EXHIBIT 10.5
CONFIDENTIAL
R&D AND LICENSE AGREEMENT
This License Agreement ("Agreement") is made effective as of the seventh
(7th) day of February 1997 ("Effective Date"), between PEPTIDE THERAPEUTICS
LIMITED, having a place of business at 321 Cambridge Science Park, Xxxxxx Xxxx,
Xxxxxxxxx XX0 0XX, Xxxxxx Xxxxxxx (herein referred to as "PTL") and SMITHKLINE
XXXXXXX PLC, having a place of business at New Horizons Court, Great Xxxx Xxxx,
Xxxxxxxxx, Xxxxxxxxx XX0 0XX, Xxxxxx Xxxxxxx (herein referred to as "SB").
WITNESSETH THAT:
WHEREAS, PTL is the owner of and/or controls all right, title and interest
in certain patents, identified in Schedule A hereto, and know-how relating to
anti IgE vaccine(s); and
WHEREAS, PTL has developed and/or controls certain technologies relating to
prevention, control and/or treatment of allergic disorders in humans which may
be useful for the development of active or passive prophylactic or therapeutic
anti IgE vaccine(s) against allergies.
WHEREAS, PTL and SB have an interest to enter into a research collaboration
for the development and commercialisation of the above mentioned vaccines.
WHEREAS, SB has an interest in acquiring simultaneously a worldwide and
exclusive license under any existing and future patent, patent applications,
know how and improvements owned, controlled or developed by PTL relating to the
above mentioned technologies.
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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 "COMBINATION" shall mean a PRODUCT which contains also one or more
therapeutically and/or prophylactically active antigens and/or
allergens which are not included in TECHNOLOGY. Any COMBINATION is a
PRODUCT.
1.03 "FIELD" shall mean prevention, control and/or treatment of any and
all allergic disorders in humans, (including but not limited to Type
1 hypersensitivity (allergy) reactions) mediated by IgE immune
activity and/or other immune mechanisms, excluding SPECIFIC FIELD.
1.04 "KNOW-HOW" shall mean all present and future technical information,
materials and know-how which relate to PRODUCT which are now and/or
at anytime during the term of this Agreement developed, owned,
proprietary to and/or controlled by PTL and/or any AFFILIATES of
PTL, and which are necessary for or useful to the development,
production and commercialisation of PRODUCT. KNOW-HOW shall include,
without limitation, all chemical, pharmacological, toxicological,
clinical, assay, control and manufacturing data and any other
information relating thereto and any materials, seeds, strains,
reagents and media. KNOW-HOW shall not include PATENTS.
1.05 "NET SALES VALUE" shall mean the gross receipts from sales of
PRODUCT in the TERRITORY by SB and/or its AFFILIATES and/or its
sublicensees and/or its distributors to THIRD PARTIES less the
following deductions :
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(i) []* of the gross receipts to cover transportation charges,
including insurance; and
(ii) SB's standard costs for PRODUCT formulation, filling and
packaging, for syringes and other administration devices
combined with, or contained in, commercial packaging; and
(iii) sales and excise taxes and duties paid or allowed by a selling
party and any other governmental charges imposed upon the
production, importation, use or sale of PRODUCT, including
without limitation, contributions and payments required by any
governmental authorities as liability provisions and/or made
pursuant to injury compensation schemes and/or as PRODUCT
liability insurance premiums; and
(iv) trade, quantity and cash discounts, commissions and other
customary rebates; and
(v) allowances or credits to customers or charges back from
customers on account of rejection or return of PRODUCT subject
to royalty under this Agreement or on account of retroactive
price reductions affecting such PRODUCT; and
(vi) royalties payable and/or paid by SB to THIRD PARTIES on the
manufacture, use and/or sale of PRODUCT []* .
Sales between or among SB and its AFFILIATES or sublicensees or
distributors shall be excluded from the computation of NET SALES
VALUE except where such AFFILIATES or sublicensees are end users,
but NET SALES VALUE shall include the subsequent final sales to
THIRD PARTIES by such AFFILIATES or sublicensees or distributors.
If a PRODUCT is sold as a COMBINATION, NET SALES VALUE of
COMBINATION shall be multiplied by the fraction A/A+B where A is the
unit invoice price of a separately sold PRODUCT which contains as
specific immunogenic material only those antigen(s) and/or
allergen(s) contained in COMBINATION which are included in
TECHNOLOGY and B is the unit invoice price of a separately sold
vaccine which contains as specific immunogenic
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* This portion of the Exhibit has been omitted pursuant to a request for
Confidential Treatment under Rule 406 of the Securities Act of 1933, as
amended. The Complete Exhibit, including the portions for which confidential
treatment has been requested, has been filed separately with the Securities
and Exchange Commission.
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material only those antigen(s) and/or allergen(s) contained in
COMBINATION but which are not included in TECHNOLOGY.
If the unit invoice price of (i) a separately sold PRODUCT which
contains the antigen(s) and/or allergen(s) which are included in
TECHNOLOGY and/or (ii) a separately sold vaccine which contains
antigen(s) and/or allergen(s) contained in COMBINATION but which are
not included in TECHNOLOGY, is not available and the parties are
unable to agree on an alternative arrangement, the parties shall
agree within 60 days of a request from one of the parties the
appointment of an independent expert ("the Expert") to determine the
relative value of the vaccines described in (i) and (ii) of this
paragraph ("the Vaccine Values"). The Expert shall act as expert and
not as arbitrator and the Expert fee shall be split equally between
the parties. The Expert shall be instructed to take into account a
statement of facts relating to vaccines described in (i) and (ii) as
are agreed by the parties and all relevant market circumstances in
determining the Vaccine Values. The Expert will present to both
parties in writing the determined Vaccine Values together with a
statement justifying the underlying calculations and assumptions.
The decision of the Expert shall be final and binding on the
parties.
