REVISED AND RESTATED MASTER LICENCE AGREEMENT
Exhibit
10.09
Confidential
Treatment - All deleted information contained in this document is information
that Shire Limited. has requested receive confidential treatment pursuant to
Rule 24b-2 promulgated under the Securities Exchange Act of 1934, as
amended. Portions of this agreement which have been deleted have been
replaced by asterisks (“*****”).
REVISED AND RESTATED MASTER
LICENCE AGREEMENT
THIS
AGREEMENT is made the 20th day of November 1995 between
GLAXO GROUP LIMITED,
a company organized and existing under the laws of England and having its
registered office at Glaxo Xxxxxxxx Xxxxx, Xxxxxxxx Xxxxxx, Xxxxxxxxx Xxxxxxxxx
XX0 0XX Xxxxxxx (“GROUP”), together with
GLAXO WELLCOME INC.
(formerly Glaxo Canada Inc.) a corporation organized and existing under the laws
of the Province of Ontario and having its registered office at 0000 Xxxxxxxxxxx
Xxxx Xxxxx, Xxxxxxxxxxx, Xxxxxxx X0X 0X0, Xxxxxx (“GWC”) and
GLAXO WELLCOME INC.
(formerly Glaxo Inc.) a corporation organized and existing under the laws of the
state of North Carolina and having its principal place of business at Five Xxxxx
Drive, Xxxxxxxx Xxxxxxxx Xxxx, Xxxxx Xxxxxxxx 00000, Xxxxxx Xxxxxx of America,
(“GWUS”) and
BIOCHEM PHARMA INC.
(formerly IAF BioChem International Inc.) a corporation organized and existing
under the laws of the Province of Quebec and having an office at 000
Xxxxxx-Xxxxxxxx Xxxx., Xxxxx, Xxxxxx, X0X 0X0 Xxxxxx (“PHARMA”) and
TANAUD HOLDINGS (BARBADOS)
LIMITED, a corporation incorporated under the laws of Barbados and a
wholly owned subsidiary of PHARMA (“THB”)
TANAUD INTERNATIONAL
B.V. a corporation incorporated under the laws of the Netherlands and a
wholly owned subsidiary of PHARMA (“TIB”) and
TANAUD LLC. a limited
liability company incorporated under the laws of the State of Delaware and a
wholly owned subsidiary of PHARMA (“TLLC”)
WHEREAS:
A.
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GROUP,
GWC, GWUS and PHARMA entered into a Master Licence Agreement dated January
31, 1990 as amended by the Addendum to Master License Agreement dated
January 31, 1990, (collectively, the “Original Agreement”) and now
mutually desire to replace and supersede the Original Agreement and to
restate the terms of their agreement herein with effect from November 20,
1995;
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B.
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Since
PHARMA has transferred to THB and TLLC the ownership and/or control over
proprietary rights in certain patents and know-how relating to Modified
Licensed Product (as hereinafter defined) and since THB has assigned and
sold to TIB and TLLC the right to receive royalty payments due to PHARMA
under the Original Agreement, GROUP, GWC, GWUS and PHARMA have added THB,
TIB and TLLC as parties to this
Agreement;
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C.
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PHARMA
desires that Modified Licensed Product be developed and commercialized and
is willing to enter into a licence and other associated agreements for
these purposes;
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D.
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GROUP,
GWC and GWUS desire to collaborate with PHARMA in the development and
commercialization of Modified Licensed Product and PHARMA, THB, TlB and
TLLC are willing to grant rights to GROUP, GWC and GWUS on the terms and
conditions set forth herein and to·enter into a separate agreement with
GWC substantially on the basis of the outline of arrangements set forth in
Schedule 3 hereto.
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NOW IT IS
HEREBY AGREED as follows:
1.
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DEFINITIONS
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For
purposes of this Agreement:
(A)
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“Affiliate”
means any corporation or other legal entity owning, directly or
indirectly, fifty percent (50%) or more of the voting capital shares or
similar voting rights of BIOCHEM or GROUP; any corporation or other legal
entity fifty percent (50%) or more of the voting capital shares or similar
voting rights of which is owned, directly or indirectly, by BIOCHEM or
GROUP; or any corporation or other legal entity fifty percent (50%) or
more of the voting capital shares or similar voting rights of which is
owned directly or indirectly by a corporation or other legal entity which
owns, directly or indirectly, fifty percent (50%) or more of the voting
capital shares or similar voting rights of BIOCHEM or GROUP; or any other
relationship as, in fact, constitutes actual
control
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(B)
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“BIOCHEM”
means PHARMA, THB, TIB and TLLC
collectively.
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(C)
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“Calendar
Quarter” means any period of three (3) months ending on the last day of
March or June or September or
December
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(D)
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“Calendar
Year” means any period of twelve (12) months ending on the last day of
December
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(E)
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“Final
Pharmaceutical Form” means any presentation of a Modified Licensed Product
in any final packaged and labelled pharmaceutical dosage form suitable for
sale to and use by the end-user
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2
(F)
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“FTC”
means
(2R,cis)-4-amino-5-fluoro-1-[2-(hydroxymethyl)-1,3-oxathiolan-5-yl]-2(lH)-pyrimidinone.
Also known as:-
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(2R,5S)-5-fluoro-1-[2-(hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine;
524W91; 5-fluoro-21-deoxy-31.
thiacytidine; FTC.
(G)
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“Independent
Third Party” means any person or entity other than BIOCHEM or GROUP or any
Affiliate or sublicensee of BIOCHEM or
GROUP
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(H)
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“Know-How”
means all information, data, discoveries and trade secrets, whether or not
reduced to writing, pertinent to Modified Licensed Product or to the
manufacture or use of Modified Licensed Product, now or hereafter owned or
controlled by BIOCHEM
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(I)
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“Licensed
Patents” means the patents and patent applications set forth in Schedule 2
hereto, and any patents filed or obtained in any country corresponding to
the patents listed on Schedule 2, as well as any additional patents issued
or granted on additional patent applications in any country relating to
Modified Licensed Product or its method of manufacture or use, or
intermediates therefor, or formulations thereof, and any continuations,
continuations-in-part, divisions, registrations, confirmations, reissues,
renewals or extensions of term thereof, and any registrations or
confirmations of any United States patents listed on Schedule 2 or any
application or any additional United States patents relating to Modified
Licensed Product or its method of manufacture or use, or intermediates
therefor, or formulations thereof, now or hereafter owned or controlled by
BIOCHEM
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(J)
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“Modified
Licensed Product” means
(2R,cis)-4-amino-1-(2-hydroxymethyl-1,3-oxathiolan-5-y1)-(1H)-pyrimidin-2-one
{also known as
4-amino-l-(2R-hydroxymethyl-[1,3]oxathiolan-5S-y1)-(1H)-pyrimidin-2-one;
(2R-cis)-4-amino-1[2-(hydroxymethyl)-1,3-oxathiolan-5-y1]-2-(1H)-pyrimidone;
2’3’-dideoxy,3’-thiacytidine; lamivudine and 3TC}, the corresponding
2S-enantiomer and mixtures of the R- and S-enantiomers in any ratio
including racaemic mixtures.
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(K)
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“Net
Invoiced Sales Value” means the gross invoice price charged for Modified
Licensed Product sold by GROUP or its Affiliates or its sublicensees to an
Independent Third Party, less all allowances or credits granted on·such
sales, including those in respect of rejected or returned goods, recalls,
transportation charges or allowances, insurance charges, normal and
customary trade, quantity and trade discounts, rebates and taxes, other
than income taxes, and other governmental charges on, or measured by, the
sale, transportation, or use of such Modified Licensed Product, which
GROUP and/or its Affiliates and/or its sublicensees has or have to pay or
absorb on such sales
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3
(L)
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“Net
Sales” in any Calendar Quarter
means:
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(i)
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in
the case of any Modified Licensed Product sold in a particular country
hereunder by GROUP and/or its Affiliates and/or its sublicensees in Final
Pharmaceutical Form to an Independent Third Party, uncompounded and not
packaged with any other active therapeutic and/or prophylactic ingredient,
the Net Invoiced. Sales Value of such Modified Licensed
Product;
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(ii)
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in
the case of any Modified Licensed Product sold in a particular country
hereunder by GROUP and/or its Affiliates and/or its sublicensees in Final
Pharmaceutical Form to an Independent Third Party, compounded, packaged or
sold with any other active therapeutic and/or prophylactic ingredient,
such that one price is charged for such combination the value of the total
declared amount of the Modified Licensed Product contained therein as
agreed by discussion between GROUP and PHARMA. If the value cannot be
agreed then it shall be decided by an independent accountant mutually
acceptable to GROUP and PHARMA whose decision shall be binding upon
them;
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For
greater
clarity, the “total declared amount” shall mean the amount of active ingredient
in the Modified Licensed Product as specified on the label or package and as
approved for that dosage form by the governing health authority. For example,
“100 mg” means the total declared value will be 100 milligrams of active
ingredient, even though the actual formula for manufacture and formulation of
such dose of Modified Licensed product may require a different amount of active
ingredient to achieve an effective dose; and
(iii)
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in
the case of any Modified Licensed Product sold in a particular country
hereunder by GROUP and/or its Affiliates and/or its sublicensees in bulk
to an Independent Third Party, the Net Invoiced Sales Value of such
Modified Licensed Product sold by said Independent Third Party in Final
Pharmaceutical Form
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(M)
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“Parties
to the first part of this Agreement” means GROUP, GWC and
GWUS
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(N)
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“Patent
Expenses” means all external fees and
costs
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(i)
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incurred
by GROUP in accordance with the Original Agreement up to November 19,
1995, in financing the patenting activities set forth in Paragraph 8 of
the Original Agreement in relation to Modified Licensed Product and
Residual Product, and
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4
(ii)
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incurred
by GROUP from November 20, 1995 in financing the patenting activities set
forth in paragraph 7 hereof, in relation to Modified Licensed Product
only.
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Patent
Expenses shall include, but shall not be limited to, all official fees and
reasonable independent attorneys’ charges arising from preparation, filing,
prosecution, maintenance and defence [except as arising under the provisions of
subparagraph 7(I)] of the Licensed Patents, and translation charges
(O)
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“Residual
Product” means any compound falling within the general formulae set out in
Schedule 1, but excluding those products covered by the definition of
Modified Licensed Product, and also excluding
FTC.
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(P)
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“Territory”
means all countries of the world except Canada and the
USA.
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(Q)
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“USA”
means the United States of America and its possessions and
territories
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2.
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GRANT OF
RIGHTS
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(A)
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BIOCHEM
hereby grants to GROUP, for all purposes, in the
Territory:
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(i)
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the
exclusive right under Licensed Patents to develop, register, manufacture,
have manufactured, use and sell Modified Licensed Product;
and
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(ii)
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the
exclusive right under Know-How to develop, register, manufacture, have
manufactured, use and sell Modified Licensed Product, including the right
to disclose such Know-How in the circumstances specified in paragraph 8
hereof
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GROUP may
exercise the said rights through its Affiliates and Independent Third Party
consultants, contract manufacturers and distributors: PROVIDED THAT GROUP shall
remain responsible for the performance by such Affiliates, consultants, contract
manufacturers and distributors of any obligations imposed on GROUP by this
Agreement
(B)
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BIOCHEM
hereby grants to GWC in Canada (which term shall include its territories
and possessions):
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(i)
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the
sole right in conjunction with PHARMA under Licensed Patents to develop,
register, manufacture, have manufactured, use and sell Modified Licensed
Product; and
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(ii)
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the
sole right in conjunction with PHARMA under Know-How to develop, register,
manufacture, have manufactured, use and
sell
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5
Modified
Licensed Product, including the right to disclose such Know-How in the
circumstances specified in paragraph 8 hereof
GWC shall
exercise the said rights in the manner described in this Agreement and the
Partnership Agreement set forth in Schedule 3 hereto. Without derogation from
the general applicability of the previous sentence GWC may exercise the said
rights through its Affiliates and Independent Third Party consultants, contract
manufacturers and distributors: PROVIDED GWC shall remain responsible for the
performance by such Affiliates, consultants, contract manufacturers and
distributors of any obligations imposed on GWC by this Agreement
(C)
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BIOCHEM
hereby grants to GWUS in the USA:
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(i)
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the
exclusive right under Licensed Patents to develop, register, manufacture,
have manufactured, use and sell Modified Licensed Product;
and
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(ii)
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the
exclusive right under Know-How to develop, register, manufacture, have
manufactured, use and sell Modified Licensed Product, including the right
to disclose such Know-How in the circumstances specified in paragraph 8
hereof
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GWUS may
exercise the said rights through its Affiliates and Independent Third Party
consultants, contract manufacturers and distributors: PROVIDED THAT GWUS shall
remain responsible for the performance by such Affiliates, consultants, contract
manufacturers and distributors of any obligations imposed on GWUS by this
Agreement.
