shall supply to FOURNIER such
materials in the quantity and by the date specified in such purchase order.
There shall be no penalty on the part of RGENE for its failure to provide such
clinical materials, except in the case of gross negligence.
(C) On or before November 30, 1996, or such later date to be
ascertained upon obtaining additional technical information concerning the
stability of the LICENSED E1A PRODUCT and manufacturing capacity, FOURNIER shall
provide RGENE with a purchase order for clinical materials that FOURNIER
reasonably estimates it will require in 1998. If RGENE fails to supply the
clinical materials as specified in such purchase order, then RGENE shall pay to
FOURNIER a penalty of [*] for late delivery, commencing thirty (30) days after
the delivery date specified in such purchase order. RGENE shall have fulfilled
its obligation to deliver the LICENSED E1A PRODUCT by the date specified in such
purchase order by delivering such product by such date to customs in the
applicable LICENSED TERRITORY and shall not be assessed any penalty under this
Section 5.04(C) or Section 5.04(D) hereof for a late shipment resulting from any
delay in processing the
- --------
* Confidential Treatment Requested
-17-
20
LICENSED E1A PRODUCT through customs in the applicable LICENSED TERRITORY,
except where such delay is caused by RGENE or is within its control.
(D) On or before November 30, 1997 and on or before November 30
of each subsequent FISCAL YEAR, or such later date to be ascertained upon
obtaining additional technical information concerning the stability of the
LICENSED E1A PRODUCT and manufacturing capacity, FOURNIER shall provide RGENE
with a purchase order for clinical materials that FOURNIER reasonably estimates
it will require in 1999 and each subsequent FISCAL YEAR commencing thirteen (13)
months after such November 30, respectively. If RGENE fails to supply the
clinical materials as specified in any purchase order, then RGENE shall pay to
FOURNIER the penalty specified in Section 5.04(C) hereof, with the exception
described in said section.
(E) Purchase Order Changes
(i) RGENE agrees to use its best good-faith efforts to
accommodate any changes in FOURNIER's purchase orders related to the quantity of
LICENSED E1A PRODUCT and the date of delivery.
(ii) Subject to Sections 5.03(C), 5.04(D), 5.04(E)(i), and
5.04(E)(iv) hereof, FOURNIER shall remain liable for any payments due for a
quantity of LICENSED E1A PRODUCT requested in an original purchase order, unless
FOURNIER notifies RGENE in writing of a revision to such purchase order before
the last date by which the manufacturer of such LICENSED E1A PRODUCT has
specified in writing to FOURNIER that it can accept a change in the quantity of
LICENSED E1A PRODUCT in such purchase order and thereby reduce FOURNIER's
liability.
(iii) RGENE shall not be liable, and shall not be required to
pay any penalty, for failing to deliver to FOURNIER quantities of LICENSED E1A
PRODUCT which are sought by FOURNIER in excess of the amount requested in an
original purchase order.
(iv) Notwithstanding any other provision of this AGREEMENT,
RGENE and FOURNIER may mutually agree to a revised purchase order which shall
supersede the original purchase order to which it relates.
5.05 Title to and risk of loss for any shipment of LICENSED E1A
PRODUCT, or components thereof, by RGENE or any of its AFFILIATES, sublicensees
or subcontractors to FOURNIER or its sublicensees shall pass to FOURNIER upon
receipt by FOURNIER or its sublicenses of such shipment after its
-18-
21
passage through customs. FOURNIER shall use its best good-faith efforts to
obtain clearance of any such shipment through customs.
5.06 All LICENSED E1A PRODUCT shipped by or on behalf of RGENE or any
of its AFFILIATES, sublicensees, or subcontractors pursuant to this AGREEMENT
shall be in accordance with the provisions of Section 5.01 hereof. RGENE shall
use its best good-faith efforts that are commercially reasonable and permitted
by law or government regulations to afford FOURNIER a priority in replacement of
any LICENSED E1A PRODUCT returned to RGENE pursuant to Section 5.03(C) hereof.
5.07 Secondary Supplier of LICENSED E1A PRODUCT
(A) The PARTIES recognize that it is in their mutual best
interest to provide for a back-up supplier of the LICENSED E1A PRODUCT for both
the LICENSED TERRITORY and the United States to the extent feasible under then
existing regulations in the LICENSED TERRITORY and the United States. The
PARTIES shall consult in good faith regarding the best means of accomplishing
this important objective, within the scope of RGENE's underlying licenses with
the LICENSORS.
(B) RGENE shall grant to FOURNIER the right to manufacture, have
manufactured, develop, have developed, use, produce, and have produced, the
LICENSED E1A PRODUCT for sale by FOURNIER and/or RGENE, provided that: (i) the
LICENSED E1A PRODUCT shall have been marketed and sold in the LICENSED
TERRITORY; (ii) FOURNIER shall have provided RGENE with its good-faith
reasonable projection that FOURNIER's cost to produce the LICENSED E1A PRODUCT
will be no greater that RGENE's total cost to produce the LICENSED E1A PRODUCT,
including applicable subcontractor costs but excluding transportation and
shipping costs (RGENE shall provide to FOURNIER sufficient information for such
projection to be made); and (iii) the consent of the LICENSORS has been
obtained. In the event that RGENE grants to FOURNIER such right, RGENE shall
transfer all manufacturing information, technology, and other know-how to
FOURNIER on the same terms and conditions it would to any other potential
secondary supplier. In the event that FOURNIER becomes a manufacturer of
LICENSED E1A PRODUCT, RGENE shall not be obligated to purchase LICENSED E1A
PRODUCT from FOURNIER. It is understood and agreed by the PARTIES that with
respect to LICENSED E1A PRODUCT comprising LICENSED CATIONIC LIPID SUBJECT
MATTER under the terms of RGENE's license from UTRC, such products sold in the
United States are required to be manufactured substantially in the United
States.
-19-
22
6.0 PAYMENTS AND ROYALTIES
6.01 In consideration of the license granted by RGENE to the LICENSED
E1A PRODUCT, FOURNIER agrees to pay, and RGENE agrees to accept, the payments
and royalties set forth in this Article 6.0.
6.02 Upfront Payments
(A) FOURNIER shall pay to RGENE an upfront payment in the amount
of Five Million Dollars ($5,000,000 U.S.) on or before June 5, 1996, less the
following payments which RGENE acknowledges and agrees have been heretofore paid
and received by RGENE and are being credited against the amount of the upfront
payments:
(i) Two Million Dollars ($2,000,000 U.S.) paid on or about
December 28, 1995 for FOURNIER's option to become an exclusive licensee; and
(ii) Five Hundred Thousand Dollars ($500,000 U.S.) paid on or
about February 28, 1996 for the extension of such option.
(B) It is understood and agreed by the PARTIES that the sum of
Two Hundred Fifty Thousand Dollars ($250,000) of the total amount paid pursuant
to Section 6.02(A) hereof represents the upfront license fee for the LICENSED
PATENT RIGHTS covering the LICENSED CATIONIC LIPID SUBJECT MATTER.
6.03 Milestone Payments
It is further understood and agreed by the PARTIES that, within thirty (30)
days after receipt by FOURNIER of notice and confirmation of achievement of each
of the milestones set forth in subsections (A), (B), (C), and (D) of this
Section 6.03, and within sixty (60) days after receipt by FOURNIER of notice and
confirmation of achievement of the milestones set forth in subsections (E) and
(F) of this Section 6.03, FOURNIER shall pay to RGENE the sum specified for each
such milestone as FOURNIER's contribution toward the research previously
conducted by RGENE in connection with the LICENSED E1A PRODUCT:
(A) [*]: Enrollment of the first patient in a clinical trial in
the United States for any LICENSED E1A PRODUCT;
- --------
* Confidential Treatment Requested
-20-
23
(B) [*]: Approval by a GOVERNMENTAL AUTHORITY for European
clinical trials for any LICENSED E1A PRODUCT;
(C) [*]: Approval for any LICENSED E1A PRODUCT, which includes a
second plasmid, to enter clinical trials in the United States;
(D) [*]: Enrollment of more than fifty (50) patients in the
United States in a clinical trial of any LICENSED E1A PRODUCT;
(E) [*]: RGENE or any AFFILIATE or sublicensee of RGENE obtaining
approval of a PLA for any LICENSED E1A PRODUCT; and
(F) [*]: FOURNIER or any AFFILIATE or sublicensee of FOURNIER
obtaining approval by the EMEA for any LICENSED E1A PRODUCT.
6.04 Royalties
(A) Subject to Sections 5.03(A), 6.04(C), 6.04(D), and 6.05
hereof, FOURNIER shall pay royalties to RGENE for any FISCAL YEAR during the
term of this AGREEMENT according to the following schedule:
NET SALES IN A FISCAL YEAR PRICE (ROYALTIES
(U.S. DOLLARS) + COST OF GOODS)
- --------------------------------------------------------------------------------
[*]
- --------------------------------------------------------------------------------
(B) Subject to Section 6.05 hereof, royalties shall be paid at
the end of the first FISCAL YEAR of sales, and thereafter quarterly in
accordance with Section 6.07 hereof.
(C) Subject to Section 5.03 hereof, FOURNIER shall be permitted
to deduct from the total amount of royalty payment due in each period the actual
amount of the AGGREGATE TRANSFER PRICE paid by FOURNIER to RGENE for the
LICENSED E1A PRODUCT bought by FOURNIER which resulted in the NET SALES for
which a royalty is due to RGENE. The amount of the royalty payment due shall be
calculated according to the following formula:
- --------
* Confidential Treatment Requested
-21-
24
Royalty payment = (Royalty Rate X NET SALES) - AGGREGATE TRANSFER
------------ PRICE.
100
(D) In the event that FOURNIER shall manufacture all or a portion
of the products that are the subject of this AGREEMENT, the PARTIES shall
determine jointly the appropriate TRANSFER PRICE to be deducted for the purpose
of calculating royalty payments, but in no event shall such TRANSFER PRICE be
greater than the TRANSFER PRICE that would have been deducted had RGENE supplied
the LICENSED E1A PRODUCT.
6.05 For purposes of determining when royalties are earned, LICENSED
E1A PRODUCT shall be deemed to have been sold when billed by FOURNIER to a
customer or, if not billed, when delivered or shipped by FOURNIER to a customer.
The failure of any customer to pay an invoice submitted by FOURNIER for such
LICENSED E1A PRODUCT shall not affect the obligation of FOURNIER to pay the
current royalty amount due to RGENE; provided, however, that any royalties paid
on (A) LICENSED E1A PRODUCTS that are returned or not accepted by customers and
(B) billings or shipments for which FOURNIER does not receive payment shall be
credited against subsequent royalty payments due RGENE under this AGREEMENT. In
the case of a sale of a LICENSED E1A PRODUCT for consideration other than money,
such sale shall be considered to have been made on the date of delivery or
shipment.
6.06 FOURNIER shall keep accurate records showing the number of sales,
NET SALES prices, and date of sale of all LICENSED E1A PRODUCTS sold by FOURNIER
and its sublicensees. FOURNIER shall, within seventy-five (75) days after the
end of each calendar quarter, furnish to RGENE a statement showing the number of
sales and NET SALES prices of all LICENSED E1A PRODUCTS sold by FOURNIER and its
sublicensees during such calendar quarter. FOURNIER shall, upon written request
by RGENE, make the records available for inspection by an independent certified
public accountant appointed by RGENE once each FISCAL YEAR at FOURNIER's place
of business during normal business hours and on a confidential basis. In the
event that the amounts due to RGENE are determined, by such accountant, to have
been underpaid by ten percent (10%) or more, FOURNIER shall pay the cost of such
examination and accrued interest on the amount of such underpayment at a rate of
twelve percent (12%) per annum or at the highest rate allowed by law, if lower.