If the parties are unable to agree within sixty (60) days the
appointment of an Expert, the following formula shall apply: NET
SALES VALUE of COMBINATION shall be multiplied by a fraction X/Y
wherein X is the number of antigen(s) and/or allergen(s) contained
in PRODUCT which are included in TECHNOLOGY and Y is the total
number of antigens and/or allergens included in COMBINATION.
1.06 "OTHER KNOW-HOW" shall mean technical information, materials and
know-how, excluding OTHER PATENTS, which are owned and/or controlled
by THIRD PARTIES and which are or may become necessary or useful for
the development, production and/or commercialisation of PRODUCT.
1.07 "OTHER PATENTS" shall mean patents and/or patent applications owned
and/or controlled by THIRD PARTIES having claims which would be
infringed by SB making, having made, using, having used, selling or
having sold PRODUCT.
1.08 "PATENTS" shall mean all patents and patent applications which are
or become owned and/or controlled, in whole or in part, by PTL
and/or any AFFILIATES of PTL and under which PTL has, now or in the
future, the right to grant licenses and which generically or
specifically claim PRODUCT and/or use of PRODUCT
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and/or a process for manufacturing PRODUCT, and/or intermediates
used in such process. 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 but subject to
Section 2.08 are any patents or patent applications which
generically or specifically claim or have claims covering any
improvements of PRODUCT or intermediates or manufacturing processes
required or useful for production of PRODUCT which are developed by
PTL, and/or under which PTL otherwise has the right to grant
licenses or sublicenses, now or in the future, during the term of
this Agreement. The current list of patent applications and patents
encompassed within PATENTS is set forth in Schedule A attached
hereto.
1.09 "PRODUCT" shall mean any and all therapeutic and/or prophylactic
vaccine(s) for use in the FIELD in any formulation, configuration,
combination and/or delivery system, which is included in TECHNOLOGY.
1.10 "PTG' shall mean Peptide Therapeutics Group plc a company
incorporated in England and Wales (Registered number 2863682) which
registered office is at 321 Cambridge Science Park, Xxxxxx Xxxx,
Xxxxxxxxx, XX0 0XX, Xxxxxx Xxxxxxx.
1.11 "PTL" shall mean Peptide Therapeutics Limited.
1.12 "SB" shall mean SmithKline Xxxxxxx plc
1.13 "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.
1.14 "SPECIFIC FIELD" shall mean prevention, control and/or treatment of
allergic disorders in humans using []* .
1.15 "TECHNOLOGY" shall mean KNOW HOW and/or PATENTS.
1.16 "TERRITORY" shall mean all the countries and territories in the
world.
1.17 "THIRD PARTY(IES)" shall mean any party which is neither a party to
this Agreement nor an AFFILIATE.
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* This portion of the Exhibit has been omitted pursuant to a request for
Confidential Treatment under Rule 406 of the Securities Act of 1933, as
amended. The Complete Exhibit, including the portions for which confidential
treatment has been requested, has been filed separately with the Securities
and Exchange Commission.
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For the purpose of this Agreement, except as otherwise expressely provided
in this Agreement 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" and other subdivisions and to "Schedules" and "Exhibits" without
reference to a document, are to designated Articles, Sections and other
subdivisions of, and to 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 provisions.
2. RESEARCH COLLABORATION
2.01. Subject to Sections 2.02 and 2.03 hereunder, the parties shall
undertake a two (2) year collaborative research program starting
from the Effective Date (hereinafter "Research Program") dedicated
to the demonstration of technical feasibility and development of
PRODUCT by PTL aimed at inter alia:
[]*
as further outlined in Schedule B attached hereto.
PTL agrees to make available resources in the amount of []* per
year to support the performance of the Research Program and shall
dedicate at least []* annual funding (`Dedication') to the
accomplishment of steps (i), (ii) and (iii) as specified above in
this Section 2.01. At SB's request, PTL will provide written
evidence of such Dedication (`Evidence').
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* This portion of the Exhibit has been omitted pursuant to a request for
Confidential Treatment under Rule 406 of the Securities Act of 1933, as
amended. The Complete Exhibit, including the portions for which confidential
treatment has been requested, has been filed separately with the Securities
and Exchange Commission.
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2.02 Schedule B shall be supplemented within twelve (12) months of the
Effective Date by an additional Schedule (`Schedule D') which will
form part of this Agreement and which shall detail a specific
experimental strategy designed to achieve the broader objectives
outlined in Schedule B.
In Schedule D, SB shall as appropriate revise the objectives and
plans outlined in Schedule B and shall set certain scientific
milestones. In the event such milestones are not achieved as
determined by SB, PTL shall at SB's request, allocate greater or
fewer resources under the Research Program or the Extended Research
Program (as defined in Section 2.03) as the case may be, to any
scientific or developmental objectives including if appropriate
steps (i) to (iv) above identified by SB within the limits stated in
Section 2.01.
2.03 At SB's sole discretion, the Research Program shall be extended by
quarterly periods for []* starting on the second anniversary of the
Effective Date ("Extended Research Program"). To support the
performance of the Extended Research Program SB and PTL shall each
pay []* with period of extension with the same provisions regarding
Dedication and Evidence as detailed above in Section 2.01 or as
modified pursuant to Section 2.02, second paragraph.
2.04 Any further extension and appropriate funding of the Research
Program beyond the Extended Research Program will be subject to
prior written agreement between both parties.
2.05 SB shall have an unconditional and irrevocable option which it may
exercise through written notification to PTL within thirty (30) days
of the expiration of the Research Program or the Extended Research
Program, as the case may be , to discontinue the collaboration with
PTL in the FIELD. In such case, the provisions of Sections 4.02 and
12.03 shall apply.
2.06 SB will conduct all activities related to toxicological and clinical
developments of PRODUCT and such activities shall be under SB's sole
control and expense. PTL shall however use its reasonable endeavours
to seek additional public sector grant funding for such
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* This portion of the Exhibit has been omitted pursuant to a request for
Confidential Treatment under Rule 406 of the Securities Act of 1933, as
amended. The Complete Exhibit, including the portions for which confidential
treatment has been requested, has been filed separately with the Securities
and Exchange Commission.