(D)
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GROUP
in the Territory and GWUS in the USA shall have the right to grant
sublicences of GROUP’s and GWUS’ respective rights under the Licensed
Patents and Know-How: PROVIDED THAT GROUP and GWUS shall each remain
“responsible for the performance by it and by its sublicensees of any
obligations imposed on GROUP or GWUS hereunder. GROUP and GWUS shall
provide BIOCHEM with prior written notice of the identity of any such
proposed sublicensee(s) and shall not formally appoint the organization
identified as a sublicensee unless and until BIOCHEM shall have given its
approval to such appointment, it being understood that such approval shall
not be unreasonably withheld or
delayed
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(E)
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GROUP,
GWUS and GWC grant back to BIOCHEM the rights to the Residual Products
which GROUP, GWUS and GWC held under the Original Agreement: PROVIDED
THAT
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6
(i)
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BIOCHEM
shall not exploit commercially any Residual Product outside the Field
(hereinafter in subclause (E)(v) defined) between
*****
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After
November 19, 1999, if BIOCHEM seeks through an Independent Third Party to
exploit commercially any Residual Product outside the Field, it shall offer to
GROUP a first right to negotiate an exclusive licence for such Residual
Product.
Further,
if GROUP wishes to exploit commercially a Residual Product, GROUP may seek a
licence from BIOCHEM. The terms of such licence, if any, shall be as agreed
between BIOCHEM and GROUP; PROVIDED THAT BIOCHEM shall not be obligated to
entertain discussions or negotiations pertaining to, or conclude, such a license
with GROUP.
(ii)
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BIOCHEM
shall not exploit commercially any Residual Product within the Field until
the patent for such Residual Product
expires.
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(iii)
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BIOCHEM
shall not exploit commercially any compound tested under the Sponsored
Research Agreement dated January 1, 1990 between BIOCHEM and GWC as
amended (the “SRA”) between ***** if BIOCHEM seeks through an Independent
Third Party to exploit commercially any such compound it shall offer to
GROUP a first right to negotiate an exclusive licence for such
compound.
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(iv)
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GROUP
and GWUS shall not exploit commercially any compound within the Field with
the principal purpose of reducing the royalty payable to BIOCHEM under
this Agreement.
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(v)
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In
this paragraph 2(E), a Residual Product or compound shall be regarded as
exploited within the Field if that Residual Product or
compound:
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a) is
a cytidine L nucleoside analogue with no distinct biological difference to
Modified Licensed Product,
b) has
such similar therapeutic properties and such an absence of distinguishing
therapeutic advantages compared to Modified Licensed Product as to be perceived
as clinically interchangeable, and
c) has
its sole clinical use as a direct therapeutic substitute or replacement for
Modified Licensed Product, without any improved ability to compete with other
compounds in the field other than Modified Licensed Product.
Furthermore,
the term “exploited outside the Field”, shall be construed in accordance with
this subclause.
7
(F)
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BIOCHEM
acknowledges that the obligations imposed on BIOCHEM as set out in
paragraph 2(E) mean that BIOCHEM shall not directly or indirectly
manufacture, have manufactured, use or sell, a Residual Product or
compound (for the purposes of this Section 2(F) collectively a “Compound”
other than in accordance with that paragraph. The restriction on use shall
not preclude BIOCHEM from conducting research and development activities
related to Compounds.
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BIOCHEM
acknowledges that where the provisions of paragraph 2(E) require BIOCHEM to
offer to GROUP a first right to negotiate, BIOCHEM shall provide to GROUP a
written notice of BIOCHEM’s intention to exploit a Compound and allow GROUP
thirty (30) days from the date of such notice to provide to BIOCHEM return
written notice indicating whether or not GROUP wishes to enter into negotiations
with BIOCHEM for an exclusive worldwide licence for a Compound, with the right
to sublicense.
Where
GROUP indicates to BIOCHEM in its return notice GROUP’s wish to commence
negotiations, BIOCHEM shall provide to GROUP all relevant information concerning
the Compound to allow GROUP and BIOCHEM to conduct negotiations toward an
exclusive licence agreement for the Compound.
Where
these license negotiations are not completed within ninety (90) days from the
date of GROUP’s receipt of the written notice, or GROUP indicates that it does
not wish to further consider such Compound, BIOCHEM shall be allowed to exploit
such Compound or to grant to an Independent Third party the right to exploit
such Compound; PROVIDED THAT BIOCHEM will not offer more favourable terms to any
Individual Third Party without first offering such more favourable terms
exclusively to GROUP. If BIOCHEM desires to sign with an Independent Third Party
dealing at arm’s length with BIOCHEM a licence containing more favourable terms
than those offered to GROUP hereunder (the “Third Party Offer”), BIOCHEM shall,
once the details of the licence agreement shall have been negotiated between
BIOCHEM and such Independent Third Party, offer (the “GROUP Offer”) to GROUP the
right to execute an exclusive licence agreement upon the same terms and
conditions as those contained in the Third Party Offer. The GROUP Offer and a
copy of the Third Party Offer shall be sent to GROUP and shall be open for
acceptance by GROUP for thirty (30) days from the receipt of the Group Offer by
GROUP. GROUP shall be obliged by notice to BIOCHEM within the said thirty (30)
days, either to accept or refuse the GROUP Offer. If GROUP accepts the GROUP
Offer, GROUP and BIOCHEM shall execute the GROUP Offer immediately following
receipt by BIOCHEM of the notice of acceptance of GROUP. If GROUP refuses the
GROUP Offer or fails to notify BIOCHEM of its decision within the said thirty
(30) days, BIOCHEM shall be free to execute the Third Party Offer.
8
In
determining whether any terms are more favourable than terms offered to GROUP,
regard shall be had to the totality of the terms rather to any single component
or parts thereof.
GROUP,
GWUS and GWC grant back to BIOCHEM the right to FTC which GROUP, GWUS and GWC
held under the Original Agreement
3.
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CONSIDERATION
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(A)
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In
consideration of the rights granted to GROUP herein, GROUP has paid to
PHARMA and TIB collectively in accordance with the Original Agreement the
sum of *****
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(B)
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In
consideration of the rights granted to GROUP herein, GROUP shall pay to
TIB a royalty on GROUP’s Net Sales of any Modified Licensed Product as
follows:
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(i)
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in
each country of the Territory, for so long as there is in that country a
Licensed Patent covering the particular Modified Licensed Product sold in
such country by GROUP or its Affiliates or its sublicensees, the said
royalty shall be ***** Net Sales of that Modified Licensed
Product;
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(ii)
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if
there is no Licensed Patent covering a particular Modified Licensed
Product sold in any country in the Territory by GROUP, or its Affiliates
or its sublicensees, the said royalty shall be ***** of Net Sales of that
Modified Licensed Product, and such royalty shall be paid for a
period of ***** from the date of first commercial sale of that
Modified Licensed Product in that
country;
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(iii)
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if a
Licensed Patent exists in any such country but is declared invalid by a
court of competent jurisdiction from which no appeal has been or can be
made such that it no longer validly covers a particular Modified Licensed
Product sold the said royalty shall be ***** of Net Sales of that Modified
Licensed Product, commencing on the date of declaration of invalidity and
continuing for the balance of the period of ***** from the date of first
commercial sale of that Modified Licensed Product in that country;
and
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(iv)
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upon
the expiration of the last-to-expire Licensed Patent in any country in the
Territory covering a particular Modified Licensed Product sold in such
country by GROUP or its Affiliates or its sublicensees, GROUP shall have
no further royalty obligation for sales in such country of that Modified
Licensed Product
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(C)
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GROUP
shall not be obliged to pay royalties at the full rate set forth in
subparagraph 3(B)(i) on Net Sales of a Modified Licensed Product sold
in
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9
a given
country in the Territory by GROUP, or its Affiliates or its sublicensees, if no
patent covering the manufacture, use, or sale of Modified Licensed Product has
yet proceeded to grant or issue; it being understood and agreed that in such
countries such royalties shall be paid at the reduced rate in accordance with
the provisions of subparagraph 3(B)(ii) until such time as a patent is granted
or issued, covering the manufacture, use, or sale of that Modified Licensed
Product by GROUP or its Affiliates or its sublicensees, whereupon GROUP shall
pay when royalties next fall due under the provisions of paragraph 4 an
additional lump sum royalty of ***** on Net Sales of Modified Licensed Product
sold from the date of commercial sale of Modified Licensed Product in that
country until the date of grant or issue of such patent in that country and
shall pay royalties on Net Sales at the full rate set forth in subparagraph
3(B)(i) for the Modified Licensed Product concerned in the relevant country with
effect from the date of grant or issue of such patent in that
country
(D)
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In
the event that any patent included among the Licensed Patents is declared
invalid by a court of competent jurisdiction from which no appeal has been
or can be made such that it no longer validly covers the Modified Licensed
Product sold, royalties pertaining to that patent shall, from the date of
such declaration, cease to be made at the full rate set forth in
subparagraph 3(B)(i) but shall instead be made at the reduced rate set
forth in subparagraph 3(B)(iii)
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(E)
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The
Patent Expenses incurred by GROUP and ***** of the payments made by GROUP
pursuant to subparagraph 3(A) shall be deducted from royalty payments
arising under subparagraph 3(B) using the following procedure: at the end
of the Calendar Year in which the first commercial sale of a Modified
Licensed Product takes place, the Patent Expenses and ***** being ***** of
the total payments made pursuant to subparagraph 3(A) incurred to date,
shall be calculated and added together to determine the “Royalty Credit.”·
Said Royalty Credit shall be deducted in whole or in part to a maximum of
***** the royalties due in each Calendar Quarter, from the royalties due
for the first Calendar Quarter in which royalties are due, and each
Calendar Quarter thereafter until the total deductions made equal the
Royalty Credit. In the event that the said total deductions made in a
Calendar Quarter do not equal the outstanding balance of the Royalty
Credit, deductions from royalties will continue to be made in each
successive Calendar Quarter in accordance will the aforesaid procedure
until GROUP has recovered the full Royalty Credit. At the end of each
Calendar Quarter, after the Calendar Quarter during which the first
commercial sale of a Modified Licensed Product took place, the Royalty
Credit shall be recalculated by adding to it any further Patent Expenses
incurred during the Calendar Quarter just ended, and subtracting from the
resulting sum the deductions made from royalties during the previous
Calendar Quarter.
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10
Such
Patent Expenses deductions from royalty payments shall be calculated separately
for Modified Licensed Products which are sold for significantly different
indications, such that the Patent Expenses attributable to one indication are
deducted from the royalties payable on Net Sales of Modified Licensed Product
for that indication.
(F)
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If,
in order to manufacture, have manufactured, use or sell Modified Licensed
Product GROUP shall decide following reasonable consultation with BIOCHEM
that it or its Affiliates or sublicensees shall require any
indemnifications relating to, or licenses under, any patents owned in
whole or in part in the Territory by an Independent Third Party which
cover Modified Licensed Product or formulations or uses thereof or
processes for or intermediates used in the manufacture thereof the amount
of the royalty payable to TIB by GROUP on Net Sales of Modified Licensed
Product in the Territory in any Calendar Quarter shall be reduced by the
amount of royalty and/or lump sum payments that GROUP or its sublicensees
shall be required to pay to such Independent Third Party in consideration
of its activities in respect of Modified Licensed Product in that Calendar
Quarter: PROVIDED THAT, irrespective of the number of such arrangements
made with Independent Third Parties, the total permitted royalty reduction
shall not exceed ***** of the amount that would otherwise be payable by
way of royalty by GROUP to TIB on Net Sales of such Modified Licensed
Product in the Territory in the said Calendar Quarter. GROUP
shall provide TIB with documentation of such royalties or such lump sum
payments so paid to any Independent Third
Party
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(G)
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In
consideration of the rights granted to GWUS herein, GWUS has paid to
PHARMA, TIB and TLLC collectively in accordance with the Original
Agreement the sum of *****
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(H)
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In
consideration of the rights granted to GWUS herein, GWUS shall pay to TLLC
a royalty on GWUS’ Net Sales of any Modified Licensed Product as
follows:
|
(i)
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*****
commencing on ***** or sales made until
*****
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(ii)
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*****
commencing on ***** or sales made until December 30, 1998;
and
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(iii)
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*****
commencing December 31, 1998.