6.07 Within seventy-five (75) days after the end of the first FISCAL
YEAR of sales under this Agreement, FOURNIER shall pay to RGENE the royalty
amount due for such FISCAL YEAR, as calculated in accordance with Sections 5.03,
6.04 and 6.05 hereof. For each calendar quarter of a FISCAL YEAR thereafter,
-22-
25
FOURNIER shall submit to RGENE, along with the statement prepared pursuant to
Section 6.06 hereof, the total amount of royalties shown thereby to be due, as
calculated pursuant to Sections 5.03, 6.04 and 6.05 hereof. Each payment made to
RGENE pursuant to this AGREEMENT shall be made in lawful funds of the United
States of America. Any conversion of currency into United States dollars for the
purpose of making a payment to RGENE for royalties shall be at the prevailing
rate of exchange of the currency of the country in which the sale of the
LICENSED E1A PRODUCT was made as quoted by CITIBANK, N.A. of New York for the
last business day of the calendar quarter for which the royalties are payable.
6.08 Any royalty payment which is overdue shall be subject to a late
payment charge which shall be equal to the prime rate quoted in The Wall Street
Journal for a major New York bank on the date due (or if not quoted on that
date, the next date on which the prime rate is quoted) during the entire period
of delinquency. The maximum amount of the late charge shall not exceed that
permitted by law for such a charge.
7.0 IMPROVEMENTS
7.01 Any IMPROVEMENT made or otherwise developed by only one PARTY
shall be solely owned by such PARTY. Any IMPROVEMENT made or otherwise developed
jointly by the PARTIES shall be owned by RGENE and FOURNIER in common. If
patentable, all IMPROVEMENTS, whether made by a PARTY or both PARTIES, shall be
protected by filing patent applications, prepared by the PARTY or PARTIES in its
or their own name, as the case may be, who made or developed such IMPROVEMENT.
7.02 Each PARTY shall promptly disclose to the other PARTY all
IMPROVEMENTS made by such PARTY or its AFFILIATES or sublicensees. Any
IMPROVEMENT shall become part of the LICENSED TECHNOLOGY or LICENSED PATENT
RIGHTS and, subject to Section 7.04 hereof, made available to the other PARTY
under a royalty-free license for using or selling such IMPROVEMENT. A royalty
for the use of an IMPROVEMENT in which the LICENSORS have rights, shall be paid
by FOURNIER on terms to be negotiated in good faith among RGENE, FOURNIER and
the LICENSORS having rights in the IMPROVEMENT.
7.03 Either PARTY may generate IMPROVEMENTS without approval from or
prior notice to the DEVELOPMENT COMMITTEE or the other PARTY, but shall promptly
thereafter notify the DEVELOPMENT COMMITTEE and the other PARTY of its actions
in accordance with Section 7.02 hereof.
-23-
26
7.04 If, no later than sixty (60) days after the disclosure of an
IMPROVEMENT by a PARTY ("PROPOSING PARTY") pursuant to Section 7.02 hereof, the
other PARTY (the "NON-PROPOSING PARTY") agrees to continue the joint development
of such IMPROVEMENT, then the NON-PROPOSING PARTY shall immediately pay to the
PROPOSING PARTY an amount equal to fifty percent (50%) of the costs incurred by
the PROPOSING PARTY in generating, conceiving, and developing such IMPROVEMENT
up to the date of such payment by the NON-PROPOSING PARTY, and thereafter the
PROPOSING PARTY and the NON-PROPOSING PARTY shall each pay fifty percent (50%)
of the costs associated with the development of such IMPROVEMENT; provided,
however, that an agreement by the NON-PROPOSING PARTY to continue the job
development of an IMPROVEMENT shall not change the ownership of such IMPROVEMENT
as provided in Section 7.01 hereof. If no decision has been made by the NON-
PROPOSING PARTY with respect to such IMPROVEMENT by the expiration of such sixty
(60)-day period, then the PROPOSING PARTY shall be free to continue development
of such IMPROVEMENT by itself.
7.05 If a NON-PROPOSING PARTY, which had previously not agreed to
continue the joint development of an IMPROVEMENT or contributed to the cost of
development of such IMPROVEMENT in accordance with Section 7.04 hereof, later
desires access to such IMPROVEMENT, then the NON-PROPOSING PARTY shall pay to
the PROPOSING PARTY an amount equal to fifty percent (50%) of the costs incurred
by the PROPOSING PARTY in generating, conceiving, and developing such
IMPROVEMENT up to the date of such payment by the NON-PROPOSING PARTY, shall
continue to pay fifty percent (50%) of the costs associated with the development
of such IMPROVEMENT, and shall be entitled to a license after good-faith
discussions by the PARTIES, which license shall not necessarily be royalty-free,
in the sole discretion of the PROPOSING PARTY.
7.06 If a PARTY manufactures a product developed as an IMPROVEMENT
under either Section 7.04 or 7.05 hereof, then such product shall be made
available to the other PARTY for a price to be negotiated by the PARTIES that
reasonably reflects the cost of manufacture of such product.
8.0 CONFIDENTIALITY
8.01 Each of the PARTIES agrees that it shall use diligent,
reasonable, and prudent efforts to maintain the confidential nature of all
confidential information, including, without limitation, all information
relating to or developed or exchanged pursuant to this AGREEMENT, the LICENSED
E1A SUBJECT MATTER, LICENSED CATIONIC LIPID SUBJECT MATTER, LICENSED TECHNOLOGY,
IMPROVEMENTS, and the information, findings, data, and files pursuant to
-24-
27
Section 4.03(C) hereof, original documents, patent applications, data analysis,
drawings, models, samples, any organism, cultures, compounds and devices,
mammographs, specifications, flow sheets, descriptions, submissions to
regulatory authorities, and other tangible material and copies thereof
(collectively, the "CONFIDENTIAL INFORMATION") that is not public knowledge.
Each of the PARTIES agrees that all CONFIDENTIAL INFORMATION transferred by one
PARTY to the other PARTY, orally or in writing, shall: (A) be held in strict
confidence, (B) be used only for the purposes contemplated by this AGREEMENT,
and (C) not be disclosed by the receiving PARTY (except as required by law) or
by its officers, directors, employees, or agents without the prior written
consent of the forwarding PARTY, unless such information (i) was in the public
domain at the time of disclosure, (ii) later became part of the public domain
through no act or omission of the receiving PARTY or its officers, directors,
employees, agents, successors or assigns, (iii) was lawfully disclosed to the
receiving PARTY by a PERSON having the right to disclose it, (iv) was already
known to the receiving PARTY, at the time of disclosure as demonstrated by
written documents existing at the time of the initial disclosure, (v) was
independently conceived, discovered, or reduced to practice as demonstrated by
written documents existing at the time of the initial disclosure, (vi) is
required to be submitted to a GOVERNMENTAL AUTHORITY pursuant to any obligation
imposed or right granted hereunder, or (vii) is required by law or court order
to be disclosed. The foregoing obligation of confidentiality shall survive any
termination of this AGREEMENT for a period of ten (10) years.
8.02 It is understood and agreed by the PARTIES that RGENE has an
obligation to fully disclose to UTRC all improvements (as that term is used in
the agreement between RGENE and UTRC dated October 12, 1995) and modifications
of the LICENSED E1A PRODUCTS using the LICENSED CATIONIC LIPID SUBJECT MATTER.
The University of Tennessee, McMaster, and UTRC shall have, during the term of
this AGREEMENT, a non-exclusive, non-transferable royalty-free license to
utilize said improvements and modifications for research and academic purposes
only. In the event that RGENE's rights from UTRC are terminated by UTRC due to a
default by RGENE, UTRC and McMaster shall have the right to obtain from RGENE a
royalty-free license (with the right to sublicense) to manufacture, use and sell
only such IMPROVEMENTS and modifications for any commercial or non-commercial
purpose that are owned solely by RGENE in accordance with Section 7.01 hereof.
The University of Tennessee, UTRC, and McMaster shall have the right to any
IMPROVEMENT or modification that is owned solely by FOURNIER or jointly by
FOURNIER and RGENE for research and academic purposes only.
-25-
28
8.03 Publications
(A) Neither PARTY shall cause any publication or communication to
the media or the general public of CONFIDENTIAL INFORMATION or information
concerning the LICENSED E1A Product or related clinical data, without the prior
written authorization from the other PARTY. Such authorization shall not be
unreasonably withheld and shall be granted in a timely manner.
(B) Each PARTY shall use its best good-faith efforts that are
commercially reasonable to require any PERSON associated with any clinical trial
to agree to maintain the confidentiality of all CONFIDENTIAL INFORMATION under
terms not materially different from Section 8.01 hereof.
(C) RGENE shall use its best good-faith efforts that are
commercially reasonable to include the confidentiality provisions set forth in
Section 8.01 hereof, or provisions which are not materially different from the
provisions set forth in such section, in its agreements with any of its
AFFILIATES, sublicensees, or subcontractors concerning rights of the LICENSED
E1A PRODUCT outside the LICENSED TERRITORY. RGENE shall notify FOURNIER in
writing prior to authorizing the release of CONFIDENTIAL INFORMATION by any of
its AFFILIATES, sublicensees, or subcontractors.
9.0 ENFORCEMENT
9.01 If either PARTY has knowledge or believes in good faith that any
of the CONFIDENTIAL INFORMATION has been improperly disclosed or otherwise
released or that any of the LICENSED PATENT RIGHTS have been infringed by any
PERSON, then such PARTY shall immediately notify, but in no event later than
five (5) days after its receipt of such knowledge or belief, the other PARTY in
writing, which notice shall set forth the acts and other information relating to
such disclosure, release, or infringement in reasonable detail.
9.02 RGENE and the LICENSORS shall have the responsibility for
enforcing the LICENSED PATENT RIGHTS in the United States and the LICENSED
TERRITORY.
9.03 (A) RGENE and the LICENSORS shall have up to ninety (90) days
following knowledge within which to elect to prosecute or otherwise enforce the
LICENSED PATENT RIGHTS in the LICENSED E1A SUBJECT MATTER in the LICENSED
TERRITORY or to maintain any patent applications or patents that may be included
within such LICENSED PATENT RIGHTS; provided,
-26-
29
however, that such election shall not be made later than thirty (30) days prior
to any applicable statutory bar or response date. If neither RGENE nor the
LICENSORS elect to prosecute or otherwise enforce such LICENSED PATENT RIGHTS or
to maintain such patent applications or patents, then RGENE shall immediately
notify FOURNIER in writing of such election, and FOURNIER, at its own expense,
shall be entitled to conduct or commence any action, claim, or proceeding to
maintain or prevent disclosure or infringement of such LICENSED PATENT RIGHTS.