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activities, such funding to be wholly contributed to the Research
Program or Extended Research Program to the extent allowed by the
grant-giving body.
2.07 During the Research Program and the Extended Research Program if
any, either party shall submit to the other party quarterly progress
reports detailing the research and development work accomplished in
the previous quarter.
2.08 Any invention or discovery in the FIELD made solely by PTL during
the course of the Research Program and Extended Research Program if
any, shall be owned solely by PTL. Any invention or discovery in the
FIELD made solely by SB during the course of the Research Program
and Extended Research Program if any, shall be owned solely by SB.
Any invention or discovery in the FIELD made jointly by PTL and SB
during the course of the Research Program and Extended Research
Program if any, shall be jointly owned by SB and PTL.
2.09 Any patent and/or patent application arising out of an invention or
discovery in the FIELD made solely by an employee or agent of SB
shall be filed in the name of SB. Any patents and/or patent
application arising out of an invention or discovery in the FIELD
made solely by an employee or agent of PTL shall be filed in the
name of PTL and such PATENTS shall be automatically and exclusively
licensed to SB by PTL hereunder. Any patents and/or patent
applications arising out of an invention or discovery in the FIELD
made jointly by SB and PTL shall be filed in the joint names of SB
and PTL, provided that (i) claims covering epitopes from, or
mimetopes of, the constant region of IgE, whether or not coupled to
a carrier shall fall under PATENTS and such PATENTS shall be
automatically and exclusively licensed to SB by PTL hereunder and
(ii) PTL will grant to SB an irrevocable, exclusive, fully paid-up,
royalty free license under PTL's rights to any subject matter other
than mentioned in (i) above contained in such jointly made invention
or discovery.
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3. GRANT
3.01 PTL hereby grants to SB and to any AFFILIATES of SB an exclusive
license, with the right to grant sublicenses, under TECHNOLOGY and
any SPC to make, have made, use, have used, sell, offer for sale,
have sold, keep and/or import in the TERRITORY all subject matter
encompassed within TECHNOLOGY including any and all PRODUCTS,
subject to the terms and conditions of this Agreement.
4. PAYMENTS AND ROYALTIES
4.01 SB shall make the following non refundable payment to PTL : two
million four hundred thousand pounds sterling (L2,400,000)
upon the Effective Date as consideration for the license and rights
granted hereunder.
In addition SB shall grant to PTL an interest free loan of []* for
a duration of up to six (6) months. PTL shall at the expiration of
this loan sell SB []* unencumbered ordinary shares of PTG at a
price of three pounds and sixty xxxxx (L3.60) per share and SB shall
purchase these []* unencumbered ordinary shares of PTG at a price
of three pounds and sixty xxxxx (L3.60) per share according to
the terms of a Subscription Agreement attached hereto as Schedule
C. As also provided for in Schedule C, PTL agrees to undertake
its best efforts to obtain the necessary approvals of PTG
including PTG's shareholder approval to make available these
shares.
In addition SB shall purchase to a value of []* unencumbered
ordinary shares of PTG at a price of three pounds and sixty xxxxx
(L3.60) per share, under the Subscription Agreement attached hereto
as Schedule C, such shares to be tradeable only according to the
provisions of the Subscription Agreement.
4.02 If SB has not exercised its option after the expiration of the
Research Program or the Extended Research Program, as the case
may be, pursuant to Section 2.05 above, SB shall immediately pay
PTL a lump sum (`Licence Maintenance Fee') of []* and this
Agreement shall
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* This portion of the Exhibit has been omitted pursuant to a request for
Confidential Treatment under Rule 406 of the Securities Act of 1933, as
amended. The Complete Exhibit, including the portions for which confidential
treatment has been requested, has been filed separately with the Securities
and Exchange Commission.
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continue in full force and effect. []*
[]*
[]*
4.03 SB shall pay once only the following amounts to PTL upon achievement
of the following Milestones:
[]*
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* This portion of the Exhibit has been omitted pursuant to a request for
Confidential Treatment under Rule 406 of the Securities Act of 1933, as
amended. The Complete Exhibit, including the portions for which confidential
treatment has been requested, has been filed separately with the Securities
and Exchange Commission.
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[]*
For the avoidance of doubt, the maximum Milestones payable,
assuming all Milestones have been achieved, shall be []* .
In Section 4.03 the following terms shall have the meanings defined
below:
[]*
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* This portion of the Exhibit has been omitted pursuant to a request for
Confidential Treatment under Rule 406 of the Securities Act of 1933, as
amended. The Complete Exhibit, including the portions for which confidential
treatment has been requested, has been filed separately with the Securities
and Exchange Commission.
11
[]*
For the avoidance of doubt, if any Submission or Approval covers
more than one of the indications defined above then the Milestone
payments for all the indications covered by such Submission or
Approval shall be payable.
All Submission and Approval Milestones are fully creditable against
current and future royalties provided that such credits shall not
cause the royalties payable in any one calendar year to be reduced
by more than fifty percent (50 %). However any unused credit will be
carried forward to any following calendar year.
4.04 As consideration for the license under PATENTS granted to SB under
this Agreement and subject to Sections 4.06 and 5, SB shall pay the
following royalties ("Patent Royalty") :
[]*
from sales of PRODUCT in countries in which PTL has a granted,
unencumbered, unrevoked PATENT covering such PRODUCT.
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* This portion of the Exhibit has been omitted pursuant to a request for
Confidential Treatment under Rule 406 of the Securities Act of 1933, as
amended. The Complete Exhibit, including the portions for which confidential
treatment has been requested, has been filed separately with the Securities
and Exchange Commission.
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Patent Royalty obligations hereunder in each country of the
TERRITORY shall expire upon the expiration, lapse or invalidation of
the last remaining PATENT covering PRODUCT in such country or
fifteen (15) years from the date of first bona fide commercial sale
of PRODUCT in such country, whichever comes first.