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PROVIDED
THAT
|
(a)
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such
royalty rates shall be payable for so long as there is in the USA a
Licensed Patent covering the particular Modified Licensed Product sold in
the USA by GWUS;
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11
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(b)
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if
there is no Licensed Patent covering a particular Modified Licensed
Product sold in the USA by GWUS, the royalty rates applicable to such
Modified Licensed Product shall be reduced to ***** Net Sales of that
Modified Licensed Product respectively, for the relevant time periods set
out above and such royalty rates shall be paid for a period ***** from the
date of first commercial sale of that Modified Licensed Product in the
USA;
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|
(c)
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if a
Licensed Patent exists in the USA but is declared invalid by a court of
competent jurisdiction from which no appeal has been or can be made such
that it no longer validly covers a particular Modified Licensed Product
sold the said royalty rates shall be reduced to ***** of Net Sales of that
Modified Licensed Product respectively, for the relevant time periods set
out above, commencing on the date of declaration of invalidity and
continuing for the balance of the period of ***** from the date of first
commercial sale of that Modified Licensed Product in the USA;
and
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(d)
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upon
the expiration of the last-to-expire Licensed Patent in the USA covering
the particular Modified Licensed Product sold in the USA by GWUS, GWUS
shall have no further royalty obligation for sales in the USA of that
Modified Licensed Product
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(I)
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*****
of the total payments made pursuant to subparagraphs 3(G) hereof shall
constitute a “Royalty Credit” to GWUS. Said Royalty Credit shall be
deducted in whole or in part from the royalties due from GWUS to TLLC in
accordance with the procedure, mutatis mutandis, set forth in subparagraph
3(E). Furthermore the provisions of subparagraph 3(F) shall apply mutatis
mutandis to any arrangements made by or for the benefit of GWUS with
Independent Third Parties. PROVIDED THAT, irrespective of the number of
such arrangements made with Independent Third Parties, the total permitted
royalty reduction shall not exceed a maximum of ***** from GWUS to TLLC on
Net Sales of such Modified Licensed Product in the USA in the said
Calendar Quarter.
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(J)
|
Nothing
contained herein shall obligate GROUP or GWUS to pay royalties on sales of
Modified Licensed Product to its Affiliates or its sublicensees or to pay
more than one royalty on sales of any specific units of Modified Licensed
Product
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4.
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ACCOUNTING
|
(A)
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GROUP
shall deliver to TIB for Net Sales in the Territory, and GWUS shall
deliver to TLLC for Net Sales in the USA, written statements of and the
royalties due thereon in each Calendar Quarter, on or before the thirtieth
(30th) day following the end of that Calendar Quarter.
In
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12
GROUP’s
statements, Net Sales shall be expressed separately for major countries and
convenient groupings of other countries, and separately where Modified Licensed
Product is sold for significantly different indications.
(B)
|
GROUP
shall, on or before the sixtieth (60th) day following the end of each
Calendar Quarter, pay to TIB or to whomsoever BIOCHEM shall direct in
writing in pounds sterling to a bank designated in writing by BIOCHEM (or
in such other currency or manner as may be agreed between the parties from
time to time), the amount of such royalties shown in each written
statement to be due, less any permitted deduction pursuant to subparagraph
3(E) and/or 3(F) hereof. All foreign currencies shall be converted into
pounds sterling or other agreed currency at the rate of exchange published
in the Financial
Times of London or in any other financial source mutually agreed
upon between the parties on the last business day of the Calendar Quarter
in question
|
(C)
|
GWUS
shall, on or before the sixtieth (60th) day following the end of each
Calendar Quarter, pay to TLLC or to whomsoever BIOCHEM shall direct in
writing in United States dollars to a bank designated in writing by
BIOCHEM (or in such other currency or manner as may be agreed between the
parties from time to time), the amount of such royalties shown in each
written statement to be due, less any permitted deduction pursuant to
subparagraph 3(I) hereof.
|
(D)
|
Any
tax which GROUP or its Affiliates or GWUS is required to pay or withhold
with respect to payments to be made to TIB, TLLC or BIOCHEM hereunder
shall be deducted from the amount otherwise due: PROVIDED THAT, in regard
to any such deduction, GROUP shall give BIOCHEM such assistance as may
reasonably be necessary to enable or assist BIOCHEM to claim exemption
therefrom or a reduction thereof and shall upon request provide
documentation from time to time as to confirm the payment of the
tax
|
(E)
|
GROUP
and GWUS shall each keep books and records in sufficient detail to
determine the calculation of royalties payable by GROUP and GWUS
hereunder. Such books and records shall, at·the request and expense of
BIOCHEM, be made available for reasonable review by an independent,
certified public accountant acceptable to both parties for the sole
purpose of verifying the accuracy of the royalty payments made by GROUP
and GWUS under this Agreement: PROVIDED THAT if an inaccuracy in the
royalty payments of greater than five percent (5%) is determined by such a
review the cost of the review shall be borne by GROUP or GWUS. Such review
shall be conducted no more frequently than once per Calendar Year and
shall be scheduled during ordinary business hours. Such books and records
shall be retained by GROUP and GWUS for three (3) years from the date of
their origin: PROVIDED THAT, if a review is
requested
|
13
during the
third year, each such book and record subjected to review shall be retained for
one (1) year beyond the completion of the review
5.
|
EXCHANGE OF
INFORMATION AND REPORTS
|
(A)
|
Promptly
upon execution of this Agreement, BIOCHEM shall, insofar as it has not
already done so, and, insofar as it is not precluded by statute or
regulation, communicate to GROUP all Know-How in its possession at that
time. Thereafter, BIOCHEM shall, insofar as it is not precluded by statute
or regulation, promptly communicate to GROUP all Know-How that it
generates or acquires
|
(B)
|
GROUP
shall promptly provide to BIOCHEM all relevant information related to the
Modified Licensed Product on a timely basis. BIOCHEM shall have prompt
access to marketing plans for Modified Licensed Product through GROUP.
GROUP shall provide to BIOCHEM quarterly written reports on the progress
of the technical development of Modified Licensed Product. GROUP shall
provide BIOCHEM with periodic summary reports on its progress in seeking
regulatory approval for Modified Licensed Product and of plans for launch
of Modified Licensed Product in the USA and in countries of the Territory
and of the anticipated commercial potential therefor in such
countries
|
(C)
|
The
parties will each identify individual employees within their respective
organizations who will be responsible as contacts for the information
exchange activities required herein. Each party will advise the other
parties of the identity of its selected individuals within thirty (30)
days following the signing of this Agreement, and within thirty (30) days
of any change to that selection. The selected individuals will meet at
least three (3) times per year.
|
(D)
|
BIOCHEM
shall promptly provide to GROUP all information in its possession or
control concerning side-effects, injury, toxicity or sensitivity reaction
and incidents or severity thereof associated with all uses, studies,
investigations or tests with Modified Licensed Product (animal or human)
throughout the world, whether or not determined to be attributable to
Modified Licensed Product
|
(E)
|
The
parties will cooperate in arranging scientific meetings, announcing the
results of clinical trials and distributing appropriate information to the
public in a timely manner
|
(F)
|
GROUP
and its Affiliates shall, at their own expense, pursue with reasonable
diligence and use every reasonable effort to develop Modified Licensed
Product for use in treatment of Hepatitis B. Although GROUP shall have the
principal responsibility for the development of
Modified
|
14
Licensed
Product it shall generally cooperate with BIOCHEM in the developmental
activities
6.
|
EXPLOITATION OF
MODIFIED LICENSED PRODUCT
|
(A)
|
GROUP
shall use commercially reasonable efforts to launch Modified Licensed
Product in such countries of the Territory where it believes there to be
significant commercial potential for Modified Licensed Product and it
shall also use commercially reasonable efforts, consistent with GROUP’s
sound and reasonable business practice and judgement, to maximize sales of
Modified Licensed Product in such countries of the
Territory.
|
(B)
|
PHARMA
and GWC shall enter into a Partnership Agreement as set out in Schedule 3
hereto and establish a partnership (hereinafter called “the Partnership”)
to exploit Modified Licensed Product in
Canada.
|
(C)
|
GWUS
shall use commercially reasonable efforts, consistent with GWUS’ sound and
reasonable business practice and judgment, to maximize sales of Modified
Licensed Product in the USA. GWUS will hold the NDA for Modified Licensed
Product but shall make suitable reference to PHARMA in compliance with FDA
requirements, on all packaging and promotional
materials.
|
(D)
|
GROUP
shall supply to GWC at GROUP’s expense any and all supplies of Modified
Licensed Product for
|
(i)
|
clinical
evaluation packages to health care
personnel,
|
(ii)
|
compassionate
use, and
|
(iii)
|
samples
requested by government.
|
(E)
|
GROUP
and GWUS shall be free to set prices for Modified Licensed Product as they
choose taking into account cost of manufacture, market conditions and all
other relevant factors but GROUP and GWUS shall not set such a price with
the principal purpose of reducing the royalties payable to BIOCHEM under
this Agreement.
|
7.
|
PATENTS
|
(A)
|
BIOCHEM
shall undertake and/or continue at the expense of, and in full
consultation with, GROUP or its designated
Affiliate:
|
(i)
|
the
filing of any additional patent applications in the Territory and USA and
Canada based upon patent applications set out in Schedule 2 hereto or
relating to Modified Licensed Products: PROVIDED THAT BIOCHEM shall
consult with GROUP
|
15
regarding
countries in which such additional patent applications should be filed and shall
also file patent applications in those countries where GROUP requests that
BIOCHEM files;
(ii)
|
prosecuting
all pending and new patent applications included within Licensed Patents
and responding to oppositions or any other form of action for invalidity
or revocation of patent rights filed by third parties against the grant of
patents for such applications [except as arising under subparagraphs 7(H)
and 7(I)]; and
|
(iii)
|
maintaining
in force any patents and patent applications included within Licensed
Patents by duly filing all necessary papers and paying any fees required
by the patent laws of the particular country in which such patents were
granted or such patent applications were
filed
|
(B)
|
BIOCHEM
may use independent patent counsel and/or advisors satisfactory to BIOCHEM
and GROUP for the purposes of the activities to be conducted pursuant to
subparagraph 7(A). BIOCHEM shall provide to GROUP copies of all documents
relating to the prosecution of all patent applications. BIOCHEM shall
provide to GROUP every six (6) months a report on its progress in seeking
patent protection pursuant to subparagraph
7(A)
|
(C)
|
BIOCHEM
shall notify GROUP in a timely manner of any decision to abandon a patent
application or an issued patent included within Licensed Patents.
Thereafter GROUP shall have the option of continuing to prosecute any such
patent application or of keeping the issued patent in
force
|
(D)
|
BIOCHEM
shall execute, and BIOCHEM agrees to procure from any inventor(s) or the
beneficiaries or executors of such inventor(s), his or her agreement to
execute all documents and perform all acts, at GROUP’s expense, reasonably
necessary to file, prosecute, maintain and enforce the Licensed
Patents.
|
(E)
|
GROUP
and GWUS shall each be entitled to offset all Patent Expenses incurred by
it under this Paragraph 7 against royalties due under subparagraph 3(B)
and 3(H) respectively, in accordance with the Royalty Credit provisions
set forth in subparagraphs 3(E) and
3(I)
|
(F)
|
GROUP,
GWUS and BIOCHEM shall cooperate fully on all matters relating to the
filing, prosecution and maintenance of Licensed
Patents
|
(G)
|
Recognizing
the interests of the parties in avoiding disclosures that might prejudice
the Licensed Patents, it is hereby agreed that GROUP, GWUS and BIOCHEM
shall have the right to make publications or presentations relating to
Modified Licensed Product PROVIDED THAT the
party
|
16
intending
to publish shall furnish the other with a copy of the manuscript for any
proposed publication or presentation no later than ninety (90) days prior to the
submission of such proposed publication or presentation to a journal, editor, or
other third party for the purpose of review and comment. The other party shall
have the right to request modifications of any manuscript to be published or
presented, if such manuscript will jeopardize a patent application, patent,
trade secret, or other proprietary right relating to this Agreement. If the
party intending to publish does not agree with such modification, the parties
shall consult independent patent counsel satisfactory to both parties, whose
determination shall be binding. Either party shall also have the right to
request a reasonable additional period of time in which to obtain, as necessary
in its sole discretion, additional patent protection, before information
contained in a manuscript is published or presented by the
other
(H)
|
In
the event that BIOCHEM, GROUP or GWUS determines that an Independent Third
Party is making, using, or selling a product that may infringe a Licensed
Patent, it will promptly notify the other party in writing. GROUP or GWUS
may, at its sole option, bring suit against such alleged infringer. In the
event that GROUP or GWUS decides to bring suit, it shall give prompt
written notice to BIOCHEM of that fact, and BIOCHEM shall take all
reasonable steps to assist GROUP or GWUS in such suit. GROUP or GWUS shall
be entitled to all amounts recovered in such suit, except that BIOCHEM
shall have the right to elect to pay up to ***** of the litigation costs
and receive a percentage of any recovery equal to the percentage of
litigation costs paid. BIOCHEM must make such election within sixty (60)
days of its receipt of GROUP’s or GWUS’ notice that GROUP or GWUS
respectively has decided to bring suit. BIOCHEM shall also have the right
to be represented by separate counsel at its own expense in any such suit.