RGENE shall be entitled to participate in any monetary recovery obtained by
FOURNIER as a result of such action, claim, or proceeding if and only to the
extent that RGENE has shared equally in or reimbursed fifty percent (50%) of
FOURNIER's costs and expenses incurred in connection with such action, claim, or
proceeding from the inception of same. Subject to Section 9.05 hereof, FOURNIER
shall remain responsible for any royalty payments as may be required under
Section 6.04 hereof. If RGENE or the LICENSORS fail to prosecute or otherwise
enforce the LICENSED PATENT RIGHTS in the LICENSED E1A SUBJECT MATTER in the
United States and such failure adversely affects the supply of the LICENSED E1A
PRODUCT or the financial feasibility of or the ability to sell such product,
FOURNIER shall, notwithstanding Section 5.07(B) hereof, immediately have the
right to manufacture, have manufactured, develop, have developed, use, produce,
and have produced the LICENSED E1A PRODUCT, and RGENE shall immediately furnish
to FOURNIER all manufacturing information, technology, and other know-how for
the LICENSED E1A PRODUCT.
(B) RGENE and the LICENSORS shall have up to ninety (90) days
following knowledge within which to elect to prosecute or otherwise enforce the
LICENSED PATENT RIGHTS in the LICENSED CATIONIC LIPID SUBJECT MATTER in the
LICENSED TERRITORY or to maintain any patent applications or patents that may be
included within such LICENSED PATENT RIGHTS; provided however, that such
election shall not be made later than thirty (30) days prior to any applicable
statutory bar or response date. If (i) RGENE has been given the right by the
LICENSORS to enforce the LICENSED PATENT RIGHTS in the LICENSED CATIONIC LIPID
SUBJECT MATTER; (ii) RGENE elects not to prosecute or otherwise enforce such
LICENSED PATENT RIGHTS; and (iii) the LICENSORS consent to having FOURNIER
prosecute or otherwise enforce such LICENSED PATENT RIGHTS, then RGENE shall
immediately notify FOURNIER in writing of such election, and FOURNIER, at its
own expense, shall be entitled to conduct or commence any action, claim, or
proceeding to maintain or prevent disclosure or infringement of such LICENSED
PATENT RIGHTS. Should FOURNIER conduct or commence any such action, claim, or
proceeding and obtain any recovery of damages, such recovery by FOURNIER shall,
in the first instance, be applied to reimburse FOURNIER for all of its costs and
expenses, including, without
-27-
30
limitation, attorneys' fees and expenses incurred in connection with such
action, claim, or proceeding, and the balance of any such recovery, if any,
shall be divided equally between FOURNIER and UTRC if RGENE elected not to
participate in such action, claim, or proceeding. RGENE shall be entitled to
receive a portion of such balance of any recovery obtained by FOURNIER as a
result of such action, claim, or proceeding if and only to the extent that RGENE
has shared equally in or reimbursed fifty percent (50%) of FOURNIER's costs and
expenses incurred in connection with such action, claim, or proceeding from the
inception of same. Subject to Section 9.05 hereof, FOURNIER shall remain
responsible for any royalty payments as may be required under Section 6.04
hereof. If RGENE or the LICENSORS fail to prosecute or otherwise enforce the
LICENSED PATENT RIGHTS in the LICENSED CATIONIC LIPID SUBJECT MATTER in the
United States and such failure adversely affects the supply of the LICENSED E1A
PRODUCT or the financial feasibility of or the ability to sell such product,
FOURNIER shall, notwithstanding Section 5.07(B) hereof, immediately have the
right to manufacture, have manufactured, develop, have developed, use, produce,
and have produced the LICENSED E1A PRODUCT, and RGENE shall immediately furnish
to FOURNIER all manufacturing information, technology, and other know-how for
the LICENSED E1A PRODUCT.
9.04 In any action, claim, or proceeding that a PARTY may institute to
prosecute or otherwise enforce the LICENSED PATENT RIGHTS or to maintain the
patent applications that may be included within such LICENSED PATENT RIGHTS, the
other PARTY shall, at the request and expense of the PARTY initiating such
action, claim, or proceeding, (A) cooperate in all respects with such PARTY, (B)
to the extent practicable, have its officers, directors, employees, and agents
testify when requested, and (C) make available all relevant records, papers,
information, samples, specimens, correspondence, documents, patents, patent
applications, and other information relating to the LICENSED PATENT RIGHTS.
9.05 Notwithstanding any of the foregoing, it is understood and agreed
that the PARTIES shall meet promptly and negotiate in good faith whether or not
a reduction in the royalty payments under Section 6.04 hereof or any other
changes to this AGREEMENT are appropriate in the event that there is a
significant change in the market or the economic position of the LICENSED E1A
PRODUCT. The factors to be considered shall include, but are not limited to, (A)
whether RGENE or the LICENSORS are unable to uphold the validity of any granted
patent within the LICENSED PATENT RIGHTS against any alleged infringer, (B) a
determination by a court of last resort from which no appeal may be taken that
any patents in a country within the LICENSED TERRITORY covering the LICENSED E1A
PRODUCT are invalid, and which results in the loss of exclusivity regarding such
products, (C) the
-28-
31
value of know-how supplied by RGENE, (D) any exclusivity provided
by regulations or statutes of any GOVERNMENTAL AUTHORITIES beyond or in addition
to that provided by patents, (E) any exclusivity provided by patents in
jurisdictions in which the LICENSED E1A PRODUCT is manufactured, (F) marketing
in the LICENSED TERRITORY by any PERSON of a product that infringes any claim of
the LICENSED PATENT RIGHTS, (G) an adverse impact on the supply of the LICENSED
E1A PRODUCT or the financial feasibility of or the ability to sell such product,
and (H) whether the validity or viability of the LICENSED PATENT RIGHTS in the
LICENSED TERRITORY is adversely affected.
9.06 Infringement of a PERSON's Intellectual Property Rights
(A) RGENE makes no warranties that practicing the LICENSED E1A
SUBJECT MATTER will not infringe any PERSON's intellectual property rights. In
the event of such infringement, FOURNIER shall cooperate with RGENE and/or the
LICENSORS to negotiate and settle with any such PERSON concerning infringement
of such PERSON's intellectual property rights and otherwise resolve any such
infringement and secure RGENE's and FOURNIER's continued rights to such PERSON's
intellectual property rights.
(B) RGENE shall have up to ninety (90) days following knowledge
within which to elect to contest or otherwise defend any suit or claim brought
by any PERSON within or outside the LICENSED TERRITORY that alleges infringement
of such PERSON's intellectual property rights by the manufacture of the LICENSED
E1A PRODUCT by RGENE or which may jeopardize the supply of the LICENSED E1A
PRODUCT to FOURNIER or the ability of FOURNIER to sell such LICENSED E1A PRODUCT
in the LICENSED TERRITORY; provided, however, that such election shall not be
made later than thirty (30) days prior to any applicable statutory bar or
response date. If RGENE elects not to contest or otherwise defend any such suit
or claim or is unable or unwilling to obtain a license from such PERSON, then
RGENE shall immediately notify FOURNIER in writing, and FOURNIER shall have the
right, at FOURNIER's cost and expense, to contest or otherwise defend any such
suit or claim brought by any such PERSON within or outside the LICENSED
TERRITORY. Prior to settling or otherwise compromising any such suit or claim,
FOURNIER shall consult with RGENE, and shall not settle or otherwise compromise
any such suit or claim without RGENE's prior consent, which consent shall not be
unreasonably withheld or delayed. Any cost or expense incurred or settlement or
judgment paid by FOURNIER under this Section 9.06 shall be deducted by FOURNIER
from any payment that is due pursuant to Article 6.0 hereof; provided, however,
that the amount of any such deduction in any FISCAL YEAR shall not be greater
than fifty percent (50%) of the payment otherwise due pursuant to
-29-
32
Article 6.0 hereof. Any balance remaining after application of the fifty percent
(50%) limitation on the deduction shall be carried forward to subsequent FISCAL
YEARS, subject again to the same fifty percent (50%) limitation.
9.07 By the time the LICENSED E1A PRODUCT enters commercial
production, each PARTY shall: (A) have obtained and thereafter carry such
liability insurance as would reasonably be expected of a company based upon and
appropriate for the nature and risk associated with the development,
manufacture, distribution, and sale of a comparable gene therapy product, in an
amount agreed to by the PARTIES on a claims made basis, (B) at all times during
the term of this AGREEMENT when such PARTY or its AFFILIATE, sublicensee, or
subcontractor is engaged in the manufacture of the LICENSED E1A PRODUCT, list
the other PARTY as an additional named insured on the policy of such liability
insurance, and (C) provide written evidence of such insurance to the other PARTY
upon request.
10.0 PATENTS AND INVENTIONS
RGENE shall, at its sole cost and expense, have the responsibility for
searching, filing, prosecuting and maintaining patent applications and patents
relating to the LICENSED PATENT RIGHTS in the LICENSED TERRITORY.
11.0 TERM
11.01 This Agreement shall terminate upon the later of:
(A) The expiration date of the last to expire patent issued
pursuant to the LICENSED PATENT RIGHTS (including any supplemental protection
certificate); provided, however, that if any patent within the LICENSED PATENT
RIGHTS is declared invalid by a court of competent jurisdiction from which no
further appeal may or has been taken, then such patent shall be considered to
have expired; or
(B) Ten (10) years from the date of the first sale of the
LICENSED E1A PRODUCT in the LICENSED TERRITORY.
11.02 (A) A PARTY may terminate this AGREEMENT for breach by the other
PARTY of any material obligation under this AGREEMENT, if such breach is not
remedied within sixty (60) days after receipt of notice in writing of such
breach given by such PARTY, unless (i) such breach was outside the control of
the other PARTY, and (ii) the other PARTY provides, within sixty (60) days after
receipt of notice of such breach, written evidence of its commercially
reasonable, good-faith
-30-
33
efforts to cure such breach, in which case there shall be no termination of this
AGREEMENT.
(B) A PARTY shall have the right to cure any breach or default of
the other PARTY with respect to any obligation the defaulting PARTY may have to
any PERSON without waiver of any rights the non-defaulting PARTY may have
against the defaulting PARTY and the right of the non-defaulting PARTY to seek
reasonable compensation from the defaulting PARTY to cover the cost associated
with curing such breach or default.
11.03 RGENE may terminate this AGREEMENT for the failure by FOURNIER
to make any payment as required pursuant to Sections 6.03 and 6.04 hereof thirty
(30) days after receipt by FOURNIER of notice of such failure, which notice
shall be sent by RGENE to FOURNIER in accordance with Section 14.02 hereof.
11.04 This AGREEMENT may be terminated due to unsatisfactory results
as determined by mutual consent of the PARTIES at a Phase II consensus
conference to be held by the PARTIES on or about the second anniversary of this
AGREEMENT.
11.05 This AGREEMENT shall automatically terminate, in its entirety,
if FOURNIER shall become bankrupt or insolvent or the business of FOURNIER shall
be placed in the hands of a receiver. In the event that either PARTY enters into
a bankruptcy, insolvency, or receivership, the other PARTY shall have a right of
first refusal to all rights transferred to such PARTY under this AGREEMENT.
11.06 Upon any termination of this AGREEMENT for any reason, nothing
herein shall be construed to release either PARTY from any obligation that has
matured or otherwise become due prior to the effective date of such termination.
FOURNIER may, after the effective date of such termination, sell to customers or
return to RGENE all LICENSED E1A PRODUCT in FOURNIER's possession on such
effective date. In the event that FOURNIER elects to sell such LICENSED E1A
PRODUCT, then FOURNIER shall be obligated to pay royalties in accordance with
Section 6.04 hereof.