4.05 As consideration for the license to KNOW-HOW granted to SB under
this Agreement and subject to Section 5, SB shall pay to PTL for a
period of ten (10) years from the first bona fide commercial sale of
PRODUCT anywhere in the TERRITORY the following royalties ("Know-How
Royalty") :
[]*
from sales of PRODUCT in countries where PTL has no granted,
unencumbered, unrevoked PATENT covering such PRODUCT.provided that
the making, using or selling of PRODUCT actually uses KNOW-HOW which
is both secret and substantial and has been identified as such by
PTL in writing.
4.06 SB's royalty obligations under Section 4.04 shall become effective
in each country in the TERRITORY at such time as anunrevoked and
unencumbered PATENT covering PRODUCT is granted in such country. In
the event that any person or party initiates any legal proceeding or
proceeding at a competent patent office challenging the validity,
scope or enforceability of a PATENT in any country in the TERRITORY,
then the Patent Royalty payable on NET SALES VALUE in such country
shall, during pendency of the proceeding, be paid into a separate
account (`Escrow Account') of SB from which no amounts can be
withdrawn during such pendency without the prior consent of PTL. The
Escrow
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* This portion of the Exhibit has been omitted pursuant to a request for
Confidential Treatment under Rule 406 of the Securities Act of 1933, as
amended. The Complete Exhibit, including the portions for which confidential
treatment has been requested, has been filed separately with the Securities
and Exchange Commission.
13
Account shall be at a UK bank and the number and address of
the account shall be communicated to PTL. If the validity and
enforceability of claims in the PATENT which cover PRODUCT are
upheld by a court or other legal tribunal or competent patent office
from which no appeal is or can be taken, then the amount of Patent
Royalty paid into the Escrow Account, during the period of
suspension, less any Know-How Royalty paid under Section 4.05, shall
be promptly paid to PTL with any interest earned thereon. If the
claims in the PATENT which cover PRODUCT 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 the amount of
Patent Royalty paid into the Escrow Account with any interest earned
thereon shall be transferred to SB and no further Patent Royalty
shall be owed. Further, a holding of invalidity or unenforceability
of any PATENT, from which no further appeal is or can be taken,
shall not affect any obligation accrued before payment of Patent
Royalty into the Escrow Account, but shall eliminate royalties
otherwise due under such PATENT from the date such holding becomes
final.
4.07 NET SALES VALUE for the purposes of calculating the Patent Royalty
or Know-How Royalty under Section 4.04 and 4.05 respectively shall
be determined separately.
5. COMPULSORY LICENSES AND THIRD PARTY LICENSES
5.01 In the event that a governmental agency in any country or territory
grants or compels PTL, or SB, to grant a license under TECHNOLOGY to
any THIRD PARTY for products that compete with PRODUCT, SB shall
have the benefit in such country or territory (and in any other
country into which products that compete with PRODUCT are sold by
such THIRD PARTY compulsory licensee) of any terms granted to such
THIRD PARTY to the extent that such terms are more favourable to the
THIRD PARTY than those granted to SB under this Agreement.
5.02 The parties recognize that OTHER PATENTS and/or OTHER KNOW-HOW may
exist. (i) If at any time during the term of this Agreement, SB, at
its sole discretion deems it useful or necessary to seek a license
under OTHER PATENTS and/or OTHER KNOW-HOW from any THIRD PARTIES in
order to practice the license granted by PTL to SB hereunder and
avoid infringement during such exercise in a particular country or
(ii) in the event that royalties
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and/or fees are payable by SB to THIRD PARTIES on sales of PRODUCT
(which may include, but shall not be limited to, royalties and/or
fees payable for adjuvants, carriers and/or other technology
included in PRODUCT) other than pursuant to (i) above,such THIRD
PARTY royalties and/or fees shall be deducted from royalties
otherwise due to PTL under Section 4.04 and 4.05 as follows :
- []* of royalties and/or fees payable to THIRD PARTIES shall be
deducted for such royalties and/or fees as are of an amount less
than or equal to []* of that portion of total annual NET SALES
VALUE which exceeds []*; and
- []* of all other royalties and/or fees payable to THIRD PARTIES
shall be deducted.
5.03 Without prejudice to the provision contained in Section 4.03 last
paragraph, no deductions from royalties made under Section 5.02
above may have the effect of reducing royalties otherwise due to PTL
under Section 4.04 by more than []* in any calendar year nor
royalties otherwise due to PTL under Section 4.05 by more
than []* in any calendar year. However any unused credit will be
carried forward to any following calendar year.
5.04 Nothwithstanding Sections 5.02 and 5.03, in the event that (i) SB
establishes by means of written evidence provided to PTL, or (ii)
failing provision of such evidence that the parties agree (such
agreement not to be unreasonably withheld), or (iii) failing such
agreement that a court of competent jurisdiction declares, that
royalties and/or fees are payable by SB to THIRD PARTIES on sales of
PRODUCT and such royalties and/or fees arise from inclusion of the
Immunogen or the Immunogenic Conjugate in PRODUCT, such THIRD PARTY
royalty and/or fee shall be deducted in full from any royalties
payable by SB to PTL
In any negotiation with such THIRD PARTY, SB shall use its
reasonable endeavours to minimise royalties and/or fees payable to
the THIRD PARTY.
For the purposes of this Section 5.05, `Immunogen' and `Immunogenic
Conjugate' shall have the meaning given in the claims of granted
European Patent EP0477231 and in PCT/GB 95/02580 (= W096/14333) as
amended by attorney letter of 18th September 1996, respectively.
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* This portion of the Exhibit has been omitted pursuant to a request for
Confidential Treatment under Rule 406 of the Securities Act of 1933, as
amended. The Complete Exhibit, including the portions for which confidential
treatment has been requested, has been filed separately with the Securities
and Exchange Commission.
