EXHIBIT 10.20
LICENSE AGREEMENT
This License Agreement ("Agreement") is made effective as of this first
day of December 1997, between VIRUS RESEARCH INSTITUTE, Inc., having a place of
business at 61 Moulton Street, Cambridge, MA 02138, USA (herein referred to as
"LICENSOR") and SmithKline Beecham P.L.C., having a place of business at New
Horizons Court, Brentford, Middlesex TW8 9EP, United Kingdom (herein referred to
as "LICENSEE"),
WITNESSETH THAT:
WHEREAS, LICENSOR is the owner of and/or controls all right, title and
interest in certain patents, identified in Appendix A hereto, and know-how in
the field of Rotavirus; and
WHEREAS, LICENSEE desires to obtain certain worldwide licenses from
LICENSOR under the aforesaid patents and know-how, and LICENSOR is willing to
grant to LICENSEE such licenses;
NOW, THEREFORE, in consideration of the covenants and obligations
expressed herein and intending to be legally bound, and otherwise to be bound by
proper and reasonable conduct, the parties agree as follows:
1. DEFINITIONS
1.01 "AFFILIATE(S)" shall mean any corporation, firm, partnership
or other entity, whether de jure or de facto, which directly
or indirectly owns, is owned by or is under common ownership
with a party to this Agreement to the extent of at least fifty
percent (50%) of the equity (or such lesser percentage which
is the maximum allowed to be owned by a foreign corporation in
a particular jurisdiction) having the power to vote on or
direct the affairs of the entity and any person, firm,
partnership, corporation or other entity actually controlled
by, controlling or under common control with a party to this
Agreement.
1.02 "BLOCKING PATENTS" shall mean patents owned and/or controlled
by THIRD PARTIES which are needed by LICENSEE for the making,
having made, using, having used, importing, offering for sale,
selling or having sold VACCINES
2.
and/or technology owned and/or controlled by THIRD PARTIES
which is necessary for LICENSEE in order to practice the
license(s) granted by LICENSOR hereunder. For the avoidance of
doubt any patents and/or patent applications and/or technology
owned and/or controlled by DynCorp to which LICENSEE may
acquire a licence will be considered for the purpose of this
Agreement as BLOCKING PATENTS.
1.03 "COMBINATION" shall mean VACCINE wherein (a) Rotavirus
antigen(s) is (are) formulated in combination with one or more
additional therapeutically and/or prophylactically active
antigens.
1.04 "FDA" shall mean the United States Food and Drug
Administration.
1.05 "KNOW-HOW" shall mean all present and future technical
information, materials and know-how which relate to (a)
Rotavirus antigen(s) for use in a live attenuated vaccine
against rotavirus which are now and/or at anytime during the
term of this Agreement developed, owned, proprietary to and/or
controlled by LICENSOR and/or to which LICENSOR has otherwise
the right to grant license, which are both secret and
substantial. KNOW-HOW shall include the Rotavirus 89.12 strain
and any other live attenuated Rotavirus strain(s) useful or
necessary for VACCINE, owned and/or controlled by LICENSOR
and/or to which LICENSOR has otherwise the right to grant
license and, without limitation, all chemical,
pharmacological, toxicological, clinical, assay, control and
manufacturing data and any other information relating thereto.
KNOW-HOW shall not include any information, materials and/or
know-how which are generally ascertainable from publicly
available information or which subsequently become publicly
available. KNOW-HOW existing as of the Effective Date is
listed in Appendix B attached hereto which shall, as
appropriate, be updated from time to time. LICENSOR shall
identify KNOW-HOW in writing at the time of disclosure to
LICENSEE.
1.06 "LICENSEE" shall mean SmithKline Beecham P.L.C.
1.07 "LICENSOR" shall mean Virus Research Institute, Inc.
1.08 "MAJOR MARKETS" shall mean the United States of America,
United Kingdom, France, Germany and Italy.
3.
1.09 "NET SALES" shall mean the gross receipts from sales of
VACCINE in the TERRITORY by LICENSEE, its AFFILIATES and/or
sublicensees to THIRD PARTIES under this Agreement after
deducting:
(i) reasonable transportation charges, including insurance;
and
(ii) LICENSEE's costs for syringes and other administration
devices combined with, or contained in, commercial
packaging; and
(iii) sales and excise taxes and duties paid by a selling
party and any other governmental charges imposed upon
the production, importation, use or sale of VACCINE
including, without limitation, contributions and
payments collected by any governmental authorities as
liability provisions and/or made pursuant to
governmental injury compensation schemes; and
(iv) trade, quantity and cash discounts (other than cash
discounts for early payments), commissions and other
customary rebates; and
(v) allowances or credits to customers or charges back from
customers on account of rejection or return of VACCINE
subject to royalty under this Agreement or on account
of retroactive price reductions affecting such VACCINE;
and
(vi) the difference between fifty percent (50%) of the
royalties paid to THIRD PARTIES as referred to in
Paragraph 4.02 and the amount of royalties actually
deducted under Paragraph 4.02; and
(vii) the royalties payable by LICENSEE to THIRD PARTIES on
the manufacture, use and/or sale of VACCINE for
adjuvants and/or other technology contained in VACCINE
to the extent they are not otherwise deducted pursuant
to the provisions of Section 4 hereof or under
Paragraph 1.09 (vi) above.
Sales between or among LICENSEE and its AFFILIATES or
sublicensees shall be excluded from the computation of NET
SALES except where such AFFILIATES or sublicensees are end
users, but NET SALES shall include the subsequent final sales
to THIRD PARTIES by such AFFILIATES or sublicensees.
4.
If VACCINE is sold as a COMBINATION, NET SALES for purposes of
determining royalties on COMBINATION shall be calculated by
multiplying NET SALES by the fraction A/B, where A is the
invoice price of a monovalent form of VACCINE sold separately
and B is the invoice price of COMBINATION.
If the invoice price of a monovalent form of VACCINE is not
available and the parties are unable to agree on an
alternative arrangement, then royalty on COMBINATION shall be
determined by multiplying NET SALES by a fraction X/Y wherein
X is one (1) and Y is the total number of active antigens
included in COMBINATION with all the Rotavirus antigens being
counted as only one (1) antigen.
1.10 "PATENTS" shall mean all patents and patent applications which
are or become owned and/or controlled, in whole or in part, by
LICENSOR or to which LICENSOR otherwise has, now or in the
future, the right to grant licenses, which generically or
specifically claim VACCINE, a process for manufacturing
VACCINE and intermediates used in such process, or a use of
VACCINE. Included within the definition of PATENTS are any
continuations, continuations-in-part, divisions, patents of
addition, reissues, renewals or extensions (other than SPC)
thereof. Also included within the definition of PATENTS are
any patents and patent applications which generically or
specifically claim any improvements of VACCINE or
intermediates or manufacturing processes required or useful
for production of VACCINE which are developed by LICENSOR
and/or under which LICENSOR otherwise has the right to grant
licenses or sublicenses, now or in the future, during the term
of this Agreement. For the avoidance of doubt PATENTS do not
include patents or patent applications which claim adjuvants,
delivery systems, or other delivery vehicles or vaccines which
include solely antigens other than Rotavirus antigens. The
current list of patent applications and patents encompassed
within PATENTS is set forth in Appendix A attached hereto.