11.07 Upon and effective as of the date of termination of this
AGREEMENT by RGENE pursuant to Section 11.02, 11.03 or 11.05 hereof:
(A) All licenses to IMPROVEMENTS granted by FOURNIER to RGENE
under Sections 7.05 and 7.06 hereof shall continue in full force and effect; and
-31-
34
(B) FOURNIER shall, on terms to be negotiated in good faith by
the PARTIES, grant to RGENE a royalty-free license with the right to sublicense
with respect to any IMPROVEMENTS made solely by FOURNIER in the LICENSED E1A
SUBJECT MATTER, which IMPROVEMENT has not yet been licensed to RGENE, provided
(i) FOURNIER had provided notice of such IMPROVEMENT to the DEVELOPMENT
COMMITTEE or RGENE; and (ii) RGENE had provided notice to FOURNIER in accordance
with Sections 7.04 and 7.05 hereof prior to such termination that RGENE desires
to develop the IMPROVEMENT jointly with FOURNIER and has paid to FOURNIER
contemporaneous with its notice the amounts prescribed in such sections.
12.0 ASSIGNMENT
Except as otherwise provided herein, this AGREEMENT may not be assigned
by a PARTY without the prior written consent of the other PARTY except in
connection with the assignment to wholly-owned subsidiaries of such PARTY or to
successors in interests of the business to which this AGREEMENT relates.
13.0 INDEMNITY
13.01 FOURNIER shall, at its cost and expense, defend, indemnify and
hold harmless RGENE, the LICENSORS, and their respective directors, officers,
employees, agents, and AFFILIATE from and against any and all fines, penalties,
damages, and claims imposed, asserted, suffered or made by any PERSON as a
result of FOURNIER's failure to comply with any term or provision of this
AGREEMENT, including, without limitation, contamination or improper storage by
FOURNIER or its AFFILIATES or sublicensees of any LICENSED E1A PRODUCT;
provided, however, that the foregoing indemnity shall not apply to the extent
that any such fines, penalties, damages, or claims arise out of, are related to,
or are in any way connected with the failure of RGENE to comply with any term or
provision of this AGREEMENT, including without limitation, RGENE's breach of its
agreement to manufacture and deliver to FOURNIER the LICENSED E1A PRODUCT in
accordance with Sections 4.03(B) and 5.01 hereof. The foregoing exclusion of the
indemnity shall apply only with respect to RGENE, and such indemnity shall
remain in force with respect to the LICENSORS and their respective officers,
directors, employees, and agents, except to the extent that such fines,
penalties, damages, or claims arose from the negligence, recklessness or willful
misconduct of the LICENSORS or any of their respective officers, directors,
employees, or agents.
13.02 RGENE shall, at its cost and expense, defend, indemnify and hold
harmless FOURNIER and its directors, officers, employees, agents, and AFFILIATES
from and against any and all fines, penalties, damages, and claims
-32-
35
imposed, asserted, suffered or made by any PERSON as a result of (A) any
LICENSED E1A PRODUCT manufactured, marketed, sold, or delivered by or on behalf
of RGENE or its AFFILIATES, sublicensees, or subcontractors, (B) the
manufacture, packaging, storage, or shipment of any LICENSED E1A PRODUCT by or
on behalf of RGENE or its AFFILIATES, sublicensees, or subcontractors, (C) any
use of any LICENSED E1A PRODUCT by any PERSON, including, without limitation,
products liability, (D) any act, commitment, or omission by RGENE or its
AFFILIATES, sublicensees, or subcontractors, and (E) any failure by RGENE or its
AFFILIATES, sublicensees, or subcontractors to comply with any term or provision
of this AGREEMENT, including, without limitation, RGENE's breach of its
agreement to manufacture and deliver to FOURNIER the LICENSED E1A PRODUCT in
accordance with Sections 4.03(B) and 5.01 hereof; provided, however, that the
foregoing indemnity shall not apply to the extent that any such fines,
penalties, damages, or claims arise out of an act or omission of FOURNIER,
including, without limitation, a breach by FOURNIER or its AFFILIATES or
sublicensees of Section 4.01 hereof.
14.0 MISCELLANEOUS PROVISIONS
14.01 Duties and Taxes
FOURNIER shall be responsible for any import duties and taxes associated
with the supply, shipment, or sale of LICENSED E1A PRODUCT, as well as
compliance with all applicable foreign laws and regulations.
14.02 Notices
(A) All communications and notices provided for under this
AGREEMENT shall be in writing and be given personally, by courier, or by means
of telex, telecopy or other wire transmission (with provision for assurance of
receipt in a manner typical with respect to communications of that type), or be
mailed by registered or certified first class mail, return receipt requested, at
the address set forth below (or to such other PERSON, address or telecopy (FAX)
number as a PARTY may, from time to time, designate by written notice):
(i) If to RGENE:
RGENE Therapeutics, Inc.
2170 Buckthorne Place, #230
The Woodlands, Texas 77380 U.S.A.
Attention: Dr. Marin H. Lindenberg
FAX: (713) 367-1661
-33-
36
With a copy to:
Morgan & Finnegan, L.L.P.
345 Park Avenue
New York, New York 10154
Attention: Kenneth H. Sonnenfeld, Esq.
FAX: (212) 751-6849;
(ii) If to Fournier:
Laboratoires Fournier S.C.A.
42, rue de Longvic
21300 Chenove
France
Attention: Mr. Bernard Majoie
FAX: (33) 80-44-70-04
With a copy to:
Cadwalader, Wickersham & Taft
100 Maiden Lane
New York, New York 10038
Attention: Peter G. Bergmann, Esq.
FAX: (212) 504-6666.
(B) All such communications and notices given in such manner
shall be deemed given when received by (or when proffered to, if receipt is
refused) the PARTY or PERSON to whom it is addressed.
14.03 Waiver
No failure or delay by any PARTY to insist upon the strict performance of
any term, provision, condition, covenant, or agreement contained in this
AGREEMENT, or to exercise any right, power, or remedy under or consequent upon a
breach of this AGREEMENT shall constitute a waiver of any such term, provision,
condition, covenant, agreement, right, power, or remedy or of any such breach,
or preclude such PARTY from exercising any such right, power, or remedy at any
later time or times.
14.04 Governing Law
Any dispute between the PARTIES arising out of or with regard to any term
or provision of this AGREEMENT, including, without limitation, its construction,
interpretation, breach, and damages for breach, shall be governed by the laws of
the
-34-
37
State of New York (without regard to its conflict of law principles). Each of
the PARTIES consents to personal jurisdiction in the State of New York for
purposes of any such dispute, and any suit or claim arising out of such dispute
shall be brought only in the courts of the State of New York or the Federal
Court of the United States, located in the Borough of Manhattan, County of New
York.
14.05 Counterparts
This AGREEMENT may be executed in one or more counterparts, each of which
shall be deemed to be an original but all of which together shall constitute one
and the same AGREEMENT. A facsimile signed copy of this AGREEMENT shall be
deemed valid as between the PARTIES.
14.06 Headings
The headings and divisions of this AGREEMENT are intended solely for
convenience of reference and shall be given no effect in the construction or
interpretation of this AGREEMENT.
14.07 Entire Understanding
This AGREEMENT constitutes the entire understanding between the PARTIES
with respect to the subject matter hereof. No modifications, extensions, or
waivers of any provisions hereof or release of any right hereunder shall be
valid, unless the same is in writing and is consented to by both PARTIES.
14.08 Further Assurances
Each of the PARTIES shall, at the request of the other PARTY, execute and
deliver, or have executed and delivered, all such further assignments,
endorsements, and other documents, and perform all such other acts as may
reasonably be necessary to accomplish the transactions contemplated by this
AGREEMENT.
14.09 Severability
If any provision of this AGREEMENT is held to be unenforceable for any
reason, it shall be adjusted rather than voided, if possible, in order to
achieve the intent of the PARTIES. In any event, all other provisions of this
AGREEMENT shall be deemed valid and enforceable to the full extent permitted by
law.
-35-
38
14.10 Force Majeure
Neither PARTY shall be liable for failure to perform as required by any
provision of this AGREEMENT where such failure results from a force majeure,
including, without limitation, any order of a GOVERNMENTAL AUTHORITY beyond such
PARTY's control. In the event of any delay attributable to a force majeure, the
time for performance affected thereby shall be extended for a period equal to
the time lost by reason of such delay. If, as a result of a force majeure, RGENE
is unable to manufacture LICENSED E1A PRODUCT for the purposes of this
AGREEMENT, and strictly in accordance with Section 5.01 hereof, then FOURNIER
shall have the right, but not the obligation, to manufacture said LICENSED E1A
PRODUCT.
14.11 Relationship of the PARTIES
This AGREEMENT shall not be construed as constituting either PARTY as a
partner of the other or to create any other form of legal association that would
impose liability upon one PARTY for the act or omission of the other PARTY or as
providing either PARTY with the right, power, or authority to create or impose
any duty or obligation upon the other PARTY.
14.12 Successors and Assigns
This AGREEMENT shall be binding upon, and inure to the benefit of, each of
RGENE and FOURNIER and their respective successors and permitted assigns.
14.13 Expenses
Each of the PARTIES shall bear its respective costs and expenses (including
attorneys' fees and expenses) incurred in connection with the negotiation and
preparation of this AGREEMENT and consummation of the transactions contemplated
hereby.
15.0 REPRESENTATIONS AND WARRANTIES
15.01 Representations and Warranties of RGENE
RGENE hereby represents and warrants to FOURNIER that, as of the date of
this AGREEMENT, the following statements are and shall be true and correct in
all material respects:
(A) Organization and Good Standing. RGENE is a corporation duly
organized, validly existing, and in good standing under the laws of
-36-
39
the State of Delaware, has the corporate power and authority to conduct the
business in which it presently is engaged, to enter into this AGREEMENT, and to
perform its obligations hereunder, is qualified to do business as a foreign
corporation, and is in good standing in each jurisdiction in which the failure
to be so qualified would have a material adverse effect upon its business or
financial condition.
(B) Authorization and Binding Effect. All corporate action on the
part of RGENE and its officers and directors necessary for the authorization,
execution, and delivery of this AGREEMENT and for the performance of all of
RGENE's obligations hereunder has been taken, and this AGREEMENT, when executed
and delivered, shall constitute a valid and legally binding obligation of RGENE
enforceable against RGENE in accordance with its terms, except as enforceability
may be limited by bankruptcy, insolvency, and other laws affecting creditors'
rights generally or by general equitable principles.
(C) Execution, Delivery and Performance. The execution, delivery,
and performance by RGENE of this AGREEMENT do not (i) violate or breach the
certificate of incorporation or bylaws of RGENE, (ii) violate or conflict with
any applicable law, (iii) violate, breach, cause a default under, or otherwise
give rise to a right of termination, cancellation or acceleration with respect
to (presently, with the giving of notice or the passage of time), any agreement,
contract or instrument to which RGENE is a party or by which any of its assets
are bound, or (iv) result in the creation or imposition of any lien, pledge,
mortgage, claim, charge, or encumbrance upon any assets of RGENE.
(D) Governmental and Other Consents. No consent, authorization,
license, permit, registration or approval of, or exemption or other action by,
any governmental authority or any PERSON other than the UTRC and the BOARD is
required in connection with RGENE's execution and delivery of this AGREEMENT.