15
For the avoidance of doubt, "inclusion of Immunogen in PRODUCT" or
"inclusion of Immunogenic Conjugate in PRODUCT" shall mean that the
PRODUCT including such Immunogen or Immunogenic Conjugate is
susceptible of inducing an immune response to the epitope included
in such Immunogen or Immunogenic Conjugate when presented to the
immune system, whether in admixture with other materials, as a
conjugate or otherwise joined to a carrier entity or molecule
including T-cell epitopes.
For epitopes other than those included in Immunogenic Conjugate or
Immunogen and developed during the Research Programme or Extended
Research Program, the parties shall discuss prior to development of
any such other epitope whether they expect any THIRD PARTY fees
and/or royalties to be due. In the event that the parties have
agreed to proceed with development of such an epitope then such
THIRD PARTY royalty and/or fees payable shall be fully deducted from
any royalties payable by SB to PTL provided that one of the
conditions referred to under (i), (ii) or (iii) in the first
paragraph of this Section 5.05 has been met and SB has used
reasonable endeavours to minimise royalties and/or fees payable to
such THIRD PARTY.
6. TOLERISING PEPTIDE OPTION
6.01 "Clinical Study" shall mean []*
"Clinical Report" shall mean []*
6.02 PTL hereby grants to SB an exclusive option exerciseable as set out
in this Section 6 for a period of two (2) years from the Effective
Date for a worldwide and exclusive license to the TOLERISING PEPTIDE
as described in []*
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* This portion of the Exhibit has been omitted pursuant to a request for
Confidential Treatment under Rule 406 of the Securities Act of 1933, as
amended. The Complete Exhibit, including the portions for which confidential
treatment has been requested, has been filed separately with the Securities
and Exchange Commission.
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[]*
6.03 The option granted in 6.02 shall be exerciseable by SB following
[]*. If a written expression of interest is received by PTL from SB
within three (3) months of []* the parties shall negotiate in
good faith the terms of the licence which will conform to minimum
terms to be agreed by the parties within three (3) months of the
Effective Date. If no such written expression of interest is
received by PTL from SB, PTL will be free to deal in the TOLERISING
PEPTIDE as it sees fit provided however that PTL shall not offer a
licence to the TOLERISING PEPTIDE to any THIRD PARTY within []* of
the termination of such three (3) month period without first
offering such a licence to SB on substantially the same conditions
as those considered for offer to the THIRD PARTY.
7. DEVELOPMENT
7.01 SB will, in accordance with SB's reasonable business and scientific
judgement, exercise its reasonable efforts and diligence in
developing and commercialising PRODUCT and in undertaking
investigations and actions required to obtain appropriate
governmental approvals to market PRODUCT. All such activity shall be
undertaken at SB's expense. At SB's request, PTL shall supply to SB
reasonable technical assistance in undertaking such investigations
and actions.
7.02 SB shall report to PTL on the status and progress of SB's efforts to
develop and commercialise PRODUCT at such times and in such manner
as PTL may reasonably request.
7.03 PTL shall supply any KNOW-HOW which SB may require and shall provide
to SB, at SB's request, technical assistance within its area of
expertise concerning development, production and commercialisation
of PRODUCT. Provision of such technical assistance shall include,
but not be limited to, visits by PTL personnel to SB at PTL's
expense, and visits by SB personnel to PTL, at SB's expense, at
times and for periods of time upon which the parties will agree.
7.04 On completion of the Research Program or the Extended Research
Program, as the case may be, SB agrees, in furtherance of its
obligations under Sections 7.01 and 7.02, to dedicate minimum
resources to developing and
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* This portion of the Exhibit has been omitted pursuant to a request for
Confidential Treatment under Rule 406 of the Securities Act of 1933, as
amended. The Complete Exhibit, including the portions for which confidential
treatment has been requested, has been filed separately with the Securities
and Exchange Commission.
17
commercialising PRODUCT of []* annually. SB agrees to provide
evidence of such dedication on each six (6) monthly anniversary
of the Effective Date following the expiration of the Research
Program or the Extended Research Program as the case may be. In
the event of SB failing to dedicate this annual minimum resources,
PTL shall be entitled to serve written notice to SB pursuant to
Section 12.04.
8. EXCHANGE OF INFORMATION AND CONFIDENTIALITY
8.01 During the term of this Agreement, SB shall have full access to all
matters encompassed within TECHNOLOGY and PTL shall upon the request
of SB promptly disclose and/or supply SB with all TECHNOLOGY.
8.02 During the term of this Agreement, SB shall have full access to (and
PTL will promptly disclose upon request of SB) all technology,
information, inventions, data, process technology and any other
information related to PRODUCTS, whether patentable or not, which
PTL may develop, acquire or otherwise have or obtain rights or
access to, and where appropriate the foregoing shall be subject to
Sections 2.08 and 2.09 above. Either party will at least once a year
disclose to the other party indicative commercial information
related to PRODUCT as follows: general review of progress, size of
target populations, timetable for regulatory approvals and clinical
trial plans. PTL agrees that this information carries no warranty as
to its accuracy and SB is not obliged to proceed to any action based
thereon.
8.03 During the term of this Agreement, each party shall promptly
disclose to the other party any information that it obtains or
develops regarding the utility and safety of PRODUCT 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 PRODUCT.
8.04 During the term of this Agreement and for five (5) years thereafter,
irrespective of any termination earlier than the expiration of the
term of this Agreement, PTL and SB shall not use or reveal or
disclose to THIRD PARTIES any confidential information received from
the other party including that referred to in Sections 7.04, 8.02
and 8.03 or otherwise developed by either party in the performance
of activities in furtherance of this Agreement without first
obtaining the written consent of the other party, except as may be
otherwise provided herein, or as
----------
* This portion of the Exhibit has been omitted pursuant to a request for
Confidential Treatment under Rule 406 of the Securities Act of 1933, as
amended. The Complete Exhibit, including the portions for which confidential
treatment has been requested, has been filed separately with the Securities
and Exchange Commission.