1.11 "SPC" shall mean all Supplementary Protection Certificates for
medicinal products and their equivalents provided under the
Council Regulation (EEC) No. 1768/92 of June 18, 1992 which
are directed to a VACCINE.
1.12 "VACCINE" shall mean any and all live attenuated Rotavirus
vaccines or components thereof licensed hereunder which
contain the Rotavirus 89.12 strain and/or a strain derived
from the Rotavirus 89.12 strain, developed and/or owned by
LICENSOR and/or to which LICENSOR has otherwise, now or in the
5.
future, the right to grant license and/or any and all live
attenuated Rotavirus vaccines or components thereof licensed
hereunder which are developed and/or owned by LICENSOR and/or
to which LICENSOR has otherwise, now or in the future, the
right to grant license.
1.13 "VALID CLAIM" shall mean a claim of a granted PATENT which has
not lapsed or been abandoned and which has not been declared
invalid or unenforceable by a court of competent jurisdiction
or administrative agency from which no appeal is or can be
taken.
1.13 "TERRITORY" shall mean all the countries and territories of
the world.
1.14 "THIRD PARTY(IES)" shall mean any person or party other than a
party to this Agreement or an AFFILIATE.
"Interpretative Rules". For purposes of this Agreement, except as
otherwise expressly provided herein or unless the context otherwise
requires: (a) defined terms include the plural as well as the singular
and the use of any gender shall be deemed to include the other gender;
(b) references to "Articles", "Sections", "Paragraphs" and other
subdivisions and to "Appendices", "Schedules" and "Exhibits" without
reference to a document, are to designated Articles, Sections,
Paragraphs and other subdivisions of, and to Appendices, Schedules and
Exhibits to, this Agreement; (c) the use of the term "including" means
"including but not limited to"; and (d) the words "herein", "hereof",
"hereunder" and other words of similar import refer to this Agreement
as a whole and not to any particular provision.
2. GRANT
2.01 LICENSOR hereby grants to LICENSEE and its AFFILIATES an
exclusive license, with the right subject to Paragraph 2.02 to
grant sublicenses, under PATENTS, KNOW-HOW and any SPC to
make, have made, use, have used, sell, offer for sale, have
sold, keep, import and export VACCINE and COMBINATION, in the
TERRITORY, in any formulation, configuration, combination
and/or delivery system, subject to the terms and conditions of
this Agreement.
2.02 LICENSEE agrees to notify LICENSOR of any sublicense under
PATENTS and/or KNOW-HOW it shall grant to any THIRD PARTY(IES)
and, at
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LICENSOR's request, agrees to provide LICENSOR with suitably
redacted versions of the sublicense agreements LICENSEE may
enter into with said THIRD PARTY(IES).
2.03 Notwithstanding anything else to the contrary herein, LICENSEE
agrees that PATENTS and KNOW-HOW shall be used by LICENSEE
only in and for VACCINES and in accordance with this Agreement
and can only be used by LICENSEE for so long as and to the
extent this Agreement and the licences and rights granted
hereunder are not terminated pursuant to Paragraph 10.02,
10.03, 10.04 or 10.06.
2.04 To the extent that any rights and licenses granted to LICENSEE
under this Agreement are rights and licenses obtained by
LICENSOR under an agreement with a THIRD PARTY ("Third Party
Agreement"), then any such rights and licenses granted to
LICENSEE will be subject to the terms, conditions and
obligations of such Third Party Agreement. LICENSEE
specifically acknowledges that the obligations contained in
Sections 2.4 (c), 8 and 10 (attached hereto as Appendix E) of
a certain License and Clinical Trials Agreement between
LICENSOR and the James N. Gamble Institute of Medical Research
("the Gamble Agreement") will be binding on LICENSEE.
3. PAYMENTS AND ROYALTIES
3.01 LICENSEE shall make the following license fee payment to
LICENSOR, which payment shall be non-refundable to LICENSEE
for any reason: [*]
3.02 As consideration for the license under PATENTS granted to
LICENSEE under this Agreement, LICENSEE shall pay to LICENSOR
the following royalties ("Patent Royalty(ies)"):
(a) [*]
(b) [*]
(c) [*] ; and
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(d) [*]
provided that the VACCINE sold is covered by a VALID CLAIM in
the particular country where sales are made.
3.03 As consideration for the license to KNOW-HOW granted to
LICENSEE under this Agreement, LICENSEE shall pay to LICENSOR
royalties on NET SALES in those countries wherein there is no
granted PATENT or wherein a patent application is pending or
wherein there is no VALID CLAIM ("Know-How Royalty(ies)"),
provided that the making, using or selling of VACCINE actually
use KNOW-HOW which LICENSOR has identified in writing as being
secret and substantial at the time of disclosure to LICENSEE.
The rate of the Know-How Royalties payable under this
Paragraph 3.03 shall, on a country-by-country basis, be [*]
that would be payable under paragraph 3.02 hereto considering
the applicable portion of annual NET SALES. In the event
LICENSEE, in a specific country, faces competition with a
vaccine which represents [*] of NET SALES in such country, the
sale of which vaccine would infringe PATENTS if sold in
patented countries (a "Competitive Vaccine"), the rate of the
Know-How Royalties payable by LICENSEE to LICENSOR on NET
SALES in such country shall only be [*] that, considering the
applicable portion of annual NET SALES, would be payable under
Paragraph 3.02 hereof. LICENSEE acknowledges that the supply
of the Rotavirus 89.12 strain by LICENSOR to LICENSEE shall
constitute supply of KNOW-HOW which is secret, substantial and
identified as being secret and substantial and that Know-How
Royalties due under this Paragraph 3.03, subject to Paragraph
3.05, shall be payable on NET SALES of VACCINE which contains
such strain(s) or any strain derived therefrom.
3.04 LICENSEE's royalty obligations under Paragraph 3.02 shall
become effective in each country in the TERRITORY, on a
country-by-country basis, at such time as there is a VALID
CLAIM in such country covering the VACCINE sold and shall be
applicable until expiry of the last remaining PATENT in such
country. In the event that any THIRD PARTY initiates any legal
or administrative proceedings challenging the validity, scope
or enforceability of a PATENT in any country in the TERRITORY
and a THIRD PARTY sells a Competitive Vaccine in such
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Exchange Commission.
CONFIDENTIAL TREATMENT
8.
country, then the Patent Royalties on NET SALES pursuant to
Paragraph 3.02 in such country shall be suspended during
pendency of the proceedings while such Competitive Vaccine is
sold in such country and a Know-How Royalty calculated
pursuant to Paragraph 3.03 shall be due instead for the period
specified in Paragraph 3.05 with the Know-How Royalty being
[*]. If the validity, scope and enforceability of claims
in the PATENT which cover VACCINE are upheld by a court or
other legal or administrative tribunal from which no appeal is
or can be taken, then the amount of Patent Royalties which
would have been due during the period of suspension, less any
amount of paid Know-How Royalties, shall be promptly paid with
interests, the interest rate being the Interbank Bank of
America base rate. If the claims in the PATENT which cover
VACCINE are held to be invalid or otherwise unenforceable by a
court or other legal or administrative tribunal from which no
appeal is or can be taken then LICENSOR shall retain the
Know-How Royalties paid under this Paragraph 3.04 and no
further royalties under Paragraph 3.02 shall be owed in such
country provided that in the event LICENSEE has paid to
LICENSOR a Know-How royalty pursuant to this Paragraph 3.04
after the expiration of the period specified in Paragraph
3.05, the amount of such Know-How Royalties paid by LICENSEE
shall be promptly reimbursed by LICENSOR to LICENSEE with
interests.