(E) Disclosure. To the best of RGENE's knowledge, no
representation or warranty by RGENE contained in this AGREEMENT and no writing,
certificate, exhibit, list, information, document or other instrument furnished
pursuant to this AGREEMENT contain or will contain any untrue statement of a
material fact or omit or will omit any material fact so as to make any statement
or information contained therein misleading.
(F) Intellectual Property. RGENE (i) has delivered to FOURNIER
all information in RGENE's possession or of which RGENE has knowledge concerning
the patent applications that are the subject of this AGREEMENT and the LICENSED
PATENT RIGHTS; (ii) has no knowledge that
-37-
40
the practice of the LICENSED PATENT RIGHTS would infringe any presently existing
patent; (iii) except as disclosed to FOURNIER on Appendix C hereto, has no
knowledge of any objection or proceeding, pending or threatened, that would
affect the validity of any patent issued pursuant to this AGREEMENT; and (iv)
has furnished to FOURNIER all prior art form, of which it presently has
knowledge, that is material to the validity of the patent claims being
prosecuted in the applications which are licensed to FOURNIER under this
AGREEMENT. RGENE does not have knowledge of any presently existing patents in
the United States or the LICENSED TERRITORY that would be infringed by the
activity contemplated by this AGREEMENT. The representations and warranties of
RGENE as set forth in Section 2.14 of the Agreement and Plan of Merger among
Targeted Genetics Corporation, TGC Acquisition Corporation, and RGene
Therapeutics, Inc. dated as of April 16, 1996, including Schedule 2.14 of the
Company Disclosure Memorandum (as that term is defined in said Agreement and
Plan of Merger), (i) are incorporated herein by reference to the extent that
they relate to the LICENSED E1A SUBJECT MATTER or the LICENSED CATIONIC LIPID
SUBJECT MATTER, (ii) to such extent, shall constitute representations and
warranties under this AGREEMENT, and (iii) are and shall be true and correct in
all respects as of the date of this AGREEMENT. Said Section 2.14 and Schedule
2.14 are attached hereto as Appendix D.
15.02 Representations and Warranties of FOURNIER
FOURNIER hereby represents and warrants to RGENE that, as of the date of
this AGREEMENT, the following statements are and shall be true and correct in
all material respects:
(A) Organization and Good Standing. FOURNIER is a corporation
duly organized, validly existing, and in good standing under the laws of France
and has the corporate power and authority to conduct the business in which it
presently is engaged, to enter into this AGREEMENT, and to perform its
obligations hereunder, is qualified to do business as a foreign corporation, and
is in good standing in each jurisdiction in which the failure to be so qualified
would have a material adverse effect upon its business or financial condition.
(B) Authorization and Binding Effect. All corporate action on the
part of FOURNIER and its officers and directors necessary for the authorization,
execution, and delivery of this AGREEMENT and for the performance of all of
FOURNIER's obligations hereunder has been taken, and this AGREEMENT, when
executed and delivered, shall constitute a valid and legally binding obligation
of FOURNIER enforceable against FOURNIER in accordance with its terms, except as
-38-
41
enforceability may be limited by bankruptcy, insolvency, or other laws affecting
creditors' rights generally or by general equitable principles.
(C) Execution, Delivery and Performance. The execution, delivery,
and performance by FOURNIER of this AGREEMENT do not (i) violate or breach the
certificate of incorporation or bylaws of FOURNIER, (ii) violate or conflict
with any applicable law, (iii) violate, breach, cause a default under, or
otherwise give rise to a right of termination, cancellation or acceleration with
respect to (presently, with the giving of notice or the passage of time), any
agreement, contract or instrument to which FOURNIER is a party or by which any
of its assets are bound, or (iv) result in the creation or imposition of any
lien, pledge, mortgage, claim, charge, or encumbrance upon any assets of
FOURNIER.
(D) Governmental and Other Consents. No consent, authorization,
license, permit, registration or approval of, or exemption or other action by,
any governmental authority or any other PERSON is required in connection with
FOURNIER's execution and delivery of this AGREEMENT.
(E) Disclosure. To the best of FOURNIER's knowledge, no
representation or warranty by FOURNIER contained in this AGREEMENT and no
writing, certificate, exhibit, list, information, document or other instrument
furnished pursuant to this AGREEMENT contain or will contain any untrue
statement of a material fact or omit or will omit any material fact so as to
make any statement or information contained therein misleading.
15.03 Survival
The respective representations and warranties of the PARTIES shall
survive any termination of this AGREEMENT.
IN WITNESS WHEREOF, the PARTIES hereto have executed this AGREEMENT as
of the date and year first written above.
RGENE THERAPEUTICS, INC. LABORATOIRES FOURNIER S.C.A.
By: /s/ Martin H. Lindenberg By: /s/ Francois Picart
------------------------ -----------------------------------
Name: Martin H. Lindenberg Name: Francois Picart
Title: President and CEO Title: Vice President, Legal Department
-39-
42
APPENDIX A
This AGREEMENT extends to patent rights and know-how in the LICENSED
TERRITORIES listed below:
France Liechtenstein
Germany San Marino
Italy Vatican
Belgium Poland
Luxembourg Czech Republic
Netherlands Slovakia
United Kingdom Hungary
Ireland Macedonia
Denmark Romania
Greece Bulgary
Spain Slovenia
Portugal Croatia
Austria Bosnia
Sweden Serbia
Finland Albania
Switzerland Montenegro
Turkey Latvia
Iceland Estonia
Norway Lithuania
Andorra French-speaking countries of Africa
Monaco
-40-
43
APPENDIX B
FOREIGN PATENTS AND PATENT APPLICATIONS
RELATED TO E1A SUBJECT MATTER
==============================================================================================================================
COUNTRY SERIAL NO. PATENT NO. TERMINATION DATE
- ------------------------------------------------------------------------------------------------------------------------------
PCT PCT/US91/09100
- ------------------------------------------------------------------------------------------------------------------------------
France EP 92 902782.9
- ------------------------------------------------------------------------------------------------------------------------------
Germany EP 92 902782.9
- ------------------------------------------------------------------------------------------------------------------------------
Italy EP 92 902782.9
- ------------------------------------------------------------------------------------------------------------------------------
Belgium EP 92 902782.9
- ------------------------------------------------------------------------------------------------------------------------------
Netherlands EP 92 902782.9
- ------------------------------------------------------------------------------------------------------------------------------
United Kingdom EP 92 902782.9
- ------------------------------------------------------------------------------------------------------------------------------
Denmark EP 92 902782.9
- ------------------------------------------------------------------------------------------------------------------------------
Spain EP 92 902782.9
- ------------------------------------------------------------------------------------------------------------------------------
Austria EP 92 902782.9
- ------------------------------------------------------------------------------------------------------------------------------
Sweden EP 92 902782.9
- ------------------------------------------------------------------------------------------------------------------------------
Switzerland EP 92 902782.9
- ------------------------------------------------------------------------------------------------------------------------------
PCT (CIP of PCT/US94/13868
PCT\US 91/09100)
- ------------------------------------------------------------------------------------------------------------------------------
DESIGNATED COUNTRIES OF PCT/US94/13868:
- ------------------------------------------------------------------------------------------------------------------------------
Armenia
- ------------------------------------------------------------------------------------------------------------------------------
Austria
- ------------------------------------------------------------------------------------------------------------------------------
Australia
- ------------------------------------------------------------------------------------------------------------------------------
Barbados
- ------------------------------------------------------------------------------------------------------------------------------
Bulgaria
- ------------------------------------------------------------------------------------------------------------------------------
Brazil
-41-
44
- ---------------------------------------------------------------------------------------------------------------------------
Belarus
- ---------------------------------------------------------------------------------------------------------------------------
Canada
- ------------------------------------------------------------------------------------------------------------------------
Switzerland/Liechtenstein
- ------------------------------------------------------------------------------------------------------------------------
China
- ---------------------------------------------------------------------------------------------------------------------------
Czech Republic
- ---------------------------------------------------------------------------------------------------------------------------
Germany
- ---------------------------------------------------------------------------------------------------------------------------
Denmark
- ---------------------------------------------------------------------------------------------------------------------------
Spain
- ---------------------------------------------------------------------------------------------------------------------------
Finland
- ---------------------------------------------------------------------------------------------------------------------------
United Kingdom
- ---------------------------------------------------------------------------------------------------------------------------
Georgia
- ---------------------------------------------------------------------------------------------------------------------------
Hungary
- ---------------------------------------------------------------------------------------------------------------------------
Japan
- ---------------------------------------------------------------------------------------------------------------------------
Kenya
- ---------------------------------------------------------------------------------------------------------------------------
Kyrgyzstan
- ---------------------------------------------------------------------------------------------------------------------------
Democratic People's Republic of Korea
- ---------------------------------------------------------------------------------------------------------------------------
Republic of Korea
- ---------------------------------------------------------------------------------------------------------------------------
Kazakhstan
- ---------------------------------------------------------------------------------------------------------------------------
Sri Lanka
- ---------------------------------------------------------------------------------------------------------------------------
Lithuania
- ---------------------------------------------------------------------------------------------------------------------------
Luxembourg
- ---------------------------------------------------------------------------------------------------------------------------
Latvia
- ---------------------------------------------------------------------------------------------------------------------------
Republic of Moldova
- ---------------------------------------------------------------------------------------------------------------------------
Madagascar
- ---------------------------------------------------------------------------------------------------------------------------
Mongolia
- ---------------------------------------------------------------------------------------------------------------------------
Malawi
- ---------------------------------------------------------------------------------------------------------------------------
Netherlands
-42-
45
- ---------------------------------------------------------------------------------------------------------------------------
Norway
- ---------------------------------------------------------------------------------------------------------------------------
New Zealand
- ---------------------------------------------------------------------------------------------------------------------------
Poland
- ---------------------------------------------------------------------------------------------------------------------------
Portugal
- ---------------------------------------------------------------------------------------------------------------------------
Romania
- ---------------------------------------------------------------------------------------------------------------------------
Russian Federation
- ---------------------------------------------------------------------------------------------------------------------------
Sudan
- ---------------------------------------------------------------------------------------------------------------------------
Sweden
- ---------------------------------------------------------------------------------------------------------------------------
Slovenia
- ---------------------------------------------------------------------------------------------------------------------------
Slovakia
- ---------------------------------------------------------------------------------------------------------------------------
Tajikistan
- ---------------------------------------------------------------------------------------------------------------------------
Trinidad
- ---------------------------------------------------------------------------------------------------------------------------
Ukraine
- ---------------------------------------------------------------------------------------------------------------------------
Uzbekistan
- ---------------------------------------------------------------------------------------------------------------------------
Viet Nam
- ---------------------------------------------------------------------------------------------------------------------------
ARIPO PATENT: Kenya, Malawi, Sudan and Swaziland.
- -------------------------------------------------------------------------------------------------------------------
EUROPEAN PATENT: Austria, Belgium, Switzerland/Liechtenstein, Germany, Denmark,
Spain, France, United Kingdom, Greece, Ireland, Italy, Luxembourg, Monaco,
Netherlands, Portugal and Sweden.
- -------------------------------------------------------------------------------------------------------------------
OAPI PATENT: Burkina Faso, Benin, Central African Republic, Congo, Cote
d'Ivoire, Cameroon, Gabon, Guinea, Mali, Mauritania, Niger, Senegal, Chad and
Togo.
===================================================================================================================
-43-
46
APPENDIX B, CONT.