18
may be required for purposes of investigating, developing,
manufacturing or marketing PRODUCT 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
PRODUCT or to carry out any litigation concerning PRODUCT. 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
ensure that no unauthorised use or disclosure is made by others to
whom access to such information is granted.
8.05 Nothing herein shall be construed as preventing either party from
disclosing any information received from the other party to an
AFFILIATE or sublicensee or distributor, provided such AFFILIATE or
sublicensee or distributor has undertaken a similar obligation of
confidentiality with respect to the confidential information.
8.06 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.
8.07 No public announcement or other disclosure to THIRD PARTIES
concerning the existence of or terms of this Agreement shall be
made, either directly or indirectly, by any party to this Agreement,
except as may be legally required or as may be required for
recording purposes, without first obtaining the approval of the
other party and agreement upon the nature and text of such
19
announcement or disclosure, such agreement not to be unreasonably
withheld or delayed. For the avoidance of doubt, the parties agree
that it will be deemed unreasonable for SB to withhold or delay
agreement relating to announcements about achievement of milestones
under Section 4.03 and about the current status (phase) of clinical
trials and it will be deemed reasonable for SB to withhold or delay
agreement relating to announcements describing details of clinical
trials including data. The party desiring to make any such public
announcement or other disclosure shall use reasonable efforts to
inform the other party of the proposed announcement or disclosure in
reasonable sufficient time prior to public release, and shall use
reasonable efforts to provide the other party with a written copy
thereof, in order to allow such other party to comment upon such
announcement or disclosure.
8.08 Neither SB nor PTL 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.
9. PATENT PROSECUTION AND LITIGATION
9.01 Subject to Section 2.08 and 2.09 above, PTL shall be responsible for
the filing, prosecution and maintenance of PATENTS at its own
expense. PTL shall disclose to SB the complete texts of all patents
and patent applications filed and/or controlled by PTL which relate
to PRODUCT as well as all information received concerning the
institution or possible institution of any interference, opposition,
re-examination, reissue, revocation, nullification or any official
proceeding involving a PATENT anywhere in the TERRITORY. SB shall
have the right to review all such pending applications and other
proceedings and make recommendations to PTL concerning them and
their conduct and PTL shall take any such SB comment and
recommendation into consideration. PTL agrees to keep SB promptly
and fully informed of the course of patent prosecution or other
proceedings including the provision to SB of copies of substantive
communications, search reports and THIRD PARTY observations
submitted to or received from patent offices throughout the
TERRITORY. PTL shall provide such patent consultation to SB at no
cost to SB. SB shall hold all
20
information disclosed to it under this section as confidential
subject to the provisions of Sections 8.04 and 8.05.
9.02 SB shall have the right but not the obligation to assume
responsibility for any PATENT or any part of a PATENT which PTL
desires, after consultation with SB, to abandon or otherwise cause
or allow to be forfeited.
9.03 In the event of the institution of any suit by a THIRD PARTY against
PTL, SB or their AFFILIATES or SB's sublicensees or distributors for
patent infringement involving the manufacture, use, sale,
distribution or marketing of PRODUCT anywhere in the TERRITORY, the
party sued shall promptly notify the other party in writing. SB
shall have the right but not the obligation to defend such suit at
its own expense. PTL and SB shall assist one another and cooperate
in any such litigation at the other's request without expense to the
requesting party.
9.04 In the event that PTL or SB becomes aware of actual or threatened
infringement of a PATENT anywhere in the TERRITORY, that party shall
promptly notify the other party in writing. Following expiration of
the Research Program or Extended Research Program, as the case may
be, SB 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 PTL's name in connection therewith. If SB has not
commenced a particular infringement action within ninety (90) days
of notification of any such infringement, PTL, after notifying SB in
writing, shall be entitled to bring such infringement action at its
own expense. During the Research Program or Extended Research
Program, as the case may be, SB and PTL shall agree on bringing
either jointly or solely any infringement action against any THIRD
PARTY and expenses will be shared equally. The party conducting such
action shall have full control over its conduct, including
settlement thereof. In any event, PTL and SB shall assist one
another and cooperate in any such litigation at the other's request
without expense to the requesting party.
9.05 PTL and SB shall recover their respective actual out-of-pocket
expenses, or equitable proportions thereof, associated with any
patent litigation or settlement thereof from any recovery made by
any party. Any excess amount shall be shared between SB and PTL,
with the party conducting a particular infringement action receiving
[]* and the other party receiving []* of such excess.
----------
* This portion of the Exhibit has been omitted pursuant to a request for
Confidential Treatment under Rule 406 of the Securities Act of 1933, as
amended. The Complete Exhibit, including the portions for which confidential
treatment has been requested, has been filed separately with the Securities
and Exchange Commission.
21
9.06 The parties shall keep one another informed of the status of and of
their respective activities regarding any patent litigation or
settlement thereof concerning PRODUCT.
9.07 PTL shall authorise SB to act as PTL's agent for the purpose of
making any application for any extensions of the term of PATENTS and
shall provide reasonable assistance therefor to SB, at PTL's expense
(In the United States of America as permitted under Title 35 of the
United States Code).
9.08 PTL, 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 SB and its
AFFILIATES based upon the exercise by SB of its rights under this
Section 9, except in the case of gross negligence and/or wilful
misconduct by SB.
9.09 SB recognises that bringing an infringement action under Section
9.04 may result in a counterclaim of invalidity of PATENTS and/or
claims in PATENTS. In defending such counterclaim(s), SB agrees to
take into reasonable consideration the legitimate rights and
interests of PTL and/or any licensee(s) of PTL in relation to patent
claims in the field of animal health contained in PATENTS, bearing
in mind SB's prime interest in the maintenance of a strong patent
position covering PRODUCT.
10. TRADEMARKS
10.01 SB, at its expense, shall be responsible for the selection,
registration and maintenance of all trademarks which it employs in
connection with PRODUCT 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 PTL to use such trademarks
for any purpose.