3.05 LICENSEE's Know-How Royalty obligations under Paragraph 3.03
shall be effective, on a country-by-country basis, for a
period of ten (10) years from LICENSEE's first commercial sale
of VACCINE as part of a nationwide introduction of VACCINE in
such country of the TERRITORY.
3.06 In the event the only remaining patent protection afforded to
a PRODUCT in any country of the TERRITORY where it is sold is
a SPC, LICENSEE shall pay to LICENSOR a royalty on NET SALES
in that country at the applicable Patent Royalty rate pursuant
to Paragraph 3.02 if LICENSEE does not face competition from a
Competitive Vaccine with respect to VACCINE in that country
and at the applicable Know-How royalty rate pursuant to
Paragraph 3.03 if LICENSEE does face competition from a
Competitive Vaccine with respect to VACCINE in that country.
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Exchange Commission.
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9.
3.07 In the event that LICENSOR secures rights to any live
attenuated Rotavirus strain(s) other than the Rotavirus 89.12
strain which LICENSEE considers is(are) useful or necessary
for VACCINE, LICENSOR shall, at LICENSEE's sole option,
transfer such other live attenuated Rotavirus strain(s) to
LICENSEE with unrestricted rights to use such strain(s)
whereupon LICENSEE shall contribute to [*] of the procurement
costs of LICENSOR.
In the event that LICENSOR is offered a license to
improvements on Inventions (as defined in the Gamble
Agreement) under paragraph 2.5 of the Gamble Agreement,
LICENSOR shall notify LICENSEE forthwith and provide all
information with respect thereto received by LICENSOR. If
requested in writing by LICENSEE, LICENSOR shall exercise the
option provided that LICENSEE pays the costs and expenses
thereof. Any licensing rights obtained by LICENSOR as a result
of the exercise of the option upon LICENSEE's request shall
automatically be included in the license granted to LICENSEE
hereunder. Any costs and expenses paid by LICENSEE in relation
to the exercise of the option for licensing rights to
improvements on Inventions shall be fully creditable against
any royalties paid hereunder.
4. COMPULSORY LICENSES, BLOCKING PATENTS AND OTHER ROTAVIRUS ANTIGENS
4.01 In the event that a governmental agency in any country or
territory grants or compels LICENSOR or LICENSEE to grant a
license under PATENTS and/or KNOW-HOW to any THIRD PARTY for
any vaccine(s) that compete(s) with VACCINE sold by LICENSEE,
LICENSEE shall have the benefit in such country or territory
of the terms granted to such THIRD PARTY to the extent that
such terms as a whole are more favourable to the THIRD PARTY
than those granted to LICENSEE under this Agreement.
4.02 The parties recognize that BLOCKING PATENTS may exist. If at
any time during the term of this Agreement LICENSEE, in its
sole discretion, deems it necessary to seek a license under
any BLOCKING PATENT(S) from any THIRD PARTY in order to
practice the rights and licenses granted by LICENSOR to
LICENSEE hereunder in any particular country(ies), [*]
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Exchange Commission.
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10.
4.03 In the event that Rotavirus antigens (other than Rotavirus
antigens produced from strain 89.12 or derivatives thereof)
are required to provide and/or to increase protection against
any specific Rotavirus serotype, the royalties payable to
LICENSOR pursuant to Paragraph 3.02 or pursuant to Paragraph
3.03, as appropriate, shall be reduced by [*].
4.04 In no event shall the combined royalty reductions and
deductions pursuant to Paragraphs 4.02 and 4.03 cause the
level of royalties otherwise due to LICENSOR pursuant to
Paragraph 3.02 or pursuant to Paragraph 3.03, as appropriate,
to be reduced by [*] with respect to any VACCINE in any
country for any calendar quarter.
5. DEVELOPMENT AND MILESTONES
5.01 Subject to the provisions of Paragraph 5.02 below, LICENSEE
will, in accordance with LICENSEE's reasonable business and
scientific judgement, exercise its reasonable efforts and
diligence in developing VACCINE and in undertaking
investigations and actions required to obtain appropriate
governmental approvals to market VACCINE in at least the MAJOR
MARKETS and in commercialising VACCINE in such MAJOR MARKETS.
All such activity shall be undertaken at LICENSEE's expense.
At LICENSEE's request and expense, LICENSOR shall supply
LICENSEE with reasonable technical assistance in undertaking
such investigations and actions.
5.02 The parties shall institute a development program with the
objective of advancing VACCINE to commercial launch. The
responsibilities of the parties shall be as follows:
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Exchange Commission.
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(a) FIRST PHASE
LICENSOR has initiated a Phase II clinical trial to
demonstrate proof of concept of VACCINE and shall
complete such trial at LICENSOR's cost and expense.
The parties shall agree on acceptable end points
concerning immunogenicity, safety and efficacy for
proof of concept which end points shall be attached
hereto as Appendix C and the meeting of such end
points shall establish proof of concept.
In parallel with said Phase II trial, LICENSEE
shall at its expense perform feasibility studies to
produce VACCINE with a commercial cell line. The
feasibility studies will have the purpose of (i)
demonstrating that a commercially viable yield is
obtainable from the chosen cell line(s), (as
defined in Appendix D attached hereto) and (ii)
subject to prior successful completion of (i),
optimizing the manufacturing process, and, if
necessary and feasible, producing GMP commercial
products for use in a Phase III clinical study and
in Phase II/III bridging studies.
(b) MILESTONE - PHASE II/MANUFACTURING
Contingent upon (i) LICENSOR establishing proof of
concept under Paragraph 5.02 (a) and (ii) LICENSEE
demonstrating that VACCINE can be produced in
commercially viable yields under Paragraph 5.02 (a)
LICENSEE shall pay LICENSOR a development milestone
fee of [*] unless LICENSEE notifies LICENSOR in
writing that LICENSEE has decided not to pursue the
development of VACCINE within sixty (60) days after
successful completion of first phase by both
parties.
If however LICENSOR is not able to demonstrate
satisfactory proof of concept at the end of Phase
II trial and/or LICENSEE cannot demonstrate in
accordance with Paragraph 5.02 (a) within six (6)
months after proof of concept in the Phase II trial
that a commercially viable yield can be obtained,
then the parties shall negotiate in good faith to
determine whether further joint development is
warranted and, if no agreement can be reached, this
Agreement may be terminated at the option of
LICENSEE if LICENSOR has
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12.
been unable to demonstrate satisfactory proof of
concept at the end of Phase II trial and at the
option of LICENSOR if LICENSEE has been unable to
demonstrate that a commercially viable yield can be
obtained.