FOREIGN PATENTS AND PATENT APPLICATIONS
RELATED TO CATIONIC LIPID SUBJECT MATTER
===============================================================================================================================
COUNTRY SERIAL NO. PATENT NO. TERMINATION DATE
- -------------------------------------------------------------------------------------------------------------------------------
PCT PCT/US92/07290
- -------------------------------------------------------------------------------------------------------------------------------
France EP 92 920321.4
- -------------------------------------------------------------------------------------------------------------------------------
Germany EP 92 920321.4
- -------------------------------------------------------------------------------------------------------------------------------
Italy EP 92 920321.4
- -------------------------------------------------------------------------------------------------------------------------------
Belgium EP 92 920321.4
- -------------------------------------------------------------------------------------------------------------------------------
Luxembourg EP 92 920321.4
- -------------------------------------------------------------------------------------------------------------------------------
Netherlands EP 92 920321.4
- -------------------------------------------------------------------------------------------------------------------------------
United Kingdom EP 92 920321.4
- -------------------------------------------------------------------------------------------------------------------------------
Denmark EP 92 920321.4
- -------------------------------------------------------------------------------------------------------------------------------
Greece EP 92 920321.4
- -------------------------------------------------------------------------------------------------------------------------------
Spain EP 92 920321.4
- -------------------------------------------------------------------------------------------------------------------------------
Austria EP 92 920321.4
- -------------------------------------------------------------------------------------------------------------------------------
Sweden EP 92 920321.4
- -------------------------------------------------------------------------------------------------------------------------------
Switzerland/ EP 92 920321.4
Liechtenstein
- -------------------------------------------------------------------------------------------------------------------------------
Monaco EP 92 920321.4
===============================================================================================================================
-44-
47
APPENDIX C
Third-party observations regarding prior art have been filed with the
European Patent Office in connection with European Patent Application No. EP 92
920321.4 relating to the LICENSED CATIONIC LIPID SUBJECT MATTER.
-45-
48
APPENDIX D
employee benefit plan, policy, program, practice, contract or arrangement
currently (or previously) maintained or contributed to by any ERISA Affiliate.
(j) Payments Resulting From Transactions. Except as set forth
in Schedule 2.13 to the Company Disclosure Memorandum, the consummation of any
transaction contemplated by this Agreement will not result in any (i) payment
(whether of severance pay or otherwise) becoming due from the Company to any
officer, employee, former employee or director thereof or to the trustee under
any "rabbi trust" or similar arrangement; (ii) benefit under any Employee
Benefit Plan of the Company being established or becoming accelerated, vested or
payable; or (iii) payment or series of payments by the Company, directly or
indirectly, to any person that would constitute a "parachute payment" within the
meaning of Section 280G of the Code.
2.14 PATENTS, TRADEMARKS, ETC.
Set forth on Schedule 2.14 to the Company Disclosure Memorandum is a
true and complete list of all patents, trademarks, service marks, trade names,
brand names, and registered copyrights, and any applications for any of the
foregoing (collectively, the "Company Intellectual Property") of any kind used
now or within the two (2) year period immediately preceding the date of this
Agreement in the business of the Company. Such Schedule 2.14 contains a complete
and accurate list of all licenses or agreements that in any way affect the
rights of the Company to any of the Company Intellectual Property or any trade
secret material to the Company (the "Company Intellectual Property Licenses").
No claim with respect to the Company Intellectual Property, any trade secret
material to the Company, or any Company Intellectual Property License is
currently pending or, to the best knowledge of the Company, overtly threatened
by any Person, nor does the Company know of any valid grounds for any bona fide
claim, except as set forth on such Schedule 2.14, (a) to the effect that any
Company operation, Company Intellectual Property, trade secret material to the
Company, or Company Intellectual Property License infringes or misappropriates
any copyright, patent, trademark, service mark or trade secret; (b) to the
effect that any other Person infringes on the Company Intellectual Property or
misappropriates any trade secret material to the Company; (c) challenging the
ownership, validity or effectiveness of any of the Company Intellectual Property
or trade secret material to the Company; or (d) challenging the Company's
license under, or other legally enforceable right under, any Company
Intellectual Property License. The consummation of the transactions contemplated
hereby will not alter or impair the Company's rights to any of the Company
Intellectual Property, any trade secret material to the Company or under any
Company Intellectual Property License. With respect to any Company Intellectual
Property or trade secret material to the Company, the Company owns or has the
right to use such Company Intellectual Property or trade secret in its business.
Except as set forth on such Schedule 2.14 in respect of the Company Intellectual
Property Licenses or otherwise, and except where the failure to so own or be
49
licensed would not have a Material Adverse Effect upon the Company, the Company
is the sole and exclusive owner or the exclusive licensee pursuant to the
Company Intellectual Property Licenses of the Company Intellectual Property.
Except as set forth on such Schedule 2.14, each of the Company
Intellectual Property Licenses is valid, binding and enforceable in accordance
with its terms against the parties thereto; the Company has performed all
obligations imposed upon it under each of the Company Intellectual Property
Licenses; and neither the Company nor any other party thereto is in default
thereunder, nor, to the Company's best knowledge, is there any event that with
notice or lapse of time, or both, would constitute a default thereunder. Except
as set forth on such Schedule 2.14, the Company has not received notice that any
party to any of the Company Intellectual Property Licenses intends to cancel,
terminate or refuse to renew the same or to exercise or decline to exercise any
option or other right thereunder. Except as set forth on such Schedule 2.14, no
licenses, sublicenses, covenants or agreements have been granted or entered into
by the Company in respect of any of the Company Intellectual Property or any
trade secret material to the Company except the Company Intellectual Property
Licenses. No director, officer, Stockholder or employee of the Company owns,
directly or indirectly, in whole or in part, any of the Company Intellectual
Property or any trade secret material to the Company. To the Company's best
knowledge, none of the Company's officers, employees, consultants, distributors,
agents, representatives or advisors have entered into any agreement relating to
the Company's business regarding know-how, trade secrets, assignment of rights
in inventions, or prohibition or restriction of competition or solicitation of
customers, or any other similar restrictive agreement or covenant, whether
written or oral, with any Person other than the Company.
Except as set forth on such Schedule 2.14, to the Company's best
knowledge, no Person has asserted any claim of infringement or other
interference with third-party rights with respect to the Company Intellectual
Property or any trade secret material to the Company. Except as set forth on
such Schedule 2.14, (a) during the two (2) year period immediately preceding the
date of this Agreement, the Company has not disclosed other than in the ordinary
course consistent with past practice any proprietary information relating to the
Company Intellectual Property, any trade secret material to the Company or the
Company Intellectual Property Licenses to any person other than to Targeted or
Acquisition; (b) the Company has at all times maintained reasonable procedures
to protect and have enforced all trade secrets of the Company; (c) the Company
has disclosed trade secrets to other Persons solely as required for the conduct
of the Company's business and solely under nondisclosure agreements that are
enforceable by the Company and, upon the Closing, will be enforceable by
Acquisition or Targeted in accordance with their terms; and (d) the Company is
not under any contractual or other obligation to disclose any proprietary
information relating to the Company Intellectual Property, any trade secret
material to the Company or the Company Intellectual Property Licenses except
pursuant to the nondisclosure agreements listed on such Schedule 2.14,
-2-
50
nor, to the best knowledge of the Company, is any other party to the Company
Intellectual Property Licenses under any such obligation to disclose proprietary
information included in or relating to Company Intellectual Property, any trade
secret material to the Company or the Company Intellectual Property Licenses to
any person or entity, and no event has taken place, including the execution of
this Agreement or any related change in the Company's business activities, that
would give rise to such obligation.
2.15 CORPORATE BOOKS AND RECORDS
The Company has furnished to Targeted or its representatives for their
examination true and complete copies of (a) the Certificate of Incorporation and
Bylaws of the Company as currently in effect, including all amendments thereto,
(b) the minute books of the Company, and (c) the stock transfer books of the
Company. Such minutes reflect all meetings of the Company's Stockholders, Board
of Directors and any committees thereof since the Company's inception, and such
minutes accurately reflect in all material respects the events of and actions
taken at such meetings. Such stock transfer books accurately reflect all
issuances and transfers of shares of capital stock of the Company since its
inception.
2.16 LICENSES, PERMITS, AUTHORIZATIONS, ETC.
Except as identified in Schedules 2.1 and 2.5 to the Company Disclosure
Memorandum and except where the failure to have any of the following would not
result in a Material Adverse Effect, the Company has received all governmental
approvals, authorizations, consents, licenses, orders, registrations and permits
of all agencies, whether federal, state, local or foreign that are currently
required in order for the Company to conduct its business as it is currently
conducted. The Company has not received any notifications of any asserted
present failure by it to have obtained any such governmental approval,
authorization, consent, license, order, registration or permit, or past and
unremedied failure to obtain such items.
2.17 COMPLIANCE WITH LAWS
Except as described on Schedule 2.17 to the Company Disclosure
Memorandum and except where the failure to have any of the following would not
result in a Material Adverse Effect, the Company has at all times complied, and
is in compliance, with all federal, state, local and foreign laws, rules,
regulations, ordinances, decrees and orders applicable to it, to its employees,
or to the Company
-3-
51
SCHEDULE 2.11
CLAIMS AND LEGAL PROCEEDINGS
No pending litigation.
Third-party observations regarding prior art have been filed with the
European Patent Office in connection with the DC-Cholesterol licensed from The
University of Tennessee Research Corporation, as identified in the attached
correspondence. Similarly, an opposition has been filed in response to the
granting of a patent by the Australian patent office for this technology.
See Schedule 2.10, Contracts, item 1 under the heading "Scientific
Collaboration Agreements" for information regarding the Theragen, Inc. release.
52
SCHEDULE 2.14
PATENTS, TRADEMARKS, ETC.
==================================================================================================================================
PATENT NO.
ISSUE DATE INVENTOR
EXPIRATION TITLE LAW FIRM
DATE APPLICATION SERIAL NO. CONTACT DESCRIPTION &
ASSIGNEE FILING DATE COUNTRY DOCKET NO. STATUS
==================================================================================================================================
[*] [*] [*] [*] [*]
- ----------------------------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
- ----------------------------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
- ----------------------------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
- ----------------------------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
- ----------------------------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
- ----------------------------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
- ----------------------------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
- ----------------------------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
- ----------------------------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
- ----------------------------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
- ----------------------------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
- ----------------------------------------------------------------------------------------------------------------------------------
Pat No.: 5,417,978 Inventor(s): Ana Tari, Gabriel U.S.A. Law Firm: Description: Lipid delivered
Lopez-Berestein and Albert Arnold, White & antisense for CML
Issue Date: 5/23/95 Deisseroth Durkee
Status: Issued. PCT filed 7/29/94
Expiration Date: Title: Liposomal Antisense Contact:
Methyl Phosphonate Ken Goodman
Assignee: Oligonucleotides & Methods for
Board of Regents, their Preparation & Use Docket No:
The University of UTFC: 346/GOO
Texas System Serial No: 08/099,229
Filing Date: 07/29/93
- ----------------------------------------------------------------------------------------------------------------------------------
Pat No.: Inventor(s): Ana Tari, Gabriel PCT Law Firm: Description: Lipid delivered
Lopez-Berestein and Albert Arnold, White & antisense for CML
Issue Date: Deisseroth Durkee
Status: Nationalized into
Expiration Date: Title: Liposomal Antisense Contact: Australia, Canada, European
Methyl Phosphonate Ken Goodman Patent Office and Japan.