GROUP or GWUS shall have control over any such suit, and decisions as to
settlement, methods and/or terms and conditions for resolving the suit
shall be made by GROUP or GWUS after consultation with BIOCHEM. If GROUP
or GWUS elects not to bring a suit against the alleged infringer, it shall
promptly notify BIOCHEM of that fact, and BIOCHEM shall have the right to
commence such action at its own cost and expense, in which case BIOCHEM
shall be entitled to all amounts recovered in such action. GROUP or GWUS
shall take all reasonable steps to assist BIOCHEM in such
suit
|
(I)
|
In
the event that GROUP or its Affiliates or its sublicensee(s) is or are
sued by an Independent Third Party charging patent infringement for the
manufacture, use or sale of a Modified Licensed Product, GROUP shall
promptly notify BIOCHEM and both parties shall meet to consider a common
strategy for responding to the suit. Failure to agree upon a strategy will
result in the matter being referred to independent patent counsel
satisfactory to both parties whose determination shall be binding. BIOCHEM
shall take all reasonable steps to assist GROUP in
the
|
17
response
to such suit which response shall be progressed by GROUP in full consultation
with BIOCHEM. GROUP shall be entitled to withhold up to ***** of the royalties
otherwise payable to BIOCHEM until such time as the suit is resolved or settled,
and use that withheld royalty to cover external legal defence costs incurred in
such infringement suit. If GROUP avails itself of the provisions of this
paragraph, GROUP agrees to supply BIOCHEM with documentation to confirm the
legal costs incurred
(J)
|
BIOCHEM
shall inform GROUP of any change in the status of any patent related to
Residual Products where such change will entitle GROUP to rights to those
Residual Products in this
Agreement.
|
8.
|
CONFIDENTIALITY
|
Unless
otherwise provided for in this Agreement, the parties shall treat any and all
information and data (including Know-How) received or derived under this
Agreement as strictly confidential, and shall not disclose the same to any
Independent Third Party for the period of thirty (30) years from the date first
above written, except for information which:
(A)
|
is
or shall have been known to the receiving party prior to the disclosure by
the other party as evidenced by written record or other proof;
or
|
(B)
|
is
or shall have been public knowledge through no fault of the receiving
party; or
|
(C)
|
is
acquired lawfully by the receiving party from a third party that has no
confidentiality obligation to the disclosing party;
or
|
(D)
|
the
receiving party needs to disclose to a third party for the purposes of
this Agreement: PROVIDED, HOWEVER, THAT such third party shall be bound by
a similar confidentiality obligation, and the disclosing party shall take
such action as is necessary to procure that any such information revealed
is treated as strictly confidential, including obtaining a signed
confidential disclosure agreement
|
Notwithstanding
the above, the parties may disclose such information:
(i)
|
to
their employees;
|
(ii)
|
in
the case of GROUP and GWUS, to their Affiliates and employees, their
sublicensees and employees and to Independent Third Party consultants and
contractors subject to such consultants and contractors entering into
suitable secrecy agreements with GROUP, GWUS or their Affiliates. GROUP,
GWUS or their Affiliates shall promptly notify BIOCHEM of any such
agreements and provide copies of such agreements to
BIOCHEM;
|
18
(iii)
|
in
the case of GWC, to its Affiliates and employees, and to Independent Third
Party consultants and contractors subject to such consultants and
contractors entering into suitable secrecy agreements with GWC or its
Affiliates. GWC or its Affiliates shall promptly notify BIOCHEM of any
such agreements and provide copies of such agreements to
BIOCHEM;
|
(iv)
|
to
competent government agencies; and
|
(v)
|
as
required by law;
|
to the
extent such disclosure is necessary to achieve the purposes of this
Agreement
9.
|
INDEMNIFICATION
|
(A)
|
GROUP
shall indemnify, protect and hold BIOCHEM and BIOCHEM’s directors,
officers, employees and agents harmless against any and all losses,
damages, fines, costs, expenses (including attorneys’ fees) and
liabilities (including but not limited to claims, actions, legal
proceedings or lawsuits, based on any civil or criminal claims of
liability, including without limitation, negligence, gross negligence,
recklessness, willful misconduct, product liability, strict liability,
breach of express or implied warranty, fraud, misrepresentation, or
violation of any statute, regulation or rule) (referred to collectively as
“Liabilities”), asserted at any time arising out of or involving GROUP’s
or its Affiliates’ or sublicensees’ development, manufacture, use or sale
of Modified Licensed Products. Such indemnification shall not extend to
Liabilities to the extent that they result from the negligence,
recklessness, willful misconduct or fraud of BIOCHEM, its directors,
officers, employees or agents. To the extent such Liabilities result from
the negligence, recklessness or willful misconduct or fraud of or by
BIOCHEM, its directors, officers, employees and agents, BIOCHEM shall
indemnify, protect and hold harmless GROUP and GROUP’s directors,
officers, employees, agents, Affiliates and sublicensees against any and
all such Liabilities
|
(B)
|
A
party seeking indemnification under section 9(A) (hereinafter called the
“Indemnified Party”) shall give prompt written notification to the party
from whom indemnification is sought (hereinafter called the “Indemnifying
Party”) or any claims, actions, legal proceedings or lawsuits for which
the Indemnified Party may assert indemnification from the Indemnifying
Party under this Agreement. The Indemnifying Party shall have the right,
at its own cost to defend any such claim, action, legal proceeding or
lawsuit. The Indemnified Party shall have the right to be represented by
separate counsel at its own expense, in any such claim, action, legal
proceeding or lawsuit. The Indemnifying Party shall have control over any
such suit and any decisions as to settlement,
method
|
19
and/or
terms and conditions for resolving the suit shall be made by the Indemnifying
Party after consultation with the Indemnified Party.
(C)
|
The
Indemnified Party agrees to provide reasonable assistance to the
Indemnifying Party which may be necessary or desirable for the defence
and/or settlement of any such claim, action, legal proceeding or lawsuit.
The Indemnifying Party shall reimburse the Indemnified Party for its
reasonable out-of-pocket expenses related
thereto.
|
10.
|
TERM
|
This
Licence Agreement shall commence with effect from 20 November 1995 and from that
date shall replace the Original Agreement. Unless sooner terminated as provided
herein, this Licence Agreement shall expire
|
(i)
|
upon
the expiration date of the last to expire Licensed Patent,
or
|
(ii)
|
in
the absence of any such Licensed Patent, upon the ***** anniversary of the
date of first commercial sale of Modified Licensed Product by GROUP, or
its Affiliates or its sublicensees, in the particular country in the
Territory wherein GROUP or its Affiliates or its sublicensees last
introduced Modified Licensed
Product.
|
Upon
expiration of this Agreement under this paragraph, *****
11.
|
TERMINATION
|
(A)
|
If
GROUP shall fail to pay to TIB, or GWUS shall fail to pay to TLLC,
royalties as provided under this Licence Agreement for ***** TIB or TLLC
as the case may be, may in its sole discretion, terminate this Licence
Agreement and the licenses granted hereunder after giving GROUP or GWUS as
the case may be, ***** written notice thereof and ***** additional days
for GROUP or GWUS to cure such breach. Such cure shall be effected by
GROUP remitting to TIB, or GWUS remitting to TLLC as the case may be, the
full amount of the unpaid royalties together with interest on said amount
calculated at a rate that is ***** above the base lending rate of the Bank
of Montreal from the date when payment of the outstanding royalties
originally fell due
|
(B)
|
Other
than as provided for in subparagraph
11(A):
|
(i)
|
BIOCHEM
may terminate this Licence Agreement in the event of a material breach by
a party to the first part of this Agreement, PROVIDED ONLY that BIOCHEM
gives to the breaching party written notice of the breach and a reasonable
time, not to exceed ninety (90) days, in which to cure or to take
reasonable steps to cure such breach;
and
|
20
(ii)
|
GROUP
may terminate this Agreement on behalf of the parties to the first part of
this Agreement in the event of material breach by PHARMA, THB, TIB or
TLLC, PROVIDED ONLY that GROUP gives to the breaching Party written notice
of the breach and a reasonable time, not to exceed ***** in which to cure
or to take reasonable steps to cure such
breach
|
(C)
|
This
Agreement shall terminate forthwith on written notice from GROUP to
BIOCHEM or from BIOCHEM to GROUP if BIOCHEM (in the case of a notice from
GROUP) or GROUP (in the case of a notice from BIOCHEM shall make an
assignment for the benefit of creditors, file a petition in bankruptcy,
petition or apply to any tribunal for the appointment of a custodian,
receiver or any trustee for it or a substantial part of its assets, or
shall commence any proceeding under any bankruptcy, reorganization,
arrangement, readjustment of debt, dissolution or liquidation law or
statute of any jurisdiction, whether now or hereafter in effect; or if
there shall have been filed any such petition or application against
BIOCHEM or GROUP, or any such proceeding shall have been commenced against
it, in which an order for relief is entered or which remains undismissed
for a period of thirty (30) days or more; or BIOCHEM or GROUP by any act
or omission shall indicate its consent to, approval of or acquiescence in,
any such petition, application or proceeding or order for relief or the
appointment of a custodian, receiver or any trustee for it or any
substantial part of any or its properties, or shall suffer any such
custodianship, receivership or trusteeship to continue undischarged for a
period of thirty (30) days or more
|
12.
|
RIGHTS ON TERMINATION
OR EXPIRATION
|
(A)
|
If
this Agreement is terminated by BIOCHEM pursuant to subparagraphs 11(A) or
11(B) or is terminated under subparagraph 11(C) as a result of GROUP being
affected by any of the circumstances listed
therein:
|
(i)
|
GROUP
shall promptly return to BIOCHEM all written Know-How provided by BIOCHEM
during the term of this Agreement. GROUP, its Affiliates and sublicensees
shall immediately cease to use and thereafter refrain from using such
Know-How; and
|
(ii)
|
GROUP,
its Affiliates and sublicensees shall promptly transfer all rights and
copies to BIOCHEM of all product registrations, product licence
applications and other drug designations relating to Modified Licensed
Product
|
(B)
|
If
this Agreement is terminated by GROUP pursuant to subparagraph 11(B) or is
terminated under subparagraph 11(C) as a ·result of BIOCHEM or any of its
Affiliates being affected by any of the circumstances listed therein,
GROUP and its Affiliates shall have a non-exclusive,
worldwide,
|
21
paid-up
licence with a right to sublicense under Licensed Patents and Know-How to
manufacture, have manufactured, use and sell Modified Licensed Product and to
disclose Know-How in the circumstances set out in paragraph 8 herein and shall
be without further financial obligation to BIOCHEM
(C)
|
Termination
of this Agreement for any reason shall be without prejudice to the right
of BIOCHEM to receive all royalties accrued and unpaid on the effective
date of termination and shall not relieve either party of any liability or
from any obligations which accrued hereunder prior to such
termination.
|
(D)
|
The
confidentiality obligation set forth in paragraph 8 shall survive the
termination or expiration of this
Agreement
|
13.