(c) MILESTONE - PHASE III/TRIAL INITIATION
Contingent upon satisfactory completion of the
Phase II clinical and manufacturing milestone in
accordance with Paragraph 5.02 (b), LICENSEE shall
prepare a clinical development plan and discuss the
suitability of such plan with the FDA and shall
exert reasonable efforts to obtain FDA's approval
of such plan under an IND within a reasonable
timeframe to be agreed upon in good faith between
the parties.
If LICENSEE, after discussion with the FDA, is
satisfied with the economics of such plan and
decides to advance to pivotal Phase III, it shall
at its expense conduct a pivotal Phase III clinical
trial. LICENSOR shall be consulted in the design of
such trial and shall participate in the running of
the trial but LICENSEE shall exercise the ultimate
control and management of the trial.
Upon initiation of the Phase III clinical study
under an IND the design of which has been discussed
with and approved by the FDA, LICENSEE shall pay
LICENSOR a second milestone fee of [*].
If LICENSEE, after discussion with the FDA, is not
satisfied with the economics of such plan and
decides to discontinue the VACCINE development, the
second milestone fee shall not be due.
However, should LICENSEE decide to conduct the
Phase III clinical study with, and pursue the
development of, VACCINE in a MAJOR MARKET of Europe
rather than in the USA, the second milestone fee
shall be reduced to [*].
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Exchange Commission.
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(d) MILESTONE - PHASE III/COMPLETION
Provided that the pivotal Phase III study on
completion provides satisfactory results that in
LICENSEE's opinion can be used for submission of a
registration file in a MAJOR MARKET, then LICENSEE
shall pay LICENSOR a third milestone fee of [*]. In
the event that the results of the Phase III study
are not acceptable for registration purpose, such
third milestone fee shall be payable only when a
regulatory submission is first made in a MAJOR
MARKET.[*]
(e) REGISTRATION MILESTONE
LICENSEE shall pay a milestone fee of [*]
5.03 LICENSEE shall report to LICENSOR on the status and progress
of LICENSEE's efforts to develop and commercialise VACCINE at
such times and in such manner as LICENSOR may reasonably
request.
5.04 LICENSOR shall provide to LICENSEE, at LICENSEE's request and
expense, technical assistance within its area of expertise
concerning development, production and commercialisation of
VACCINE. Provision of such technical assistance shall include,
but not be limited to, visits by LICENSOR personnel to
LICENSEE and visits by LICENSEE personnel to LICENSOR at times
and for periods of time upon which the parties will agree.
5.05 In the event that LICENSEE's development of VACCINE is
terminated at any time under the provisions of this Section 5
other than for failure by LICENSOR to establish satisfactory
proof of concept, LICENSEE shall, to the extent that it is
allowed and free to do so, grant LICENSOR a license under its
manufacturing
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14.
technology specific for VACCINES in exchange for a reasonable
compensation to be discussed and agreed upon in good faith by
the parties.
In the event LICENSEE, at its sole option, elects not to
market VACCINE itself or through its AFFILIATES in any MAJOR
MARKET(S), LICENSEE shall give LICENSOR a first option for the
grant of marketing sub-licensing rights in any such MAJOR
MARKET upon terms and conditions to be negotiated and agreed
upon in good faith by the parties.
In the event LICENSEE, at its sole option, elects not to
market VACCINE itself or through its AFFILIATES and/or
sublicensees in any MAJOR MARKET(S), the rights and licenses
granted to LICENSEE under this Agreement shall be terminated
with respect to any such MAJOR MARKET(S).
6. EXCHANGE OF INFORMATION AND CONFIDENTIALITY
6.01 During the term of this Agreement, LICENSOR shall promptly
disclose to LICENSEE and/or supply LICENSEE with all
KNOW-HOW. LICENSOR shall not be authorized to make any
publication with respect to the KNOW-HOW nor disclose it to
any THIRD PARTY provided that, LICENSOR shall, upon LICENSEE's
prior consent in writing which consent shall not be
unreasonably withheld, be authorized to publish the data from
the Phase II clinical trial referred to in Paragraph 5.02
hereof and prior studies and, without consent, be authorized
to disclose KNOW-HOW to its licensor as per the Gamble
Agreement.
6.02 During the term of this Agreement, the parties shall promptly
inform each other of any information that a party obtains or
develops regarding the utility and safety of VACCINE and shall
promptly report to the other party any confirmed information
of serious or unexpected reactions or side effects related to
the utilisation or medical administration of VACCINE.
6.03 During the term of this Agreement and for seven (7) years
thereafter, irrespective of any termination earlier than the
expiration of the term of this Agreement, LICENSOR and
LICENSEE shall not reveal or disclose to THIRD PARTIES any
confidential information received from the other party without
first obtaining the written consent of the disclosing party,
except as may be required for purposes of investigating,
developing, manufacturing or marketing VACCINE
15.
or for securing essential or desirable authorisations,
privileges or rights from governmental agencies, or is
required to be disclosed to a governmental agency, or is
necessary to file or prosecute patent applications concerning
VACCINE or to carry out any litigation concerning VACCINE
provided that in each case the disclosing party exerts best
efforts to maintain the confidentiality thereof under such
circumstances and notifies the owner of the confidential
information prior to any such disclosure. This confidentiality
obligation shall not apply to such information which is or
becomes a matter of public knowledge, or is already in the
possession of the receiving party, or is disclosed to the
receiving party by a THIRD PARTY having the right to do so, or
is subsequently and independently developed by employees of
the receiving party or AFFILIATES thereof who had no knowledge
of the confidential information disclosed. The parties shall
take reasonable measures to assure that no unauthorised use or
disclosure is made by others to whom access to such
information is granted.
6.04 Nothing herein shall be construed as preventing a party hereto
from disclosing any information received from the other party
to an AFFILIATE, sublicensee, distributor or to a THIRD PARTY
as may be required for purposes of investigating, developing,
manufacturing or marketing VACCINE, provided such AFFILIATE,
sublicensee, distributor or THIRD PARTY has undertaken a
similar obligation of confidentiality with respect to the
disclosed confidential information.
6.05 All confidential information disclosed by one party to the
other shall remain the intellectual property of the disclosing
party. In the event that a court or other legal or
administrative tribunal, directly or through an appointed
master, trustee or receiver, assumes partial or complete
control over the assets of a party to this Agreement based on
the insolvency or bankruptcy of such party, the bankrupt or
insolvent party shall promptly notify the court or other
tribunal (i) that confidential information received from the
other party under this Agreement remains the property of the
other party and (ii) of the confidentiality obligations under
this Agreement. In addition, the bankrupt or insolvent party
shall, to the extent permitted by law, take all steps
necessary or desirable to maintain the confidentiality of the
other party's confidential information and to insure that the
court, other tribunal or appointee maintains such information
in confidence in accordance with the terms of this Agreement.