Assignee: Oligonucleotides & Methods for
Board of Regents, their Preparation & Use Docket No:
The University of UTFC 346/GOO
Texas System Serial No: PCT/US94/08568
Filing Date: 07/29/94
- ----------------------------------------------------------------------------------------------------------------------------------
- --------
* Confidential Treatment Requested
-2-
53
==================================================================================================================================
PATENT NO.
ISSUE DATE INVENTOR
EXPIRATION TITLE LAW FIRM
DATE APPLICATION SERIAL NO. CONTACT DESCRIPTION &
ASSIGNEE FILING DATE COUNTRY DOCKET NO. STATUS
==================================================================================================================================
Pat No.: Inventor(s): Ana Tari, Gabriel Australia Law Firm: Description: Lipid delivered
Lopez-Berestein and Albert Arnold, White & antisense for CML
Issue Date: Deisseroth Durkee
Status: Pending.
Expiration Date: Title: Liposomal Antisense Contact:
Methyl Phosphonate Ken Goodman
Assignee: Oligonucleotides & Methods for
Board of Regents, their Preparation & Use Docket No:
The University of UTFC: 346-AU
Texas System Serial No: 74079/94
Filing Date: 02/02/96
- ----------------------------------------------------------------------------------------------------------------------------------
Pat No.: Inventor(s): Ana Tari, Gabriel Canada Law Firm: Description: Lipid delivered
Lopez-Berestein and Albert Arnold, White & antisense for CML
Issue Date: Deisseroth Durkee
Status: Pending.
Expiration Date: Title: Liposomal Antisense Contact:
Methyl Phosphonate Ken Goodman
Assignee: Oligonucleotides & Methods for
Board of Regents, their Preparation & Use Docket No:
The University of UTFC: 346-CA
Texas System Serial No: 2168243
Filing Date: 01/26/96
- ----------------------------------------------------------------------------------------------------------------------------------
Pat No.: Inventor(s): Ana Tari, Gabriel European Law Firm: Description: Lipid delivered
Lopez-Berestein and Albert Patent Arnold, White & antisense for CML
Issue Date: Deisseroth Office Durkee
Status: Pending.
Expiration Date: Title: Liposomal Antisense Contact:
Methyl Phosphonate Ken Goodman
Assignee: Oligonucleotides & Methods for
Board of Regents, their Preparation & Use Docket No:
The University of UTFC: 346E-
Texas System Serial No: 94924066.7
Filing Date: 02/28/96
- ----------------------------------------------------------------------------------------------------------------------------------
Pat No.: Inventor(s): Ana Tari, Gabriel Japan Law Firm: Description: Lipid delivered
Lopez-Berestein and Albert Arnold, White & antisense for CML
Issue Date: Deisseroth Durkee
Status: Pending.
Expiration Date: Title: Liposomal Antisense Contact:
Methyl Phosphonate Ken Goodman
Assignee: Oligonucleotides & Methods for
Board of Regents, their Preparation & Use Docket No:
The University of UTFC: 346-JP
Texas System Serial No: 505991/95
Filing Date: 01/29/96
- ----------------------------------------------------------------------------------------------------------------------------------
-3-
54
==================================================================================================================================
PATENT NO.
ISSUE DATE INVENTOR
EXPIRATION TITLE LAW FIRM
DATE APPLICATION SERIAL NO. CONTACT DESCRIPTION &
ASSIGNEE FILING DATE COUNTRY DOCKET NO. STATUS
==================================================================================================================================
[*] [*] [*] [*] [*]
- ----------------------------------------------------------------------------------------------------------------------------------
Pat No.: Inventor(s): Mien-Chie Hung, Di- PCT Law Firm: Description: E1A as a tumor
Hua Yu Angabin Matin & Jujiao Arnold, White & suppressor (for HER-2/neu)
Issue Date: Joe Zhang Durkee
Status: Nationalized into
Expiration Date: Title: Methods & Compositions Contact: Australia, Canada, Europe and
for the Suppression of Neu Mark Wilson Japan.
Assignee: Mediated Transformation
Board of Regents, Docket No:
The University of Serial No: PCT/US91/09100 UTFC: 256PCT
Texas System
Filing Date: 12/4/91
- ----------------------------------------------------------------------------------------------------------------------------------
Pat No.: Inventor(s): Mien-Chie Hung, Di- Australia Law Firm: Description: E1A as a tumor
Hua Yu Angabin Matin & Jujiao Arnold, White & suppressor (for HER-2/neu)
Issue Date: 11/15/94 Joe Zhang Durkee
Status: Patent issued 11/15/94
Expiration Date: Title: Methods & Compositions Contact:
2/04/07 for the Suppression of Neu Mark Wilson
Mediated Transformation
Assignee: Docket No:
Board of Regents, Serial No: 91469/91 UTFC: 256AU
The University of
Texas System Filing Date: 05/18/93
- ----------------------------------------------------------------------------------------------------------------------------------
Pat No.: Inventor(s): Mien-Chie Hung, Di- Canada Law Firm: Description: E1A as a tumor
Hua Yu Angabin Matin & Jujiao Arnold, White & suppressor (for HER-2/neu)
Issue Date: Joe Zhang Durkee
Status: Pending. Requested
Expiration Date: Title: Methods & Compositions Contact: Examination.
for the Suppression of Neu Mark Wilson
Assignee: Mediated Transformation
Board of Regents, Docket No:
The University of Serial No: 2,096,723 UTFC: 346-CA
Texas System
Filing Date: 01/26/96
- ----------------------------------------------------------------------------------------------------------------------------------
Pat No: Inventor(s): Mien-Chie Hung, Di- Europe Law Firm: Description: E1A as a tumor
Hua Yu Angabin Matin & Jujiao Arnold, White & suppressor (for HER-2/neu)
Issue Date: Joe Zhang Durkee
Status: Claims allowed by EPO,
Expiration Date: Title: Methods & Compositions Contact: formalizing patent in individual
for the Suppression of Neu Mark Wilson European countries.
Assignee: Mediated Transformation
Board of Regents,
The University of Serial No: 92,902,782.9 Docket No:
Filing Date: 07/01/93 UTFC: 256EP
- ----------------------------------------------------------------------------------------------------------------------------------
- --------
* Confidential Treatment Requested
-4-
55
==================================================================================================================================
PATENT NO.
ISSUE DATE INVENTOR
EXPIRATION TITLE LAW FIRM
DATE APPLICATION SERIAL NO. CONTACT DESCRIPTION &
ASSIGNEE FILING DATE COUNTRY DOCKET NO. STATUS
==================================================================================================================================
Texas System Filing Date: 07/01/93
- -----------------------------------------------------------------------------------------------------------------------------------
Pat No.: Inventor(s): Mien-Chie Hung, Japan Law Firm: Description: E1A as a tumor
Di-Hua Yu Angabin Matin & Arnold, White & suppressor (for HER-2/neu)
Issue Date: Jujiao Joe Zhang Durkee
Statuts: Pending
Expiration Date: Title: Methods & Compositions Contact:
for the Suppression of Neu Mark Wilson
Assignee: Mediated Transformation
Board of Regents, Docket No.:
The University of Serial No.: 04-502955 UTFC: 256JP
Texas System
Filing Date: 06/4/93
- -----------------------------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
- -----------------------------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
- -----------------------------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
- -----------------------------------------------------------------------------------------------------------------------------------
Pat No.: Inventor(s): Mien-Chie Hung, Di- PCT Law Firm: Description: Use of E1A and
Hua Yu Angabin Matin & Jujiao Arnold, White & SV40 Large T antigen for the
Issue Date: Joe Zhang Durkee repression of Neu
Expiration Date: Title: Methods & Compositions Contact: Status: Pending. Corresponds to
for the Suppression of Neu Mark Wilson U.S. Serial Nos.: 08/162,406 and
Assignee: Mediated Transformation 08/276,359
Board of Regents, Docket No:
The University of Serial No: PCT/US94/13868 UTFC: 416P-
Texas System
Filing Date: 12/2/94
- -----------------------------------------------------------------------------------------------------------------------------------
Pat No.: 5,283,185 Inventor(s): Richard Epand, USA Law Firm: Description: Lipid Gene Delivery
Remo Bottega & Leaf Huang Weiser & Associates System (1st Generation)
Issue Date: 02/1/94
Title: Method for Delivering Contact: Status: Patent Issued 02/01/94
Expiration Date: Nucleic Acids into Cells Gerard Weiser
Assignee: University Serial No: 07/751,873 Docket No:
of Tennessee 372.5830P
Research Corp & Filing Date: 08/28/91
McMaster University
- -----------------------------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
- -----------------------------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
- -----------------------------------------------------------------------------------------------------------------------------------
Pat No: Inventor(s): Richard Epand, PCT Law Firm: Description: Lipid Gene Delivery
Issue Date: Remo Bottega & Leaf Huang Weiser & Associates System (1st Generation)
- -----------------------------------------------------------------------------------------------------------------------------------
- --------
* Confidential Treatment Requested
-5-
56
==================================================================================================================================
PATENT NO.
ISSUE DATE INVENTOR
EXPIRATION TITLE LAW FIRM
DATE APPLICATION SERIAL NO. CONTACT DESCRIPTION &
ASSIGNEE FILING DATE COUNTRY DOCKET NO. STATUS
==================================================================================================================================
Title: Method for Delivering Contact: Status: Nationalized into the
Expiration Date: Nucleic Acids into Cells Gerard Weiser EPO, Japan, Korea, Canada &
Australia
Assignee: University Serial No: PCT/US92/07290 Docket No:
of Tennessee 372.5849PCT
Research Corp & Filing Date: 08/28/92
McMaster University
- -----------------------------------------------------------------------------------------------------------------------------------
Pat No.: Inventor(s): Richard Epand, Japan Law Firm: Description: Lipid Gene Delivery
Remo Bottega & Leaf Huang Weiser & Associates System (1st Generation)
Issue Date:
Title: Method for Delivering Contact: Status: Pending. Request for
Expiration Date: Nucleic Acids into Cells Gerard Weiser examination due August 28, 1998.
Assignee: University Serial No: 5-505302 Docket No:
of Tennessee 372.5979R
Research Corp & Filing Date: 02/24/94
McMaster University
- -----------------------------------------------------------------------------------------------------------------------------------
Pat No.: Inventor(s): Richard Epand, Korea Law Firm: Description: Lipid Gene Delivery
Remo Bottega & Leaf Huang Weiser & Associates System (1st Generation)
Issue Date:
Title: Method for Delivering Contact: Status: Pending. Request for
Expiration Date: Nucleic Acids into Cells Gerard Weiser examination due August 28, 1998.
Assignee: University Serial No: 94/700692 Docket No:
of Tennessee 372.5980R
Research Corp & Filing Date: 02/28/94
McMaster University
- -----------------------------------------------------------------------------------------------------------------------------------
Pat No.: Inventor(s): Richard Epand, Canada Law Firm: Description: Lipid Gene Delivery
Remo Bottega & Leaf Huang Weiser & Associates System (1st Generation)
Issue Date:
Title: Method for Delivering Contact: Status: Pending. Request for
Expiration Date: Nucleic Acids into Cells Gerard Weiser examination due August 28, 1999.