|
WARRANTIES
|
(A)
|
BIOCHEM
warrants and represents that the rights granted herein are free of any
encumbrance, and that it has not executed and agrees it will not execute
any agreements inconsistent with or impair the exclusive licenses granted
hereunder
|
(B)
|
BIOCHEM
warrants and represents that all patent applications, patents and Know-How
relevant to Modified Licensed Product hereunder have been disclosed to
GROUP and are included within the definition of Licensed Patents, and/or
Know-How
|
(C)
|
Each
party warrants and represents to the other party that it has the full
right and authority to enter into this Agreement without the consent or
approval of any Independent Third Party and that its obligations and
duties hereunder are not contrary to, or in conflict with, any of its
obligations and duties to any Independent Third
Party
|
14.
|
PUBLICITY
|
No party
shall issue any press release or other publicity materials or make any
representation with respect to the existence of this Agreement or the subject
matter thereof without the prior written consent of the other party. However,
this restriction shall not apply to announcements required by law or regulation
except that in such event the parties shall coordinate to the extent possible
with respect to the wording of any such announcement
15.
|
FORCE
MAJEURE
|
No party
shall be liable to the other for failure or delay in the performance of any of
its obligations under this Agreement for the time and to the extent such failure
or delay is caused by riots, civil commotions, wars, hostilities between
nations, governmental laws, orders or regulations, embargoes, actions by the
government
22
or any
agency thereof, acts of God, storms, fires, accidents, labour disputes or
strikes, sabotage, explosions or other similar or different contingencies, in
each case, beyond the reasonable control of the respective parties (“Force
Majeure”). If the performance of any obligation under this Agreement is delayed
owing to Force Majeure for any continuous period of more than six (6) months,
the parties hereto shall consult with respect to an equitable solution,
including the possible termination of this Agreement
16.
|
SEVERABILITY
|
In the
event that any provision of this Agreement is held by a court of competent
jurisdiction to be unenforceable because it is invalid or in conflict with any
law of any relevant jurisdiction, the validity of the remaining provisions shall
be construed and enforced as if the Agreement did not contain the particular
provisions held to be unenforceable
17.
|
ASSIGNMENT
|
This
Agreement shall not be assignable in whole or in part by either party hereto
except to a successor thereto (or, in the case of GROUP, to an Affiliate)
without the prior written consent of the other party hereto. When duly assigned
in accordance herewith this Agreement shall be binding upon and inure to the
benefit of the successor or assignee
18.
|
AMENDMENT
|
This
Agreement replaces the Original Agreement and all other documents executed or
delivered pursuant thereto, including the documents related to the Original
Agreement listed in Schedule 4 hereto, with effect from November 20, 1995. The
Original Agreement shall be used solely to determine the rights and obligations
as between the parties in existence up to and including 19 November 1995 in
relation to Modified Licensed Product and Residual Product. Schedule 4 hereto
sets out a table of concordance indicating the documents agreements and
schedules related to the Original Agreement, and the documents, agreements and
schedules related to this Agreement.
No
modification or amendment of this Agreement shall be valid or binding upon the
parties hereto unless made in writing and duly executed on behalf of the parties
hereto
19.
|
RELATIONSHIP OF
PARTIES
|
All
parties are independent contractors under this Agreement. Nothing contained in
this Agreement is intended nor is to be construed so as to constitute BIOCHEM or
GROUP as partners or joint venturers with respect to this Agreement except to
the extent contemplated in the Partnership Agreement set out in Schedule 3 to
this Agreement. Neither party hereto shall have any express or implied right or
authority to assume or create any obligations on behalf of or in the name of
the
23
other
party or to bind the other party to any other contract, agreement, or
undertaking with any third party
20.
|
NOTICES
|
All
notices or communications sent or delivered hereunder by one party to the other
party shall be in writing and shall be deemed duly given when delivered to the
other party at the address set out in Schedule 5 hereto or by telecopier to the
number set out on Schedule 5, or at such other address (or to such other person)
as the other party may designate by notice to the said one party
hereunder.
21.
|
WAIVER
|
The
failure on the part of either party hereto to exercise or enforce any right
conferred upon it hereunder shall not be deemed to be a waiver of any such right
or operate to bar the exercise or enforcement thereof at any time or times
thereafter.
22.
|
TITLES
|
The
marginal headings have been inserted for convenience only and do not form part
of this Agreement.
23.
|
DISPUTE SETTLEMENT AND
GOVERNING LAW
|
The
parties agree to attempt to settle any dispute, controversy or difference
arising out of or relating to this Agreement, or breach thereof, by friendly
discussions. If and when any such dispute, controversy or difference is not
settled by such measures, then it shall be decided in accordance with the rules
of the International Chamber of Commerce by a single arbitrator appointed
pursuant to such rules. The parties shall cause such arbitrator to be bound by
confidentiality undertakings substantially equivalent in their effect to those
contained in paragraph 8 hereof. The parties agree to be bound by the award of
such arbitration and that such award may be enforced by any court of competent
jurisdiction. The place of arbitration shall be the city of the respondent party
in any dispute. In the event of multiple respondents involving GROUP and/or GWUS
and/or GWC, the parties to the arbitration agree that the place of arbitration
will be Toronto, Canada unless otherwise agreed to by the parties to the
arbitration. This Agreement shall be construed in all respects and take effect
in accordance with the laws of the Province of Ontario unless otherwise agreed
to by the parties to the arbitration.
24.
|
SRA
|
The
parties hereby confirm that the SRA was extended by the parties to December 31,
1995, in consideration of an aggregate payment by GWC of *****. A final
installment of ***** of the said amount shall be payable on the signing of this
Agreement.
24
25.
|
JOINT and
SEVERAL
|
The
parties acknowledge and agree that all of the covenants, agreements,
representations, warranties and other obligations of BIOCHEM hereunder are joint
and several covenants, obligations, representations, warranties and obligations
of PHARMA, THB, TIB and TLLC.
26.
|
LANGUAGE
|
The
Parties hereto have expressly requested that this Agreement and all related
documents and notices be drafted in the English language. Les parties aux
présentes ont exigé, de façon expresse, que le présent contrat de meme que tous
les documents et avis qui s’y rattachent soient rédigés en langue
anglaise.
IN WITNESS
WHEREOF, the parties hereto have caused this Agreement to be executed on the day
and year first above written.
SIGNED
BY:
GLAXO
GROUP LIMITED
in
the presence of:
|
)
)
)
|
|
SIGNED
BY:
for
and on behalf of
GLAXO
WELLCOME INC. (GWUS)
in
the presence of:
|
)
)
)
)
)
|
|
SIGNED
BY:
for
and on behalf of
GLAXO
WELLCOME INC. (GWC)
in
the presence of:
|
)
)
)
)
|
|
SIGNED
BY:
for
and on behalf of
BIOCHEM
PHARMA INC.
in
the presence of:
|
)
)
)
)
|
|
SIGNED
BY:
for
and on behalf of
TANAUD
HOLDINGS (BARBADOS) LIMITED
in
the presence of:
|
)
)
)
)
)
|
|
SIGNED
BY:
for
and on behalf of
TANAUD
INTERNATIONAL B.V.
in
the presence of:
|
)
)
)
)
|
25
SIGNED
BY:
for
and on behalf of
TANAUD
LLC.
in
the presence of:
|
)
)
)
)
|
26
SCHEDULE
1
“Residual
Product” means any compound falling within the general formula (1) the geometric
and optical isomers thereof, and mixtures of those isomers:
wherein:
R1 is
selected from a group consisting of hydrogen, an acyl group having 1 to 16
carbon atoms, benzoyl and a benzoyl substitued in any position by at least one
halogen, lower alkyl, lower alkoxy, nitro and trifluoromethyl
groups;
R2 is a
heterocyclic radical selected from a group consisting of:
Cont’d/p.2
R3 and R4 are
independently selected from the group consisting of hydrogen and lower alkyl
groups;
RS is
selected from the group consisting of lower alkyl and halogens;
or any
compound falling within the general formula (II), the geometric and optical
isomers thereof, and mixtures of those isomers:
wherein:
R6 is
hydrogen;
R7 is a
purine or pyrimidine base or an analogue or derivative thereof;
Z is
selected from the group consisting of S1 S =O or
SO2;
and
pharmaceutically acceptable derivatives thereof.
SCHEDULE
2
*****
COUNTRY
|
SERIAL
NO.
|
FILING
DATE
|
STATUS
|
*****
|
*****
|
*****
|
*****
|
ARIPO
|
AP/P/90/00163
|
8
February 1990
|
Patent
AP 136
|
*****
|
*****
|
*****
|
*****
|
Australia
|
49201/90
|
8
February 1990
|
Patent
630913
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
European
Patent Designated
Countries:
Austria
Belgium
Switzerland
Germany
Denmark
France
United
Kingdom
Italy
Liechtenstein
Luxembourg
Netherlands
Spain
Sweden
Greece
|
90301335.7
EP
0382526
|
8
February 1990
|
Allowed
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
Hungary
|
708/90
|
7
February 1990
|
Patent
208,134
|
Hungary
/ Pipeline
|
P /
P 00058
|
15
December 1994
|
Patent
210537
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
Page
2
*****
COUNTRY
|
SERIAL
NO.
|
FILING
DATE
|
STATUS
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
Malaysia
|
9000206
|
8
February 1990
|
Patent
MY105523A
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
New
Zealand
|
232421
|
8
February 1990
|
Patent
000000
|
Xxxxxxx
|
31/90
|
8
February 1990
|
Patent
RP 10849
|
*****
|
*****
|
*****
|
*****
|
OAPI
|
59/35
|
8
February 1990
|
Patent
9193
|
Pakistan
|
57/90
|
8
February 1990
|
Patent
132128
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
South
Africa
|
90/0943
|
8
February 1990
|
Patent
90/0943
|
*****
|
*****
|
*****
|
*****
|
Taiwan
|
79101049
|
10
February 1990
|
Patent
050260
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
United
States
|
07/308,101
|
8
February 1889
|
Patent
5,047,407
|
United
States DIV
|
07/716,627
|
17
June 1991
|
Patent
5,151,426
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
COUNTRY
|
SERIAL
NO.
|
FILING
DATE
|
STATUS
|
*****
|
*****
|
*****
|
*****
|
Australia
|
11534/92
|
3
January 1992
|
Patent
660650
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
European
Patent Designated
Countries:
Austria
Belgium
Switzerland
Germany
Denmark
France
United
Kingdom
Italy
Liechtenstein
Luxembourg
Netherlands
Spain
Sweden
Greece
Monaco
Portugal
|
92901354.8
EP
0565549
|
3
January 1992
|
Patent
0565549131
|
*****
|
*****
|
*****
|
*****
|
Germany
|
P69201
94810-08
|
Patent
565549131
|
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
Page
2
*****
COUNTRY
|
SERIAL
NO.
|
FILING
DATE
|
STATUS
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
South
Africa
|
92/0058
|
3
January 1992
|
Patent
92/0058
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
COUNTRY
|
SERIAL
NO.
|
FILING
DATE
|
STATUS
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
Australia
|
16394/92
|
20
May 1992
|
Patent
655973
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
European
Patent Designated
Countries:
Austria
Belgium
Switzerland
Germany
Denmark
France
United
Kingdom
Italy
Liechtenstein
Luxembourg
Netherlands
Spain
Sweden
Greece
Monaco
Portugal
|
92304552.0
EP
0515157
|
20
May 1992
|
Accepted
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
Page
2
*****
COUNTRY
|
SERIAL
NO.
|
FILING
DATE
|
STATUS
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
New
Zealand
|
242817
|
20
May 1992
|
Patent
242817
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
Pakistan
|
240/92
|
21
May 1992
|
Patent
133215
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
South
Africa
|
92/3640
|
19
May 1992
|
Patent
92/3640
|
*****
|
*****
|
*****
|
*****
|
Sri
Lanka
|
10587
|
21
May 1992
|
Patent
10587
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
COUNTRY
|
SERIAL
NO.
|
FILING
DATE
|
STATUS
|
*****
|
*****
|
*****
|
*****
|
ARIPO
|
AP/P/91/00255
|
2
May 1991
|
Patent
AP 182
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
Page
2
*****
COUNTRY
|
SERIAL
NO.
|
FILING
DATE
|
STATUS
|
*****
|
*****
|
Not
confirmed
|
Pending
|
*****
|
*****
|
2
May 1991
|
Pending
|
*****
|
*****
|
20
April 1995
|
Patent
(Number Not Confirmed)
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
Morocco
|
PV
22144
|
29
April 1991
|
Patent
PV22144
|
New
Zealand
|
238017
|
1
May 1991
|
Patent
000000
|
Xxxxxxx
|
71/91
|
30
April 1991
|
Patent
RP 11.263
|
*****
|
*****
|
*****
|
*****
|
OAPI
|
PV
60122
|
2
May 1991
|
Patent
9559
|
Pakistan
|
160/91
|
30
April 1991
|
Patent
132680
|
*****
|
*****
|
*****
|
*****
|
Poland
|
P293181
|
2
May 1991
|
Accepted
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
South
Africa
|
91/3293
|
30
April 1991
|
Patent
91/3293
|
*****
|
*****
|
*****
|
*****
|
Sri
Lanka
|
10346
|
2
May 1991
|
Patent
10346
|
Taiwan
|
80105621
|
19
July 1991
|
Patent
59316
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
Tunisia
|
SN91029
|
2
May 1991
|
Patent
16428
|
*****
|
*****
|
*****
|
*****
|
Page
3
*****
COUNTRY
|
SERIAL
NO.
|
FILING
DATE
|
STATUS
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
GLAXO
WELLCOME INC.