6.06 No public announcement or other disclosure to THIRD PARTIES
concerning the existence of or the terms of or the subject
matter covered by this Agreement
16.
shall be made, either directly or indirectly, by any party to
this Agreement, without first obtaining the approval of the
other party and agreement upon the nature and text of such
announcement or disclosure. The party desiring to make any
such public announcement or other disclosure shall inform the
other party of the proposed announcement or disclosure in
reasonable sufficient time prior to public release, and shall
provide the other party with a written copy thereof, in order
to allow such other party to comment upon such announcement or
disclosure. If such public announcement or other disclosure is
required under securities laws or rules or pursuant to a
public or private financing the concerned party needs not
obtain the consent of the other party but shall provide the
other party with a five (5) working days notice allowing the
other party to review and comment upon such proposed
disclosure and/or announcement and such other party shall
cooperate fully with the concerned party with respect to all
disclosures regarding this Agreement to the United States
Securities Exchange Commission and any other governmental or
regulatory agencies, including requests for confidential
treatment of proprietary information of either party included
in any such disclosure.
6.07 Neither LICENSEE nor LICENSOR shall submit for written or oral
publication any manuscript, abstract or the like which
includes data or other information generated and provided by
the other party without first obtaining the prior written
consent of the other party, which consent shall not be
unreasonably withheld. The contribution of each party shall be
noted in all publications or presentations by acknowledgement
or coauthorship, whichever is appropriate.
7. PATENT PROSECUTION AND LITIGATION
7.01 LICENSOR, or any entity having granted or granting rights to
LICENSOR, shall be responsible for the filing, prosecution and
maintenance of PATENTS which, subject to Paragraph 7.02, shall
be at the cost and expense of LICENSOR (or the entity having
granted or granting rights to LICENSOR). LICENSOR shall
disclose to LICENSEE the complete texts of all patent
applications within PATENTS as well as all information
received concerning the institution or possible institution of
any interference, opposition, re-examination, reissue,
revocation, nullification or any official proceedings
involving a PATENT anywhere in the TERRITORY. LICENSEE shall
have the right to review all such pending applications and
other proceedings and to make comments and/or recommendations
to LICENSOR concerning them and their conduct and
17.
LICENSOR shall consider, in good faith, all such LICENSEE's
comments and/or recommendations. LICENSOR agrees to keep
LICENSEE promptly and fully informed of the course of patent
prosecution or other proceedings including by providing
LICENSEE with copies of substantive communications, search
reports and THIRD PARTY observations submitted to or received
from patent offices throughout the TERRITORY. LICENSOR shall
provide such patent consultation to LICENSEE at no cost to
LICENSEE. LICENSEE shall hold all information disclosed to it
under this section as confidential subject to the provisions
of Paragraphs 6.03 and 6.04.
7.02 LICENSOR shall notify LICENSEE in sufficiently reasonable time
in advance of any PATENT or subject matter or claim contained
in PATENT which LICENSOR intends to abandon or otherwise cause
or allow to be forfeited and LICENSEE shall have the right to
assume responsibility for filing, prosecution and maintenance
of any such PATENT or subject matter or claim contained in
PATENT at LICENSEE's expense provided LICENSOR has the right
to permit LICENSEE to assume such responsibility.
7.03 In the event of the institution of any suit by a THIRD PARTY
against LICENSOR, LICENSEE or its AFFILIATES or sublicensees
for patent infringement involving the manufacture, use, sale,
distribution or marketing of VACCINE anywhere in the
TERRITORY, the party sued shall promptly notify the other
party in writing. Subject to Section 21 below, LICENSEE shall
have the right but not the obligation to defend such suit at
its own expense. LICENSOR and LICENSEE shall reasonably assist
one another and cooperate in any such litigation at the
other's request without expense to the requesting party.
7.04 In the event that LICENSOR or LICENSEE becomes aware of actual
or threatened infringement of a PATENT anywhere in the
TERRITORY, that party shall promptly notify the other party in
writing. LICENSEE shall have the first right but not the
obligation to bring, at its own expense, an infringement
action against any THIRD PARTY and to use LICENSOR's name in
connection therewith. If LICENSEE does not commence a
particular infringement action within ninety (90) days,
LICENSOR, after notifying LICENSEE in writing, shall be
entitled, but not obligated, to bring such infringement action
at its own expense. The party conducting such action shall
have full control over its conduct, including settlement
thereof provided that LICENSEE shall not take any steps,
including settlement, which would have an adverse effect on
PATENTS unless LICENSOR's consent is obtained. In any event,
LICENSOR and LICENSEE
18.
shall reasonably assist one another and cooperate in any such
litigation at the other's request without expense to the
requesting party.
7.05 LICENSOR and LICENSEE shall recover their respective actual
out-of-pocket expenses, or equitable proportions thereof,
associated with any litigation or settlement thereof, from any
recovery made by any party. Any excess amount shall before the
party which has conducted the litigation or settlement
thereof.
7.06 The parties shall keep one another informed of the status of
and of their respective activities regarding any litigation or
settlement thereof concerning VACCINE.
7.07 LICENSOR shall authorise LICENSEE to act as LICENSOR's agent
for the purpose of making any application for any extensions
of the term of PATENTS, including SPC, and shall provide
reasonable assistance therefor to LICENSEE, at LICENSEE's
expense. (In the United States of America as permitted under
Title 35 of the United States Code).
7.08 LICENSOR, on behalf of itself, its officers, agents and
successors hereby waives any and all actions and causes of
action, claims and demands whatsoever in law or equity of any
kind against LICENSEE'S and its AFFILIATES' exercize of
LICENSEE's rights under Paragraphs 7.02 and 7.07, and, subject
to LICENSEE's obligations under Paragraph 7.04, against
LICENSEE's and its AFFILIATES' exercize of LICENSEE's rights
under Paragraph 7.04.
8. TRADEMARKS
8.01 LICENSEE, at its expense, shall be responsible for the
selection, registration and maintenance of all trademarks
which it employs in connection with VACCINE and COMBINATION
and shall own and/or control such trademarks. Nothing in this
Agreement shall be construed as a grant of rights, by license
or otherwise, to LICENSOR to use such trademarks for any
purpose.
19.
9. STATEMENTS AND REMITTANCES
9.01 LICENSEE shall keep and require its AFFILIATES and
sublicensees to keep complete and accurate records of all
sales of VACCINE and COMBINATION under the licenses granted
herein. LICENSOR shall have the right, at LICENSOR's expense,
through a certified public accountant or like person
reasonably acceptable to LICENSEE, to examine such records
during regular business hours during the life of this
Agreement and for six (6) months after its termination;
provided, however, that such examination shall not take place
more often than once a year and shall not cover such records
for more than the preceding two (2) years and provided further
that such accountant shall report to LICENSOR only as to the
accuracy of the royalty statements and payments. In the event
that such inspection shall indicate in any calendar year that
the royalties which should have been paid by LICENSEE are at
least five percent (5%) greater than those which were
actually paid by LICENSEE, then LICENSEE shall pay the cost of
such inspection in addition to the underpaid royalties.
9.02 Within sixty (60) days after the close of each calendar
quarter, LICENSEE shall deliver to LICENSOR a true accounting
of all VACCINES and COMBINATION sold by LICENSEE, its
AFFILIATES and its sublicensees during such quarter, and shall
at the same time pay all royalties due. Such accounting shall
show sales, NET SALES and deductions against royalties on NET
SALES on a country-by-country and product-by-product basis.