Assignee: University Serial No: 2,116,676 Docket No:
of Tennessee 372.5983R
Research Corp & Filing Date: 02/28/94
McMaster University
- ----------------------------------------------------------------------------------------------------------------------------------
Pat No.: Inventor(s): Richard Epand, Australia Law Firm: Description: Lipid Gene Delivery
Remo Bottega & Leaf Huang Weiser & Associates System (1st Generation)
Issue Date:
Title: Method for Delivering Contact: Status: Pending. Request for
Expiration Date: Nucleic Acids into Cells Gerard Weiser examination was filed on October
19, 1994.
Assignee: University Serial No: 26565/92 Docket No:
- ----------------------------------------------------------------------------------------------------------------------------------
-6-
57
==================================================================================================================================
PATENT NO.
ISSUE DATE INVENTOR
EXPIRATION TITLE LAW FIRM
DATE APPLICATION SERIAL NO. CONTACT DESCRIPTION &
ASSIGNEE FILING DATE COUNTRY DOCKET NO. STATUS
==================================================================================================================================
of Tennessee 372.5992R
Research Corp &
McMaster University
Filing Date: 10/19/94
- ----------------------------------------------------------------------------------------------------------------------------------
Pat No.: Inventor(s): Richard Epand, Europe Law Firm: Description: Lipid Gene Delivery
Remo Bottega & Leaf Huang Weiser & Associates System (1st Generation)
Issue Date:
Title: Method for Delivering Contact: Status: Pending. Designating 14
Expiration Date: Nucleic Acids into Cells Gerard Weiser countries: Austria, Belgium,
Switzerland & Liechtenstein,
Assignee: University Serial No: 92 920321.4 Docket No: Germany, Denmark, Spain,
of Tennessee 372.5993R France, United Kingdom, Greece,
Research Corp & Filing Date: Italy, Luxembourg, Monaco,
McMaster University Netherlands & Sweden
- ----------------------------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
- ----------------------------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
- ----------------------------------------------------------------------------------------------------------------------------------
- --------
* Confidential Treatment Requested
-7-
58
See "Licensing and Related Agreements," "Manufacturing and Regulatory
Consultant Agreements" and "Scientific Collaboration Agreements" as set forth in
Schedule 2.10, Contracts above, for information regarding Intellectual Property
Licenses and a listing of same.
See Schedule 2.11, Claims and Legal Proceedings above, for
correspondence regarding third party observations and oppositions to certain
technology licensed from the University of Tennessee Research Corporation.
No representation is made as to exclusivity of the rights above except
to the extent such exclusivity is expressly set forth in the contract or
agreement setting forth the Company's rights as to Company Intellectual Property
and Company Intellectual Property Licenses.
The University of Texas System, the University of Tennessee Research
Corporation and McMaster University, stockholders of the Company, are owners and
licensors of certain of the Company Intellectual Property as reflected in the
foregoing table.
-2-
59
APPENDIX E
[University of Tennessee Research Corporation Letterhead]
May 22, 1996
Dr. Martin H. Lindenberg, M.D.
President & CEO
RGene Therapeutics, Inc.
2170 Buckthorne Place, Suite 170
The Woodlands, Texas 77380
Dr. Alain Munoz
Vice President, Research Development - Licensing
Laboratoires Fournier S.C.A.
50, Rue de Dijon
F-21121 Daix, France
RE: FIRST AMENDED AND RESTATED LICENSE
AGREEMENT ("AGREEMENT"), EFFECTIVE DECEMBER 8, 1995
BY AND BETWEEN THE UNIVERSITY OF TENNESSEE
RESEARCH CORPORATION ("UTRC") AND RGENE
THERAPEUTICS, INC. ("RGENE")
Dear Drs. Lindenberg and Munoz:
This Consent to Sublicense and Successor Letter Agreement is written at
your request in connection with the contemplated agreement between RGene
Therapeutics, Inc. and Laboratoires Fournier S.C.A. ("FOURNIER").
Under Article 2.5 of the AGREEMENT, RGENE must obtain UTRC's prior
written approval prior to entering into any sublicense agreement. UTRC hereby
consents to RGENE entering into the contemplated agreement with FOURNIER which
includes sublicensing to FOURNIER certain of RGENE's rights licensed from UTRC.
60
Dr. Martin Lindenberg
Dr. Alain Fournier
Page 2
UTRC hereby agrees that in the event that LICENSEE enters into a
written and fully executed sublicense agreement with FOURNIER pursuant to
Article 2.5 of the AGREEMENT, and, subsequent thereto which such sublicense
agreement is in effect, the AGREEMENT with RGENE is terminated, FOURNIER shall,
at its sole option exercisable by written notice to UTRC within sixty (60) days
after termination of the AGREEMENT, have the right to succeed to all of RGENE's
rights and responsibilities under the AGREEMENT as set forth hereinbelow,
provided that:
- - as of the date of termination of the AGREEMENT FOURNIER is not in
default of its obligations under its sublicense agreement with RGENE;
- - FOURNIER shall not assume any liabilities of RGENE to UTRC or succeed
to any claims or right of action of RGENE against UTRC accruing prior
to, or as a result of, said termination of the AGREEMENT; and
- - UTRC shall not assume any liabilities or responsibilities of RGENE to
FOURNIER under the sublicense agreement.
Under the conditions set out herein, UTRC hereby agrees to grant a
license to FOURNIER under European Patent Application No. EP 92920321.4 to allow
FOURNIER to practice under such patent application for the purpose of
manufacturing, using, and selling LICENSED E1A PRODUCT in the LICENSED TERRITORY
in the LICENSED FIELD (as those terms are defined in the above-mentioned
sublicense agreement between FOURNIER and RGENE). UTRC confirms that: (1) the
AGREEMENT WITH LICENSEE is in full force and effect as of the date hereinabove;
and (ii) it has no actual knowledge of present facts or circumstances, including
the contemplated merger with Targeted Genetics Corporation and its wholly-owned
subsidiary, which with the passage of time or otherwise, would cause the
termination of the AGREEMENT.
UTRC has been advised in writing by Aronex Pharmaceuticals, Inc. that
Aronex has no outstanding contract issues with respect to the RGene and UTRC
agreement as referenced in Section 5.18 of Article V (page 52) of the AGREEMENT
AND PLAN OF MERGER AMONG TARGETED GENETICS CORP., TGC ACQUISITION CORPORATION
AND RGENE THERAPEUTICS, INC. dated as of April 16, 1996. Conversely, the UTRC
has no outstanding contract issues that would necessitate modification of UTRC's
existing license agreement with Aronex
61
Dr. Martin Lindenberg
Dr. Alain Fournier
Page 3
Pharmaceuticals, Inc. (formerly Argus Pharmaceuticals, Inc.); provided however,
that nothing in this Consent to Sublicense and Successor Letter Agreement shall
be construed as a restriction on UTRC's freedom to modify at any point in the
future its agreement with Aronex or any other agreement to which UTRC is a
party.
This Consent to Sublicense and Successor Letter Agreement shall take
the place of all previous letters to you on this subject, which are hereby
withdrawn. If this Consent to Sublicense and Successor Letter Agreement is
acceptable to you, please sign the three (3) originals in the space provided
below and return two (2) of such originals to me at the following address:
Ann J. Roberson
President
The University of Tennessee Research Corporation
415 Communications Building
Knoxville, Tennessee 37996-0344
Sincerely,
/s/ Ann J. Roberson
Ann J. Roberson
President
ACCEPTED ON BEHALF OF RGENE
THERAPEUTICS, INC.
By: _____________________________
Dr. Martin Lindenberg
President and CEO
Date: ___________________________
62
Dr. Martin Lindenberg
Dr. Alain Fournier
Page 4
ACCEPTED ON BEHALF OF
LABORATOIRES FOURNIER S.C.A.
By: _____________________________
Dr. Alain Munoz
Vice President, Research Development
- Licensing
Date: ___________________________
63
APPENDIX E
[University of Texas MD Anderson Cancer Center Letterhead]
SUCCESSOR LETTER AGREEMENT
May 23, 1996
Dr. Alain Munoz
Vice President, Research Development - Licensing
Laboratoires Fournier S.C.A.
50, Rue de Dijon
F-21121 Daix, France
RE: PATENT AND TECHNOLOGY LICENSE AGREEMENT
("AGREEMENT"), EFFECTIVE MARCH 1, 1994 BY AND BETWEEN THE
BOARD OF REGENTS ("BOARD") OF THE UNIVERSITY OF
TEXAS SYSTEM ("SYSTEM"), THE UNIVERSITY OF
TEXAS M.D. ANDERSON CANCER CENTER ("MDA"), AND
RGENE THERAPEUTICS, INC. ("LICENSEE")
Dear Mr. Munoz:
This Successor Letter Agreement is written at your request, in
connection with the contemplated agreement between RGene Therapeutics, Inc. and
Laboratoires Fournier S.C.A. ("FOURNIER").
BOARD, SYSTEM and MDA hereby agree that in the event that LICENSEE
enters into a written and fully executed sublicense agreement with FOURNIER
pursuant to Article 4.3 of the AGREEMENT, and, subsequent thereto while such
sublicense agreement is in effect, the AGREEMENT with LICENSEE is terminated,
FOURNIER shall, at its sole option, have the right to succeed to all of
LICENSEE's rights and responsibilities under the AGREEMENT as set forth
hereinbelow, provided, however, that FOURNIER shall not assume any liabilities
of LICENSEE to BOARD, SYSTEM, or MDA accruing prior to, or as a result of, said
termination of the AGREEMENT.
64
Fournier - Successor Letter Agreement
May 23, 1996
Page 2
Under the conditions set out herein, BOARD, SYSTEM, and MDA hereby
agree to grant a license to FOURNIER under European Patent Application No. EP
92- 90-2782.9 to allow FOURNIER to practice under such patent application for
the purpose of manufacturing, using, and selling LICENSED E1A PRODUCT in the
LICENSED TERRITORY in the LICENSED FIELD (as those terms are defined in the
above-mentioned sublicense agreement between FOURNIER and RGENE). BOARD, SYSTEM,
and MDA confirm that: (i) the AGREEMENT with LICENSEE is in full force and
effect as of the date hereinabove; and (ii) they know of no present facts or
circumstances, including the contemplated merger with Targeted Genetics
Corporation and its wholly-owned subsidiary, which, with the passage of time or
otherwise, would cause the termination of the AGREEMENT.
If this Successor Letter Agreement is acceptable to you, please sign
the three (3) originals in the space provided below and return two (2) of such
originals to me at the following address:
William J. Doly
Director, Technology Development
1020 Holcombe, Suite 1495
Houston, Texas 77950
Very truly yours,
William J. Doly
Director, Technology Development
IN WITNESS WHEREOF, parties hereto have caused their duly authorized
representatives to execute this AGREEMENT.
THE UNIVERSITY OF TEXAS BOARD OF REGENTS OF THE
M.D. ANDERSON CANCER CENTER UNIVERSITY OF TEXAS SYSTEM
By /s/ David J. Bachrach By /s/ R.D. Burok
----------------------------------- ----------------------------------
David J. Bachrach R.D. Burok
Executive Vice President Executive Vice Chancellor for
for Administration and Finance Business Affairs
65
Fournier - Successor Letter Agreement
May 23, 1996
Page 3
APPROVED AS TO FORM:
By /s/ Dudley R. Dobie, Jr.
-----------------------------------
Dudley R. Dobie, Jr.
Manager, Intellectual Property
LABORATOIRES FOURNIER S.C.A.
By _____________________________