11. STATEMENTS AND REMITTANCES
11.01 SB shall keep and require its AFFILIATES and sublicensees and
distributors to keep complete and accurate records of all sales of
PRODUCT under the licenses granted herein. PTL shall have the right,
at PTL's expense, through a certified public accountant or like
person reasonably acceptable to SB, to
22
examine the records of SB and its AFFILIATES 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 PTL only as to the
accuracy of the royalty statements and payments.
11.02 Within sixty (60) days after the close of each calendar six (6)
month period , SB shall deliver to PTL a true accounting of all
PRODUCTS sold by SB, its AFFILIATES, sublicensees and distributors
during such semester and shall at the same time pay all royalties
due. Such accounting shall show sales on a country-by-country and
product-by-product basis.
11.03 Any tax paid or required to be withheld by SB on account of
royalties payable to PTL under this Agreement shall be deducted from
the amount of royalties otherwise due. SB shall secure and send to
PTL proof of any such taxes withheld and paid by SB for the benefit
of PTL.
11.04 All royalties due under this Agreement shall be payable in pounds
sterling. If governmental regulations prevent remittances from a
foreign country with respect to sales made in that country, the
obligation of SB to pay royalties on sales in that country shall be
suspended until such remittances are possible. PTL shall have the
right, upon giving written notice to SB, to receive payment in that
country in local currency.
11.05 Monetary conversions from the currency of a foreign country in which
PRODUCT is sold into British 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.
12. TERM AND TERMINATION
12.01 Unless otherwise terminated , this Agreement shall expire upon
the expiration, lapse or invalidation of the []* after the
Effective Date, whichever comes later. Expiration of the
Agreement under this Section 12.01 shall not preclude SB from
continuing to
----------
* This portion of the Exhibit has been omitted pursuant to a request for
Confidential Treatment under Rule 406 of the Securities Act of 1933, as
amended. The Complete Exhibit, including the portions for which confidential
treatment has been requested, has been filed separately with the Securities
and Exchange Commission.
23
exercise the rights and licenses granted to it hereunder without any
further royalty or other obligation.
12.02 For the avoidance of doubt, this Agreement may not be terminated by
either party (except under Sections 12.04 or 12.06) during the
Research Period or Extended Research Period.
12.03 This Agreement will terminate if and when SB decides to exercise its
option pursuant to Section 2.05 to discontinue the collaboration
with PTL in the FIELD.
12.04 If either party fails or neglects to perform any material covenants
or provisions of this Agreement and if such default is not corrected
within sixty (60) days 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.
12.05 At any time after the Research Program or Extended Research Program,
as the case may be, SB may terminate this Agreement by giving PTL at
least sixty (60) days written notice thereof.
12.06 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.
12.07 Notwithstanding the bankruptcy of PTL, or the impairment of
performance by PTL of its obligations under this Agreement as a
result of bankruptcy or insolvency of PTL, SB shall be entitled to
retain the licenses granted herein, without any further obligations
to PTL, subject to PTL's right to terminate this Agreement for
reasons other than bankruptcy or insolvency as expressly provided in
this Agreement.
24
13. RIGHTS AND DUTIES UPON TERMINATION
13.01 Upon termination of this Agreement and subject to the provisions
contained in Section 2, PTL shall have the right to retain any sums
already paid by SB hereunder, and SB shall pay all sums accrued
hereunder which are then due.
13.02 Upon termination of this Agreement under Sections 12.04, 12.05 and
12.06, SB shall notify PTL of the amount of PRODUCT SB, its
AFFILIATES and its sublicensees and its distributors then have on
hand, the sale of which would, but for the termination, be subject
to royalty, and SB and its AFFILIATES and its sublicensees and its
distributors shall thereupon be permitted to sell that amount of
PRODUCT provided that SB shall pay the royalty thereon at the time
herein provided for.
13.03 Termination of this Agreement shall terminate all outstanding
obligations and liabilities between the parties arising from this
Agreement except those described in Sections 2.08, 2.09, 8.04, 8.05,
8.07, 8.08, 9.03, 9.06, 9.07, 9.08, 10.01, 11.01, 11.02, 11.03,
11.04, 11.05, 13.01, 13.02, 13.03, 16.01, 17.01 and 19.01.
13.04 Upon termination under Sections12.03, 12.04 (but only in the event
SB is the party in default), 12.05 or 12.06 (but only in the event
SB is the `other party'), and providing SB or an AFFILIATE of SB has
ceased to, or does not, conduct activities in the FIELD, or in any
SPECIFIC FIELD as the case may be, within six (6) months after
termination, PTL shall have a first right to negotiate with SB a
license of rights in such FIELD or SPECIFIC FIELD, to any invention
or discovery owned by SB as are referred to in Sections 2.08 and
2.09.
13.05 Without prejudice to Section 2.09 and Section 12.07, in the case of
termination under Section 12.04 the non-breaching party, or in the
case of termination under Section 12.06 the `other party', or either
party in the case of termination otherwise than under Sections 12.04
and 12.06, shall have the rights to exploit any jointly owned
know-how and /or patents in the FIELD, without any further
obligations to the other party, provided that this grant clause
shall in no event be construed as granting rights to SB to use PTL's
solely owned TECHNOLOGY, nor to PTL to use any of SB's solely owned
know-how,inventions, discoveries
25
and/or patents in the FIELD irrespective of whether jointly owned
patents or know-how relate to the same subject matter, and in the
event such solely owned patents dominate the jointly owned patents
in any manner, the party in need of a licence thereto will have to
seek this licence from the other party independently, and such other
party shall have no obligation whatsoever to come to an agreement
with said party in need
13.06 Nothwithstanding anything to the contrary in this Agreement, the
parties agree that upon termination of this Agreement for any reason
whatsoever, other than a termination under Sections 12.04 or 12.06,
rights to any invention or discovery []* For the avoidance of doubt,
it is acknowledged and agreed by the parties that both parties will
be free to exercise the rights assigned to them under this Section
13.06.