-and-
BIOCHEM
PHARMA INC.
_______________________________
PARTNERSHIP
AGREEMENT
January
1, 1996
_______________________________
INDEX
ARTICLE
1
|
||
INTERPRETATION
|
||
1.1
|
Defined
Terms
|
2
|
1.2
|
General
Definitions
|
4
|
ARTICLE
2
|
||
FORMATION
OF PARTNERSHIP
|
||
2.1
|
Formation
of the Partnership
|
5
|
2.2
|
Purpose
of the Partnership
|
5
|
2.3
|
Interests
of the Partners
|
6
|
2.4
|
Scope
of Authority
|
6
|
2.5
|
Partition
|
6
|
2.6
|
Partnership
Interest of the Partners
|
6
|
ARTICLE
3
|
||
EXPLOITATION
RIGHTS
|
||
3.1
|
7
|
|
3.2
|
Additional
Conveyance Documents
|
7
|
ARTICLE
4
|
||
MANAGEMENT
COMMITTEE
|
||
4.1
|
Function
of the Management Committee
|
7
|
4.2
|
Major
Decisions
|
7
|
4.3
|
Composition
of the Management Committee
|
9
|
4.4
|
Meetings
of the Management Committee
|
10
|
4.5
|
Quorum
of the Management Committee
|
10
|
4.6
|
Decisions
of the Management Committee
|
10
|
4.7
|
Rules
and Regulations
|
11
|
4.8
|
Chairman
|
11
|
4.9
|
Appointment
of a Secretary
|
11
|
4.10
|
Minutes
of Meetings
|
11
|
4.11
|
Technical
and Professional Assistance
|
11
|
(i)
ARTICLE
5
|
||
CAPITAL
ACCOUNTS AND DISTRIBUTIONS
|
||
5.1
|
Capital
Accounts
|
11
|
5.2
|
Increases
to Capital Accounts
|
11
|
5.3
|
Decreases
in Capital Accounts
|
12
|
5.4
|
Allocations
of Profit and Loss
|
12
|
5.5
|
Liquidation
|
12
|
5.6
|
Distribution
Rules
|
12
|
5.7
|
Fiscal
Year
|
13
|
ARTICLE
6
|
||
FINANCING
AND BUDGETING
|
||
6.1
|
Required
Initial Contributions
|
13
|
6.2
|
Additional
Contributions
|
13
|
6.3
|
Books
and Accounts
|
13
|
6.4
|
Audits
|
13
|
ARTICLE
7
|
||
DISPUTE
RESOLUTION
|
||
7.1
|
Final
and Binding Arbitration
|
14
|
7.2
|
Notice
|
14
|
7.3
|
Selection
of Arbitrator
|
14
|
7.4
|
Arbitration
Hearing
|
14
|
ARTICLE
8
|
||
TRANSFERS
AND DISPOSITIONS
|
||
8.1
|
Prohibition
on Transfer
|
15
|
8.2
|
Transfer
to Affiliates
|
15
|
ARTICLE
9
|
||
TERM
|
||
9.1
|
Commencement
of Term
|
15
|
ARTICLE
10
|
||
NOTICES
|
||
10.1
|
Addresses
of Service
|
15
|
(ii)
10.2
|
Change
of Address for Service
|
16
|
10.3
|
Deemed
Receipt
|
16
|
10.4
|
Postal
Interruption
|
16
|
ARTICLE
11
|
||
INDEMNIFICATION
AND SURVIVAL
|
||
11.1
|
BioChcm
Indemnity
|
16
|
11.2
|
Glaxo
Indemnity
|
17
|
11.3
|
Extent
of Indemnification
|
17
|
11.4
|
Claim
|
17
|
11.5
|
Failure
to Defend
|
18
|
11.6
|
Defence
|
18
|
11.7
|
Set-off
|
18
|
11.8
|
Interest
|
18
|
11.9
|
Decisions
|
18
|
ARTICLE
12
|
||
GENERAL
PROVISIONS
|
||
12.1
|
Extension
of Meaning
|
19
|
12.2
|
“Herein”,
etc
|
19
|
12.3
|
Headings
of Articles and Sections
|
19
|
12.4
|
Partial
Invalidity
|
19
|
12.5
|
Entire
Agreement
|
19
|
12.6
|
Governing
Law
|
19
|
12.7
|
Waiver
|
20
|
12.8
|
Amendments
|
20
|
12.9
|
Enurement
|
20
|
12.10
|
English
Language
|
20
|
(iii)
THIS PARTNERSHIP AGREEMENT
made as of the 1st day of January, 1996.
B E T W E
E N:
GLAXO WELLCOME
INC.,
a
corporation amalgamated under the laws of Ontario and having an office at 0000
Xxxxxxxxxxx Xxxx Xxxxx, Xxxxxxxxxxx, Xxxxxxx
(hereinafter
called “Glaxo”)
OF
THE FIRST PART
-and-
BIOCHEM
PHARMA INC.,
a
corporation incorporated under the laws of Quebec and having an office at 000
Xxxxxx-Xxxxxxxx Xxxxxxxxx, Xxxx0, Xxxxxx
(hereinafter
called “BioChem”)
OF
THE SECOND PART
RECITALS
A.
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Pursuant
to the Master Licence Agreement (hereinafter defined) Glaxo was granted
the rights, in conjunction with BioChem, (i) under Licensed Patents
(hereinafter defined) to develop, register, manufacture, have
manufactured, use and sell Modified Licensed Product (hereinafter defined)
in Canada, and (ii) under Know-how (hereinafter defined) to develop,
register, manufacture, have manufactured, use and sell Modified Licensed
Product.
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B.
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Glaxo
and BioChem have agreed to form a partnership for the purpose of
exploiting the rights referred to in the preceding
recital.
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C.
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Glaxo
and BioChem have entered into this Agreement for the purpose of
establishing their respective rights and obligations in relation to the
partnership hereby constituted.
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NOW.
THEREFORE, THE PARTIES AGREE AS FOLLOWS:
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ARTICLE
1
INTERPRETATION
1.1 Defined
Terms. In
this Agreement, unless the context or subject matter is inconsistent therewith,
the following terms and phrases shall have the following meanings:
(a)
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“Additional
Contribution” shall have the meaning ascribed to it in section
6.2.
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(b)
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“Agreement”
means this Partnership Agreement and all of the Schedules attached hereto
and all amendments to this Partnership Agreement as permitted by the terms
of this Partnership Agreement.
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(c)
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“Auditors”
means the chartered accounting firm ***** or such other firm of certified
chartered accountants as may be appointed from time to time by the
Management Committee to be the auditors for the
Partnership.
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(d)
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“Business”
means the business of exploiting the Modified Licensed Products in Canada
under the Licensed Patents as contemplated by and in accordance with the
provisions of the Master License Agreement and this
Agreement.
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(e)
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“Business
Day” means every day except Saturdays, Sundays and days on which banks
located in Ontario or Quebec are not required to be
open.
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(f)
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“Dollars”
and the sign “$” mean lawful money of
Canada.
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(g)
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“Effective
Xxxx” means the 1st day of January,
1996.
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(h)
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“GAAP”
means those accounting principles which are recognized as being generally
accepted in Canada from time to
time.
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(i)
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“Know-how”
means all information, data. discoveries and trade secrets, whether or not
reduced to writing, pertinent to Modified Licensed Product or to the
manufacture or use of Modified Licensed Product. now or hereafter owned or
controlled by BioChem or any of its
affiliates;
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(j)
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“Licensed
Patents” means the patents and patent applications set forth in Schedule
“A” hereto, as well as any additional patents issued or granted or
additional patent applications in the Territory relating to Modified
Licensed Product or its method of manufacture or use, or intermediates
therefor, or formulations thereof; and any divisions, reissues, renewals
or extensions of the term thereof; and any registrations or confirmations
of any patents issued relating to Modified Licensed Product in the
Territory or its method of manufacture or use, or intermediates therefor
or formulations thereof, now or hereafter owned or controlled by BioChem
or its affiliates.
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(k)
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“Major
Decisions” means the decisions with respect to the matters enumerated in
section 4.2 hereof, and when used in the singular, means anyone of such
decisions.
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(l)
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“Management
Committee” means the committee established in accordance with and pursuant
to the provisions of Article 4 of this
Agreement.
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(m)
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“Master
Licence Agreement” means • revised and restated master licence agreement
made as of the 20th day of November, 1995 among Glaxo Group Limited,
Glaxo; Glaxo Wellcome Inc. (formerly Glaxo Inc.), BioChem. Tanaud
International B.V., Tanaud LLC and Tanaud Holdings (Barbados)
Limited.
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(n)
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“Modified
Licensed Product” has the meaning ascribed thereto in the Master Licence
Agreement
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(o)
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“Partners”
means the persons who are party to this Agreement from time to time and
“Partner” shall mean anyone of
them.
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(p)
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“Partnership”
means the partnership established by the Partners pursuant to Article 2 of
this Agreement.
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(q)
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“Partnership
Interest” for each Partner means the undivided percentage interest of such
Partner in the Partnership as set forth in section 2.6 of this
Agreement.
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(r)
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“Partner’s
Representatives” means the persons appointed from time to time by each
Partner to be that Partner’s representatives on the Management Committee
pursuant to section 4.3 of this
Agreement.
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(s)
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“Prime
Rate” means the prime commercial lending rate publicly announced by the
Canadian Imperial Bank of Commerce as its Canadian prime rate as in effect
from time to time.
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(t)
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“Term”
means the term of this Agreement as provided in Article 9
hereof.
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1.2 General
Definitions. In this
Agreement, unless the context or subject matter is inconsistent therewith, the
following terms and phrases shall have the following meanings:
(a)
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“affiliate”
means, with respect to any person, any other person who directly or
indirectly controls, is controlled by, or is under common control with
such first person;
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(b)
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“contract”
means all contracts, agreements, indentures, guarantees, notes, bonds,
leases, mortgages, deeds of trust, licenses, franchises, commitments,
arrangements, sales orders, purchase orders, warranties to third persons,
arrangements, plans or understandings, whether oral or written, express or
implied;
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(c)
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“control”
of any person means:
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(i)
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in
respect of a person, none of whose securities are publicly traded, direct
or indirect beneficial ownership of more than fifty percent (50%) of
voting stock, or more than fifty percent (50%) interest in the income, of
such person; and
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(ii)
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in
respect of a person, any of whose securities are publicly traded, direct
or indirect beneficial ownership of at least thirty-five percent (35%) of
the voting stock;
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and the
words “controlled” and “controlling” and similar expressions have corresponding
meanings. In no event shall one of the Partners be deemed to control the
Partnership;
(d)
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“judgments”
means all judgments, orders, writs, injunctions, rulings and decrees of
any court, governmental authority or arbitration
panel;
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(e)
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“laws”
means all laws, statutes, codes, rules, regulations and ordinances of any
jurisdiction;
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(f)
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“liabilities”
means all liabilities, debts and obligations, whether direct or indirect,
whether absolute, accrued, contingent or otherwise and whether due or to
become due;
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(g)
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“lien”
means any lien, pledge, license, mortgage, security interest, claim,
lease, charge, condition, restriction, assessment, conditional sales
agreement, title retention agreement, hypothec, option, right of first
refusal, pre-emptive right, easement or any other encumbrance whatsoever,
whether direct or indirect, contingent, accrued, absolute or
otherwise;
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(h)
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“person”
means any individual, corporation, partnership, firm, joint venture,
association, joint-stock company, syndicate, trust, unincorporated
organization, business enterprise or other entity;
and
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(i)
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“property”
means all assets, properties and business, real, personal or mixed,
tangible or intangible, moveable or immoveable, including the goodwill of
a person.