9.03 Any tax paid or required to be withheld by LICENSEE on behalf
of LICENSOR on account of royalties payable to LICENSOR under
this Agreement shall be deducted from the amount of royalties
otherwise due. LICENSEE shall secure and send to LICENSOR
proof of any such taxes withheld and paid by LICENSEE or its
sublicensees for the benefit of LICENSOR.
9.04 All royalties due under this Agreement shall be payable in
United States Dollars. Monetary conversions from the currency
of a foreign country in which VACCINE is sold into US currency
shall be made at the exchange rate in force on the last
business day of the period for which the royalties are being
paid as published by Banque Generale de Belgique, Brussels,
Belgium, or on another basis mutually agreed to by both
parties in writing.
20.
10. TERM AND TERMINATION
10.01 Unless otherwise terminated, this Agreement shall expire upon
the expiration, lapse or invalidation of the last remaining
PATENT in the TERRITORY. Expiration of this Agreement under
this provision shall not preclude LICENSEE from continuing to
market VACCINE and to use KNOW-HOW without any further royalty
or other payments to LICENSOR.
10.02 If either party fails or neglects to perform covenants or
provisions of this Agreement and if the party in default has
not corrected such default within sixty (60) days (the period
shall be thirty (30) days for a payment default) after
receiving written notice from the other party with respect to
such default, such other party shall have the right to
terminate this Agreement by giving written notice to the party
in default provided the notice of termination is given within
six (6) months of the default and prior to correction of the
default. If the default other than a payment default is not
curable in sixty (60) days and the defaulting party in good
faith notifies the other party in writing prior to the sixty
(60) days that it is initiating cure of the default and
initiates cure of such default within the sixty (60) days and
in good faith continues to attempt to cure the default, and in
fact cures the default within one hundred and twenty (120)
days, then this Agreement shall not be terminable hereunder.
10.03 LICENSEE may terminate this Agreement in its entirety or with
respect to any country by giving LICENSOR at least three (3)
months prior written notice thereof.
10.04 Either party may terminate this Agreement if, at any time, the
other party shall file in any court or agency pursuant to any
statute or regulation of (the United States or of) any
(individual) state or (foreign) country, a petition in
bankruptcy or insolvency or for reorganisation or for an
arrangement or for the appointment of a receiver or trustee of
the party or of its assets, or if the other party proposes a
written agreement of composition or extension of its debts, or
if the other party shall be served with an involuntary
petition against it, filed in any insolvency proceeding, and
such petition shall not be dismissed with sixty (60) days
after the filing thereof, or if the other party shall propose
or be a party to any dissolution or liquidation, or if the
other party shall make an assignment for the benefit of
creditors.
21.
10.05 Notwithstanding the bankruptcy of LICENSOR, or the impairment
of performance by LICENSOR of its obligations under this
Agreement as a result of bankruptcy or insolvency of LICENSOR,
LICENSEE, if it has not then been notified for breach by
LICENSOR, shall be entitled to retain the licenses granted
herein, subject to LICENSOR's right to terminate this
Agreement for reasons other than bankruptcy or insolvency as
expressly provided in this Agreement.
10.06 LICENSEE shall be entitled to terminate this Agreement by
written notice to LICENSOR in the event of change of control
of LICENSOR, provided such notice is given within thirty (30)
days after LICENSOR has notified LICENSEE of such change of
control or after the date which LICENSOR can demonstrate is
the date on which LICENSEE has been otherwise informed of such
change of control.
11. RIGHTS AND DUTIES UPON TERMINATION
11.01 Upon termination of this Agreement, LICENSOR shall have the
right to retain any sums already paid by LICENSEE hereunder,
and LICENSEE shall pay all sums accrued hereunder which are
then due.
11.02 Upon termination of this Agreement in its entirety or with
respect to any country under Paragraph 10.02, 10.03 or 10.04,
LICENSEE shall notify LICENSOR of the amount of VACCINE
LICENSEE and its AFFILIATES, sublicensees and distributors
then have on hand, the sale of which would, but for the
termination, be subject to royalty, and LICENSEE and its
AFFILIATES, sublicensees and distributors shall thereupon be
permitted to sell that amount of VACCINE provided that
LICENSEE shall pay the royalty thereon at the time herein
provided for.
11.03 Termination of this Agreement shall terminate all outstanding
obligations and liabilities between the parties arising from
this Agreement except those described in Paragraphs 2.03,
6.03, 6.04, 6.05, 6.06, 6.07, 7.03, 7.06, 7.08, 8.01, 9.01,
9.02, 9.03, 9.04, 9.05, 11.01, 11.02, 11.03, 14.01, 15.01,
18.01, 20.01 and 21.01.
11.04 Upon termination of this Agreement by LICENSOR pursuant to
Paragraph 10.02 for breach of LICENSEE, LICENSEE agrees not to
use KNOW-HOW and/or
22.
PATENTS for the research, development, making, using or
selling of any product or process, including, but not limited
to, VACCINES.
12. WARRANTIES AND REPRESENTATIONS
12.01 LICENSOR warrants that it has the right to grant the rights
and licences under PATENTS and KNOW-HOW as provided throughout
this Agreement including, but not limited to, the Rotavirus
89.12 strain and that it has the right to enter into this
Agreement.
12.02 Nothing in this Agreement shall be construed as a warranty
that PATENTS are valid or enforceable or that their exercise
does not infringe any patent rights of THIRD PARTIES. Without
having made an investigation or search, LICENSOR hereby
warrants and represents that it has no present knowledge from
which it can be inferred that PATENTS are invalid or that
their exercise would infringe patent rights of THIRD PARTIES
or that the Rotavirus 89.12 strain or the use thereof in
VACCINE infringes any patent rights of THIRD PARTIES. Subject
to other provisions contained herein, a holding of invalidity
or unenforceability of any PATENT, from which no further
appeal is or can be taken, shall not affect any obligation
already accrued hereunder, but shall only eliminate royalties
otherwise due under such PATENT from the date such holding
becomes final.
12.03 LICENSOR acknowledges that, in entering into this Agreement,
LICENSEE has relied upon technical and clinical information
and KNOW-HOW disclosed and/or supplied by or on behalf of
LICENSOR and that LICENSEE has relied upon LICENSOR's
obligation to disclose and/or supply further information
pursuant to Paragraph(s) 6.01 and/or 6.02 hereof. LICENSOR
warrants and represents that LICENSOR has no knowledge that
the technical and/or clinical information and/or KNOW-HOW
disclosed and/or supplied to LICENSEE prior to the date of
this Agreement is inaccurate in any material respect. LICENSOR
warrants and represents that it will use its reasonable
efforts to review the technical and/or clinical information
and/or KNOW-HOW to be disclosed and/or supplied to LICENSEE
under Paragraph(s) 6.01 and/or 6.02 hereof after the date of
this Agreement for any inaccuracies therein and that, to the
extent LICENSOR has any knowledge of any material inaccuracies
in such technical and/or clinical information and/or KNOW-HOW,
it shall inform LICENSEE of such inaccuracies. LICENSOR and
LICENSEE warrant and represent to each other that they have
not, up to the date of this Agreement, omitted to disclose
and/or supply to each
23.
other any information known to them concerning VACCINE or the
transactions contemplated by this Agreement which would, to
the best of their knowledge, be material to the other's
decision to enter into this Agreement and to undertake the
commitments and obligations set forth herein.