14. WARRANTIES AND REPRESENTATIONS
14.01 PTL warrants that it owns or has the right to license the entire
right, interest and, where appropriate, title in PATENTS and
KNOW-HOW and has the right to enter into this Agreement.
14.02 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. PTL hereby 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.
14.03 PTL acknowledges that, in entering into this Agreement, SB has
relied or will rely upon information supplied by PTL, information to
be supplied by PTL, and information which PTL has caused or will
cause to be supplied to SB by PTL's agents and representatives
pursuant to that certain Confidentiality Agreement signed by SB s.a.
on 6th March 1996 and by PTL on March 11, 1996 , (all of such
information being hereinafter referred to collectively as "Product
----------
* This portion of the Exhibit has been omitted pursuant to a request for
Confidential Treatment under Rule 406 of the Securities Act of 1933, as
amended. The Complete Exhibit, including the portions for which confidential
treatment has been requested, has been filed separately with the Securities
and Exchange Commission.
26
Information"). PTL warrants and represents that so far as it is
aware the Product Information related to PRODUCT and/or TECHNOLOGY
is and will be timely (depending on the circumstances) and accurate
and complete in all material respects and that it has undertaken
such steps as are necessary to ascertain such accuracy and
completeness. Subject to PTL's compliance with its warranty as to
accuracy and completeness above, SB accepts it will not contest
Product Information as supplied. PTL further warrants and represents
that to the best of its knowledge it has and will supply information
concerning TECHNOLOGY and PRODUCT which is material to the value of
the TECHNOLOGY.
14.04 PTL warrants and represents that its directors, scientists, and
allergies project team have no present knowledge of the existence of
any pre-clinical or clinical data or information concerning the
TECHNOLOGY and PRODUCT which suggests that there may exist toxicity,
safety and/or efficacy concerns which are likely to materially
impair the utility and/or safety of the PRODUCT.
14.05 PTL warrants that the agreement between PTL and British Technology
Group Limited ("BTG") of 16th June 1994 has been terminated and that
the intellectual property previously licensed to PTL by BTG under
this agreement has now been fully assigned to PTL. SB acknowledges
it has received a copy of the assignment document (appropriately
redacted to remove any reference to commercial terms) by the
Effective Date.
14.06 PTL agrees it will undertake its reasonable efforts to have
suppliers maintainfor the duration of the Research Program or the
Extended Research Program, as the case may be, supplies of materials
to SB for clinical trial purposes and in particular supplies of
keyhole limpet hemacyanin (`KLH') currently produced by Biosyn GmbH
and of the decapeptide - KLH conjugate currently produced by Biomira
Inc. PTL further agrees it will undertake reasonable efforts to have
such material supplied in a form similar in all respects to material
used previously in clinical studies carried out by PTL or under
PTL's control.
15. FORCE MAJEURE
15.01 If the performance of any part of this Agreement by either party, or
of any obligation under this Agreement, 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
27
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.
16. GOVERNING LAW AND JURISDICTION
16.01 This Agreement shall be deemed to have been made in the United
Kingdom and its form, execution, validity, construction and effect
shall be determined in accordance with the laws of England and shall
be subject to the non-exclusive jurisdiction of the English Courts.
17. SEPARABILITY
17.01 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.
17.02 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.
17.03 In the event that the terms and conditions of this Agreement are
materially altered as a result of paragraphs 17.01 or 17.02, the
parties will renegotiate the terms and conditions of this Agreement
to resolve any inequities.
18. ENTIRE AGREEMENT
18.01 This Agreement, entered into as of the date 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
28
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.
19. NO WAIVER
19.01 The failure of either party at any time to exercise any of its
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.
20. NOTICES
20.01 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 PTL :
Peptide Therapeutics Limited
Cambridge Science Park,
Xxxxxx Xxxx, Xxxxxxxx XX0 0XX
Xxxxxx Xxxxxxx
Attention : The Company's Secretary
Copy to : The Commercial Director
If to SB :
SmithKline Xxxxxxx plc
New Horizons Court
Great Xxxx Xxxx
Xxxxxxxxx, Xxxxxxxxx XX0 0XX
Xxxxxx Xxxxxxx
29
with copy to : SmithKline Xxxxxxx Biologicals Manufacturing X.X.
xxx xx x'Xxxxxxxx 00
0000 Xxxxxxxxx, Xxxxxxx
Attention : Senior Vice President, General Manager
Additional copy to : Vice President, Director
Business and Strategy
Development
20.02 Any notice required or permitted to be given concerning this
Agreement shall be effective upon receipt by the party to whom it is
addressed.
21. ASSIGNMENT AND CHANGE OF CONTROL
21.01 Neither this Agreement nor any interest hereunder shall be
assignable or transferable by either party without the written
consent of the other provided, however, that either party may 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, without obtaining the consent of
the other party provided the interests of the other party are not
materially affected.
IN WITNESS WHEREOF, the parties, through their authorised officers, have
executed this Agreement as of the date first written above.
PEPTIDE THERAPEUTICS LIMITED
BY : Illegible
SMITHKLINE XXXXXXX PLC
BY : Illegible
30
List of Schedules
Schedule A : CURRENT PATENTS
Schedule B : R&D Plan
Schedule C : Subscription Agreement
Schedule D : To be provided within twelve months from Effective Date.
31
Schedule A
[]*
----------
* This portion of the Exhibit has been omitted pursuant to a request for
Confidential Treatment under Rule 406 of the Securities Act of 1933, as
amended. The Complete Exhibit, including the portions for which confidential
treatment has been requested, has been filed separately with the Securities
and Exchange Commission.
SCHEDULE B
[]*
----------
* This portion of the Exhibit has been omitted pursuant to a request for
Confidential Treatment under Rule 406 of the Securities Act of 1933, as
amended. The Complete Exhibit, including the portions for which confidential
treatment has been requested, has been filed separately with the Securities
and Exchange Commission.