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ARTICLE
2
FORMATION OF
PARTNERSHIP
2.1 Formation of the
Partnership. The
Partners hereby agree to form a partnership under the laws of the Province of
Ontario as of the Effective Date. The Partnership shall operate under the name
of Glaxo Wellcome BioChem or such other name as the Partners may agree upon from
time to time. The Partnership shall conduct the Business in accordance with the
terms and conditions of this Agreement. The Partners hereby agree that this
Agreement shall govern and define the respective rights and obligations of the
Partners as partners in the Partnership. The principal office of the Partnership
shall be located at 0000 Xxxxxxxxxxx Xxxx Xxxxx, Xxxxxxxxxxx, Xxxxxxx X0X 0XX or
at such other location as the Management Committee may determine from time to
time.
2.2 Purpose of the
Partnership. The
purpose and scope of the Partnership shall be limited to:
(a)
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the
operation of the Business;
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(b)
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such
other purposes as may be mutually agreed upon from time to time by the
Partners; and
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(c)
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all
other things necessary or appropriate for the accomplishment of the
foregoing purposes.
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2.3 Interests of the
Partners. All
Partnership properties shall be owned by the Partnership and no Partner shall
have any ownership interests therein. Except as otherwise provided in this
Agreement, each Partner shall, in proportion to its respective Partnership
Interest:
(a)
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contribute
and be liable for its share of the liabilities of the Partnership;
and
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(b)
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be
entitled to the rights and benefits of the
Partnership.
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2.4 Scope of
Authority. A
Partner shall not be responsible or liable for any liability incurred by the
other Partner before or after the execution hereof; except with regard to those
liabilities relating to the Partnership incurred or assumed pursuant to the
terms of this Agreement. Except as provided ‘pursuant to the terms of this
Agreement. a Partner shall not have any authority to act for, to bind or to
assume any obligation or responsibility on behalf of the other Partner or on
behalf of the Partnership. Each Partner covenants and agrees with the other
Partner to indemnify and save harmless such other Partner in accordance with
Article 11 from any and all liabilities whatsoever resulting from any
unauthorized acts of such indemnifying Partner with respect to the
Partnership.
2.5 Partition. A
Partner shall not have the right to partition Partnership property or any part
thereof; nor shall any Partner make any application to a court having
jurisdiction over the matter, or commence or prosecute any action for partition,
and each Partner shall, in addition to all other rights and remedies in law and
in equity, be entitled to a decree or order restraining and enjoining such
application, petition, action or proceeding, and the Partner in breach of this
section 2.5 shall not plead in defense thereto that there would not be another
remedy at law adequate to meet such breach, it being recognized and agreed that
the injury and damage resulting from such breach would be difficult, if not
impossible, to measure monetarily and each Partner hereby expressly waives any
right to partition that is provided to it pursuant to any law.
2.6 Partnership Interest of the
Partners.
Initially, the respective Partnership Interests of the Partners are as
follows:
(a)
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as
to Glaxo, an undivided fifty percent (50%) interest;
and
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(b)
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as
to BioChem, an undivided fifty percent (50%)
interest.
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The
aforesaid undivided interests may be varied from time to time only with the
consent of the Partners.
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ARTICLE
3
EXPLOITATION
RIGHTS
3.1 Master Licence
Agreement. The
Partners hereby acknowledge and agree that the Partnership is the partnership
referred to in the Master Licence Agreement, formed for the purpose of
exploiting the Modified Licensed Product in Canada as contemplated under
Sections 2B and 6B of the Master Licence Agreement
3.2 Additional Conveyance
Documents. The
Partners shall execute and deliver to the Partnership such other good and
sufficient instruments of conveyance, assignment and transfer, in form and
substance satisfactory to the Partners, and shall take such actions as the
Partners may deem necessary or desirable in order to more effectively transfer,
convey and assign to the Partnership, and to confirm the Partnership’s title to
exploitation rights granted to the Partners pursuant to the Master Licence
Agreement.
ARTICLE
4
MANAGEMENT
COMMITTEE
4.1 Function of the Management
Committee. There
shall be a Management Committee of the Partnership which shall exercise overall
supervision and control of the Partnership and shall determine all Major
Decisions.
4.2 Major
Decisions. Major
Decisions shall be as follows:
(a)
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the
approval of all operating and capital budgets, forecasts, capital plans
and long-range plans in respect of the operation of the Business and all
amendments thereto and variations
therefrom;
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(b)
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the
making of any capital expenditure in any amount, if not included in an
approved budget, exceeding $10,000 for anyone capital expenditure in any
calendar year of the Term, exceeding $30,000 in the aggregate for all such
capital expenditures made in that calendar year or any capital expenditure
(even if included in an approved budget) in excess of $50,000; provided
that for purposes of this section 4.2(b) expenditures for related items
shall be aggregated and deemed to be one (1)
expenditure;
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(c)
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the
appointment of the Auditors and the settlement of any questions or the
approval or disapproval of any recommendations based upon or arising out
of any audit of the Partnership’s books and records, the approval of the
audited annual financial statements of the Partnership and the approval of
the Auditors’ fees;
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(d)
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the
appointment or designation of committees or sub-committees to study any
issue in connection with the
Business;
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(e)
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the
transfer of any asset of the Partnership out of the ordinary course of
business of the Partnership having a cost or a fair market value in excess
of $50,000, unless provision therefore is contained in an approved budget;
provided that for purposes of this section 4.2(e), transfers of related
items shall be aggregated and deemed to be one (1)
transfer;
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(f)
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the
surrender or termination of any contract unless provision therefore is
contained in an approved budget;
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(g)
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the
approval of all matters concerning pay scales and employee and consultants
arrangements;
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(h)
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the
approval of the terms and conditions of any contracts made between the
Partnership and a Partner or any affiliate of a Partner and any amendments
to such contracts, including, without limiting the generality of the
foregoing, approval of any proposed change in the purchase price payable
from time to time by the Partnership to Glaxo for Modified Licensed
Product purchased under the supply agreement for Modified Licensed
Product, to meet the Partners’ objective for each year commencing January
1, 1998 that the profit earned by Glaxo in supplying Modified Licensed
Product to the Partnership will equal the profit earned by BioChem under
its marketing agreement with the
Partnership;
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(i)
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the
granting of a lien on any Partnership
property;
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(j)
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the
approval of the incurrence on behalf of the Partnership of any debt or any
refinancing of debt on behalf of the Partnership other than trade accounts
payable incurred in the normal course of business consistent with prior
practice;
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(k)
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the
commencement, prosecution or defense of any actions or proceedings
relating to a third party dispute and the approval of the settlement or
other resolution of any such dispute; provided, however if any such action
or proceeding involves a Partner or any of its affiliates in a position
adverse in interest to the Partnership, any action or decision relating
thereto shall be taken or made by the other Partner on behalf of the
Partnership;
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(l)
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the
approval of the accounting principles and any changes to such accounting
principles to be applied by the
Partnership;
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(m)
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the
entering into of any business by the Partnership other than the Business
and all matters relating to such new
business;
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(n)
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the
making of loans to any person or the entering into of contents of
guarantee or indemnity with respect to the liabilities of any
person;
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(o)
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the
approval of Additional Contributions to be made by the
Partners;
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(p)
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the
hiring of persons as employees of the Partnership and the designation of
any person as Chief Medical Officer or any other officer of the
Partnership together with the terms of authority and responsibility of
such persons;
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(q)
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distributions
to the Partners;
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(r)
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the
approval of the Partnership’s annual operating plan (including the sales,
marketing, personnel and operating plan and budget) and amendments
thereto; and
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(s)
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any
other decision or action which by the provisions of this Agreement, or any
other contract, is required to be approved by the Management Committee or
which the Management Committee determines should be subject to its
approval.
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4.3 Composition of the
Management Committee. The
Management Committee shall be composed of four (4) persons, two (2) being
Partnership Representatives appointed by Glaxo and two (2) being Partnership
Representatives appointed by BioChem. The initial Partnership Representatives
are as follows:
Partner
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Partnership
Representatives
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Glaxo
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Xxxx
Xxxxx
Xxxx
L’Archeveque
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BioChem
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Xxxxxxxxx
Xxxxxxx
Xxxxxxx
Xxxx
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The
Partners may appoint alternate persons to act as their Partnership
Representatives. The notice of appointment of Partnership Representatives or
alternates to the Management Committee or the notice of any change in the
Partnership Representatives or alternates so appointed shall be given by one
Partner to the other Partner by a notice in writing. The Partnership
Representatives and alternates shall be authorized to represent and bind
the
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Partners
at meetings of the Management Committee. Each Partner may remove or replace any
of its Partnership Representatives or alternates by notice to the other
Partner.
4.4 Meetings of the Management
Committee. There
shall, unless otherwise agreed by the Partners, be quarterly meetings of the
Management Committee. Meetings shall be held alternately at the offices of each
of the Partners at the times determined by the Management Committee. Either
Partner may call a special meeting of the Management Committee upon five (5)
Business Days’ notice, with agenda attached, to the other Partner. Such special
meetings shall be held at such location as the Partners may agree upon or,
failing agreement, at the offices of the Partner on whom the notice is served.
Other meetings of the Management Committee may be held at such times and at such
places as may be agreed upon by the Partners. The Partners may jointly waive the
requirement for notice of a meeting of the Management Committee. Management
Committee meetings may be held by conference telephone whereby each person
participating is able to hear and be heard by the other persons participating.
No compensation or reimbursement of expenses shall be paid by the Partnership to
the Partnership Representatives or alternates.
4.5 Quorum of the Management
Committee. A quorum
of the Management Committee shall consist of one (1) Partnership Representative
or alternate of Glaxo and one (1) Partnership Representative or alternate of
BioChem. There shall be a total of two (2) votes on the Management Committee and
the Partnership Representatives or alternates of Glaxo shall collectively have
one (1) vote and the Partnership Representatives or alternates of BioChem shall
collectively have one (I) vote. The Management Committee shall not conduct any
business at meetings of the Management Committee when there is not a quorum
present at such meeting except as otherwise provided in this Agreement
Notwithstanding the foregoing, if none of the Partnership Representatives or
alternates of a Partner attend at a properly convened Management Committee
meeting, then the quorum required for such a Management Committee meeting shall
be one (I) Partnership Representative or one (1) alternate of Glaxo or BioChem,
as the case may be.
4.6 Decisions of the Management
Committee.
Decisions of the Management Committee must be approved by unanimous vote at
meetings of the Management Committee or by a resolution in writing signed by at
least one (1) Partnership Representative or alternate of Glaxo and one (1)
Partnership Representative or alternate of BioChem. The Management Committee
shall make its decisions solely in the best interests of the Partnership and
within a period of time such !bat the Partnership may proceed without undue
delay, having regard to the objectives and contractual commitments of the
Partnership.
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4.7 Rules and
Regulations. The
Management Committee may fix such rules and procedures as are necessary to carry
out its duties hereunder in addition to those rules set forth
herein.
4.8 Chairman. During
the Term, the Partners shall appoint a person to act as chairman (the
“Chairman”) of the Management Committee, with the Chairman alternately being a
Partnership Representative of Glaxo and BioChem. Each Chairman shall serve for a
one (1) year term, provided that the first Chairman shall serve from the
Effective Date through December 31, 1996. The first Chairman shall be a
partnership Representative of Glaxo. The Chairman shall be responsible for
conducting meetings of the Management Committee. The Chairman shall not, in any
event, have a casting vote.
4.9 Appointment of a
Secretary. The
Management Committee shall appoint a secretary for the Management Committee or.
failing agreement upon a secretary. the Chairman shall have the power to
designate a secretary, who need not be a member of the Management Committee.
Minutes in summary form shall be kept of the proceedings at meetings of the
Management Committee and of the matters decided thereat.
4.10 Minutes of
Meetings. Minutes
of each meeting of the Management Committee shall be distributed to each
Partner, addressed to the attention of the Partnership Representatives. The
minutes shall be deemed to be an accurate record of the meeting and the
disposition of the matters raised thereat, unless any Partner objects thereto
within twenty (20) Business Days after the minutes are received by the Partner
or, if the next meeting of the Management Committee is earlier, at such meeting.