12.04 LICENSOR warrants and represents that it has no present
knowledge of the existence of any pre-clinical or clinical
data or information concerning VACCINE which suggests that
there may exist toxicity, safety and/or efficacy concerns
which may materially impair the utility and/or safety of
VACCINE.
13. FORCE MAJEURE
13.01 If the performance of any part of this Agreement by either
party, or of any obligation under this Agreement other than a
payment provision, is prevented, restricted, interfered with
or delayed by reason of any cause beyond the reasonable
control of the party liable to perform, unless conclusive
evidence to the contrary is provided, the party so affected
shall, upon giving written notice to the other party, be
excused from such performance to the extent of such
prevention, restriction, interference or delay, provided that
the affected party shall use its reasonable best efforts to
avoid or remove such causes of non-performance and shall
continue performance with the utmost dispatch whenever such
causes are removed. When such circumstances arise, the parties
shall discuss what, if any, modification of the terms of this
Agreement may be required in order to arrive at an equitable
solution. In the event agreement is not reached or the force
majeure event cannot be cured within six (6) months, the other
party shall have the right to terminate this Agreement by
serving a written notice to the party affected by the force
majeure event.
14. GOVERNING LAW
14.01 This Agreement shall be deemed to have been made in the United
States of America and its form, execution, validity,
construction and effect shall be determined in accordance with
the laws of the Commonwealth of Massachusetts, USA, without
regard to its choice of law principles.
24.
15. RESOLUTION OF DISPUTES
15.01 Prior to initiating legal action, the parties agree to attempt
to settle any dispute by discussions between the parties,
provided, however that this Paragraph 15.01 shall not prevent
either party from seeking injunctive relief where necessary.
If the parties have not resolved the dispute amicably, legal
action may be introduced.
16. SEPARABILITY
16.01 In the event any portion of this Agreement shall be held
illegal, void or ineffective, the remaining portions hereof
shall remain in full force and effect.
16.02 If any of the terms or provisions of this Agreement are in
conflict with any applicable statute or rule of law, then such
terms or provisions shall be deemed inoperative to the extent
that they may conflict therewith and shall be deemed to be
modified to conform with such statute or rule of law.
16.03 In the event that the terms and conditions of this Agreement
are materially altered as a result of Paragraphs 16.01 or
16.02, the parties will renegotiate the terms and conditions
of this Agreement to resolve any inequities.
17. ENTIRE AGREEMENT
17.01 This Agreement, entered into as of the date first written
above, constitutes the entire agreement between the parties
relating to the subject matter hereof and supersedes all
previous writings and understandings. No terms or provisions
of this Agreement shall be varied or modified by any prior or
subsequent statement, conduct or act of either of the parties,
except that the parties may amend this Agreement by written
instruments specifically referring to and executed in the same
manner as this Agreement.
25.
18. NO WAIVER
18.01 The failure of either party at any time to exercise any of
their respective rights under this Agreement shall not be
deemed a waiver thereof, nor shall such failure in any way
prevent either party, as the case may be, from subsequently
asserting or exercising such rights.
19. NOTICES
19.01 Any notice required or permitted under this Agreement shall be
sent by certified mail, return receipt requested, postage
pre-paid to the following addresses of the parties:
if to LICENSOR:
Virus Research Institute, Inc.,
61 Moulton Street
Cambridge, MA 02138,
USA
Attention: President
cc: Elliot M. Olstein, Esq.
Carella, Byrne, Bain, Gilfillan, Cecchi,
Stewart & Olstein
6 Becker Farm Road
Roseland, New Jersey 07068
USA
if to LICENSEE:
SmithKline Beecham P.L.C.
New Horizons Court
Brentford
Middlesex TW8 9EP
United Kingdom
with a copy to :
SmithKline Beecham Biologicals Manufacturing
S.A.
rue de l'Institut 89
26.
1330 Rixensart, Belgium
Attention : Senior Vice President,
General Manager
19.02 Any notice required or permitted to be given concerning this
Agreement shall be effective upon receipt by the party to whom
it is addressed.
20. ASSIGNMENT
20.01 Without prejudice to Paragraph 10.06, this Agreement and the
licenses herein granted shall be binding upon and inure to the
benefit of the successors in interest of the respective
parties. Neither this Agreement nor any interest hereunder
shall be assignable by either party without the written
consent of the other provided, however, that LICENSEE may,
without the consent of LICENSOR, assign this Agreement to any
AFFILIATE or to any corporation with which it may merge or
consolidate or to which it may sell all or substantially all
of its assets, and that LICENSOR may without obtaining the
consent of LICENSEE assign this Agreement to any corporation
with which it may merge or consolidate or to which it may sell
all or substantially all of its assets.
20.02 In the event of a permitted assignment hereunder the assignee
must accept in writing the obligations of this
Agreement, whereupon the assignor shall be relieved of its
obligations under this Agreement.
21. INDEMNIFICATION
21.01(a) LICENSEE agrees to defend, indemnify and hold harmless
LICENSOR, its AFFILIATES and any of their licensors that have
granted a license under which LICENSEE has received a license
under this Agreement as well as each of their respective
directors, officers, employees, shareholders, and agents
(hereinafter individually and collectively referred to as
"Indemnitee") against any and all actions, claims
(specifically including, but not limited to, any damages based
on product liability claims), suits, losses, demands,
judgments, and other liabilities (including attorneys' fees
until LICENSEE assumes the defense as described below)
asserted by THIRD PARTIES, government and non-government,
resulting from or arising out of the manufacture, use or sale
of VACCINES by LICENSEE, its AFFILIATES or sublicensees
provided however that LICENSEE's indemnification to an
27.
Indemnitee hereunder shall not apply to any liability, damage,
loss or expense to the extent that it is directly or
indirectly attributable to the gross negligence or intentional
misconduct of such Indemnitee. If any such claims or actions
are made, Indemnitee shall be defended at LICENSEE's sole
expense by counsel selected by LICENSEE and reasonably
acceptable to LICENSOR; provided that LICENSOR may, at its own
non-refundable expense, also be represented by counsel of its
own choosing.
(b) Any such Indemnitee shall notify LICENSEE promptly of any
claim or threatened claim under this Section 21, shall fully
cooperate with all reasonable requests of LICENSEE with
respect thereto, and shall give LICENSEE the right to control
the defence and settlement of any such claim provided such
Indemnitee shall be fully indemnified under this Section 21.
(c) The provision of this Section 21 shall apply whether or not an
act or claim is rightly brought or asserted.
IN WITNESS WHEREOF, the parties, through their authorised officers, have
executed this Agreement as of the date first written above.
VIRUS RESEARCH INSTITUTE Inc.
/s/ William A. Packer
-----------------------------
BY: WILLIAM A. PACKER
TITLE: PRESIDENT
SMITHKLINE BEECHAM P.L.C.
/s/ Jean Stephenne
-----------------------------
BY: JEAN STEPHENNE
TITLE: Senior Vice President, General Manager
CONFIDENTIAL TREATMENT
APPENDIX A
PATENT INFORMATION
[*]
/*/ Confidential material omitted and filed separately with the Securities and
Exchange Commission.
CONFIDENTIAL TREATMENT
APPENDIX B
VRI PROPRIETARY INFORMATION AND KNOW-HOW,
89-12 ROTAVIRUS VACCINE
8 October 1997
[*]
/*/ Confidential material omitted and filed separately with the Securities and
Exchange Commission.
CONFIDENTIAL TREATMENT
APPENDIX C
PHASE II CLINICAL ENDPOINTS
[*]
/*/ Confidential material omitted and filed separately with the Securities and
Exchange Commission.
APPENDIX D
MANUFACTURING ENDPOINT
- - - Yield a minimum of 1 dose/ml
- - - This yield should be achieved in a cell line acceptable for commercial
production and acceptable to regulatory authorities.
APPENDIX E
EXCERPTS OF LICENSE AND CLINICAL TRIALS AGREEMENT
DATED FEBRUARY 27, 1995 BETWEEN VIRUS RESEARCH INSTITUTE, INC AND JAMES N.
GAMBLE INSTITUTE OF MEDICAL RESEARCH
2.4 (a)
(b)
(c) VRI agrees to forward to GAMBLE a copy of any and all fully
executed sublicense agreements within thirty (30) days of execution thereof, and
further agrees to forward to Gamble annually a copy of such reports received by
VRI from its Sublicensee during the preceding twelve (12) month period under the
sublicenses as shall be pertinent to a royalty accounting under said sublicense
agreements. VRI may delete from copies of sublicense agreements provided to
GAMBLE hereunder commercial, research and development, manufacturing, financial
and other provisions unrelated to VRI's or the Sublicensee's obligations to
Gamble.
8. INDEMNIFICATION AND INSURANCE.
8.1 VRI shall defend, indemnify and hold harmless GAMBLE and its trustees,
officers, medical and professional staff, employees, and agents and their
respective successors, heirs and assigns against all losses, damages, expenses,
including attorney's fees and against any claims, suits, actions, demands or
judgments brought against any one or more of them, arising out of any theory of
product liability (including, but not limited to, action in the form of tort,
warranty, or strict liability) or negligence concerning any product, process or
service made, used or sold pursuant to any right or license granted under this
AGREEMENT. VRI shall have the right to control the defense settlement and/or
compromise of any such claims or actions.
8.2 VRl's obligations under Section 8.1 above shall not apply to any
liability, damage, loss or expense to the extent that it is directly
attributable to the negligence or intentional misconduct of GAMBLE or any of its
trustees, officers, medical and professional staff, employees, agents or their
respective successors, heirs or assigns.
8.3 VRI shall add, at VRl's expense, GAMBLE as an additional insured on
VRI's clinical trial insurance policy, which provides limits of liability of
$2,000,000 per incident and aggregate, effective upon the Effective Date of this
AGREEMENT, to provide insurance coverage for GAMBLE for the clinical trials.
8.4 VRI, at VRl's expense, shall maintain policies of comprehensive
general liability insurance and will obtain product liability insurance in
amounts not less than $1,000,000 per incident and $2,000,000 annual aggregate
and shall add GAMBLE as an additional insured on VRI's policy, which provides
such limits of liability. Such insurance shall provide (i) product liability
coverage, (ii) negligence, and (iii) broad form contractual liability coverage,
for VRI's indemnification under Section 8.1 of this AGREEMENT. The minimum
amounts of insurance coverage required under these provisions shall not be
construed to create a limit of VRI's liability with respect to VRI's
indemnification obligation under Section 8.1 of this AGREEMENT. VRI shall
maintain such comprehensive general liability insurance and product liability
insurance beyond the expiration or termination of this AGREEMENT and for a
reasonable period after the termination of the clinical trials, which in no
event shall be less than fifteen (15) years after the clinical trials.
8.5 This Section 8 shall survive expiration or termination of this
AGREEMENT.
10. CONFIDENTIALITY
10.1 CONFIDENTIAL INFORMATION. As used in this AGREEMENT, "Confidential
Information" means all information transmitted by a party hereto or obtained by
a party hereto in connection with the performance of the clinical trials and
other services described in Section 3 hereof or of any such other services to be
provided by the parties as described herein, subject to the exceptions specified
below. "Confidential Information" means information of any type, not generally
known, about the business, processes, services, products, suppliers, customers,
clients or plans of GAMBLE or VRI ("the parties hereto") of any client of the
parties hereto (regardless of whether the parties hereto have executed a
confidentiality agreement with such customer), which is used or useful in the
conduct of business of the parties hereto, or which confers or tends to confer a
competitive advantage over one who does not possess such information. Such
information includes, but is not limited to, information relating to trade
secrets, Technical Information, patent applications, know-how, research,
development, design, engineering, quality control or service techniques,
information about existing, new or envisioned products, processes or services
and their development, performance, scientific, engineering or technical
information, laboratory notebooks, notes, computer programs, source codes,
object codes, software manuals, sketches, drawings, reports, formulae, gels,
slides, sequences, biological materials living or otherwise, photographs,
negatives, prototypes, models, correspondence, and other documents and things,
and information relating to purchasing, sales, marketing, licensing, contracts
with third parties, and pricing, whether or not in writing and whether or not
labeled or identified as confidential or proprietary. Confidential Information
may be disclosed in writing or orally or may be obtained by observation or
inspection. All data, materials, information, and records developed by a party
hereto in the course of performing this AGREEMENT shall be considered
Confidential Information. However, Confidential Information shall not include
information that a party hereto can demonstrate: (i) is in or enters the public
domain through no fault of such party; (ii) is disclosed to a party hereto by a
third party entitled to disclose it; (iii) was known to a party hereto before
the date of this AGREEMENT; OR (iv) is required by law to be disclosed, provided
reasonable advance notice of such requirement is given to a party hereto before
such disclosure.
10.2 CONFIDENTIALITY. Without prior written consent, the parties hereto
will not disclose the other party's Confidential Information to any third party
other than employees, agents or others of the parties hereto who must
necessarily be informed thereof, but only if and to the extent that any such
person has a need for such information. A party hereto will only use
Confidential Information for the purpose of fulfilling its obligations under
this AGREEMENT. The parties hereto agree that they will take such reasonable
steps as may be necessary to prevent the disclosure or use of any such materials
by their officers, employees or agents except as provided herein, including but
not limited to obtaining and enforcing appropriate confidentiality agreements
with such persons. All obligations of confidentiality and nondisclosure set
forth in this AGREEMENT shall survive the termination or expiration of this
AGREEMENT.
10.3 The parties agree that clinical trial data generated by GAMBLE under
the terms of the AGREEMENT will not be published by VRI prior to its publication
by GAMBLE's principal investigators. To the extent not published, the results of
the clinical trials will be held in confidence by GAMBLE. Subject to the
foregoing, VRI will have the unrestricted right to use or disclose such clinical
trial data.