If an objection is raised by a Partner following receipt of the minutes, but is
not raised at the next ensuing meeting of the Management Committee, the
objection will be deemed to have been withdrawn.
4.11 Technical and Professional
Assistance. At
meetings of the Management Committee, Partnership Representatives and alternates
may be accompanied by technical and professional personnel whose advice may be
required for the business an the agenda, but such personnel shall not be
entitled to vote.
ARTICLE
5
CAPITAL ACCOUNTS AND
DISTRIBUTIONS
5.1 Capital
Accounts.
Throughout the Term, the Partnership shall maintain a separate Capital Account
for each Partner (the “Capital Accounts”).
5.2 Increases to Capital
Accounts. Each
Partner’s Capital Account shall be increased by:
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(a)
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the
amount of money contributed by such Partner to the
Partnership;
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(b)
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the
fair market value of property contributed by such Partner to the
Partnership (net of liabilities secured by the contributed property that
the Partnership assumes or takes subject to);
and
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(c)
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allocations
to such Partner of Partnership income, including realized capital
gains.
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5.3 Decreases in Capital
Accounts. Each
Partner’s Capital Account shall be decreased by:
(a)
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the
amount of money distributed to such Partner by the
Partnership;
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(b)
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the
fair market value of property distributed to such Partner by the
Partnership (net of liabilities secured by such distributed property that
such Partner assumes or takes subject to);
and
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(c)
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allocations
to such Partner of Partnership
losses.
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5.4 Allocations of Profit and
Loss. Profits
and losses of Partnership and any other allocations not otherwise provided for
shall be allocated among the Partners in proportion to their respective
Partnership Interest.
5.5 Liquidation.
(a)
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Upon
dissolution, the Partners shall sell or otherwise convert all property of
the Partnership into cash or receivables (or transfer the same in
satisfaction of Partnership obligations) and, after payment or making
provisions for payment, when due, of any debts of the Partnership,
including, without limitation, debts to Partners who are creditors of the
Partnership, shall distribute all proceeds thereof to the Partners,
subject to any liabilities of the Partnership, in proportion to their
respective Capital Accounts.
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(b)
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Upon
the dissolution of the Partnership, each Partner will contribute to the
Partnership an aggregate cash amount equal to the deficit balance in such
Partner’s respective Capital Account not later than ninety (90) days after
the date of liquidation of the Partnership or the end of the taxable year
in which the liquidation occurs, whichever is
later.
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5.6 Distribution
Rules. The
amount of cash flow, if any, that is surplus to the operational requirements of
the Partnership from time to time shall be determined
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by the
Management Committee and shall be distributed to the Partners in proportion to
their allocation of profit and loss set forth in section 5.4 hereof at such
times as the Management Committee determines.
5.7 Fiscal
Year. The
fiscal year of the Partnership shall be the calendar year.
ARTICLE
6
FINANCING AND
BUDGETING
6.1 Required Initial
Contributions. Each
Partner shall make the following cash contributions to the
Partnership:
Glaxo - $1,000
BioChem
- $1,000
6.2 Additional
Contributions. The
Partners shall contribute all funds required from time to time for the purposes
of the Partnership in excess of the funds provided for pursuant to section 6.1
hereof and the Cash flow generated from the operations of the Partnership (the
“Additional Contributions”). Additional Contributions may take the form of debt
or capital contributions, as the Management Committee may determine. Each
Partner shall contribute its share, in accordance with its Partnership Interest,
of any Additional Contributions, without deduction or set-off, within ten (10)
Business Days after receipt of a notice from the Management Committee requesting
the payment of such Additional Contributions.
6.3 Books and
Accounts. The
Partnership shall keep proper accounts of all transactions of the Business,
including financial records and statements prepared in accordance with GAAP
consistently applied. The accounts so maintained shall at all times be in
sufficient detail to enable the Partners to keep accounts in accordance with the
requirements of the applicable regulatory bodies and GAAP and to file financial
reports and tax returns in accordance with such requirements.
6.4 Audits. Regular
audits of the books and records of the Partnership shall be conducted once each
calendar year. The costs of such audits shall be for the account of the
Partnership. Each such audit shall be conducted by the Auditors or such other
independent firm of chartered accountants appointed from time to time by the
Management Committee. Upon conclusion of an audit, a copy of the audit report
shall be furnished, within two (2) months, to each Partner and proposed
adjustments will be referred to the Management Committee for appropriate
adjustments and adjustments approved by the Management Committee shall be made.
In the event that the Management Committee does not make an adjustment
recommended in the audit report and in the further event that one of the
Partners
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gives
notice in writing to the other Partner that it believes such adjustment should
be approved by the Management Committee, then the Management Committee shall
retain a firm of chartered accountants and that firm of chartered accountants
shall review the matter and shall advise the Management Committee and the
Partnership shall be bound by the decision of such firm. Each Partner shall also
be entitled to audit the books and records of the Partnership at such Partner’s
own expense.
ARTICLE
7
DISPUTE
RESOLUTION
7.1 Final and Binding
Arbitration. In the
event of any claim, dispute or controversy between the Partners relating to this
Agreement, the matter shall be resolved by final and binding arbitration in
Toronto, Canada in accordance with the provisions of this Article 7 and there
shall be no appeal therefrom.
7.2 Notice. It shall
be a condition precedent that the right of any Partner to submit a matter to
arbitration pursuant to the provisions hereof to give not less than ten (10)
days prior notice to the other Partner of its intention to do so. Upon the
expiration of such ten (10) day period, the Partner who has given such notice
may proceed to refer the dispute to arbitration as provided herein.
7.3 Selection of
Arbitrator. The
Partner entitled to refer a matter to arbitration shall proceed to refer the
matter to arbitration by appointing one (I) arbitrator and notifying the other
Partner of such appointment. The other Partner shall, upon receiving such
notice, appoint a second arbitrator, and the two (2) arbitrators shall within
fifteen (15) days of the appointment of the second arbitrator agree upon the
appointment of a third arbitrator who will act with them and be chairman of the
panel In the event that a Partner shall fail to appoint an arbitrator within
thirty (30) days of commencement of the arbitration proceeding, the arbitrator
shall be appointed by a judge of the Ontario Court (General Division). In the
event of a failure of the said two (2) arbitrators to agree within sixty (60)
days after commencement of the arbitration proceedings upon the appointment of a
chairman, the chairman shall also be appointed by a judge of the Ontario Court
(General Division) on application by either Partner.
7.4 Arbitration
Hearing. In any
arbitration pursuant to this Agreement, the award or decision shall be rendered
by a majority of the members of the panel provided for herein. The chairman
shall fix a time and place in Toronto within twenty (20) days of his appointment
for the purpose of hearing evidence and representations of the parties and shall
preside over the arbitration and shall determine all questions of procedure not
provided for herein in accordance with the Arbitration Act (Ontario). After
hearing any evidence and representations that
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each
Partner may submit, the arbitrator shall make an award and reduce the same to
writing and deliver one (1) copy to each Partner within ten (10) days after the
hearing. Judgment upon the award rendered by the arbitrators may be entered in
any Court having jurisdiction thereof; provided, however, that the law
applicable to any controversy shall be the law set forth in section 12.6. The
cost of arbitration shall be paid as specified in the award unless otherwise
agreed to by the Partners.
ARTICLE
8
TRANSFERS AND
DISPOSITIONS
8.1 Prohibition on
Transfer. Except
as otherwise provided in this Article 8, a Partner shall not transfer its
Partnership Interest, in whole or in part. Any transfer of a Partnership
Interest shall be void and without effect unless made in accordance with the
provisions of this Article 8 or with the prior approval in writing of the
Partners.
8.2 Transfer to
Affiliates.
Notwithstanding section 8.1 hereof; either Partner may transfer all or part of
its Partnership Interest to an affiliate of that Partner (other than a company
that is an affiliate by virtue of the definition of “control” in section
l.2(c)(ii) hereof) provided that such affiliate becomes a party to this
Agreement and in the event of such transfer, the Partner effecting the transfer
of all or part of its Partnership Interest to its Affiliate shall remain fully
obligated to observe and perform all of its obligations under this Agreement.
For purposes of this Agreement, such Partner and affiliate shall collectively be
deemed to be one (1) partner.
ARTICLE
9
TERM
9.1 Commencement of
Term.
Notwithstanding the date of execution of this Agreement, this Agreement shall
commence on the Effective Date and unless sooner terminated with the consent of
the Partners shall continue until the first anniversary date of the expiry of
the Licensed Patents which provide for market exclusivity of the Modified
Licensed Products in Canada.
ARTICLE
10
NOTICES
10.1 Addresses of
Service. Any
notice, request, demand, consent or other communication provided or permitted
hereunder shall be in writing and given by personal delivery, delivered by
courier, transmitted by facsimile, or sent by first
15
Page
16
class
mail, postage prepaid, return receipt requested, addressed to the Partner for
which it is intended at the forwarding addresses:
(a)
|
Glaxo:
|
0000
Xxxxxxxxxxx Xxxx
Xxxxx
Xxxxxxxxxxx,
Xxxxxxx
X0X 0XX
Attention: The
President
Fax: 000-000-0000
(b)
|
BioChem:
|
000
Xxxxxx-Xxxxxxxx Xxxxxxxxx
Xxxx0,
Xxxxxx
X0X
0X0
Attention: The
President
Fax: 000-000-0000
10.2 Change of Address for
Service. Any
Partner may change its address for purposes of transmittal or receipt of any
communication by giving written notice of such change to the other Partner in
the manner prescribed in section 10.1 hereof.
10.3 Deemed
Receipt. Any
notice so given shall be deemed to have been received on the date on which it
was delivered if given by personal delivery or courier or transmitted by
facsimile, or, if mailed, on the fifth (5th) Business Day following the mailing
thereof.
10.4 Postal
Interruption. In the
event of any postal interruption occurring during the Term, any notice, request,
demand, consent or other communication provided or permitted hereunder shall be
given by personal delivery, courier or facsimile.
ARTICLE
11
INDEMNIFICATION AND
SURVIVAL
11.1 BioChem
Indemnity. BioChem
hereby agrees to indemnify and to hold the Partnership and Glaxo harmless from,
against and in respect of, and shall on demand reimburse the Partnership and/or
Glaxo for and shall have no recourse against the Partnership or Glaxo with
respect to, any and all loss, expense, liability or damages suffered or incurred
by the Partnership or Glaxo by reason of
16
Page
17
any
nonfulfillment of any covenant or agreement by BioChem contained herein or
contained in any agreement between the Partnership and BioChem (or any affiliate
of BioChem).
11.2 Glaxo
Indemnity. Glaxo
hereby agrees to indemnify and to hold the Partnership and BioChem harmless
from, against and in respect of, and shall on demand reimburse the Partnership
and/or BioChem for and shall have no recourse against the Partnership or BioChem
with respect to, any and all loss, expense, liability or damages suffered or
incurred by the Partnership or BioChem by reason of any nonfulfillment of any
covenant or agreement by Glaxo contained herein or contained in any agreement
between the Partnership and Glaxo (or any affiliate of Glaxo).
11.3 Extent of
Indemnification. All
indemnifications under this Article 11 shall include the costs of any and all
actions, suits, proceedings, claims, demands, assessments, judgments, costs and
expenses, including, without limitation, legal fees and expenses, incident to
any of the foregoing or incurred in investigating or attempting to avoid the
same or to oppose the imposition thereof, or in enforcing this
indemnity.
11.4 Claim. Each of
Glaxo and BioChem agree that within ten (10) Business Days after it becomes
aware of a right to claim indemnification pursuant to Article 11, the party
asserting such a claim (the “Indemnitee”) shall notify the other party (the
“Indemnitor”) of any claim or demand which the Indemnitee has determined has
given or could give rise to a right of indemnity under this Agreement. If such
claim or demand relates to a claim or demand asserted by a third party against
the Indemnitee (a “Third Party Claim”), the Indemnitor shall have the right to
defend the same at its own cost and expense with counsel of its own selection,
provided that (i) the Indemnitee shall at all times have the right to fully
participate in the defense at its own expense; (ii) the Third Party Claim seeks
only monetary damages and does not seek any injunctive or other relief against
the Indemnitee; (iii) the Indemnitor unconditionally acknowledges in writing its
obligation to indemnify and bold the Indemnitee harmless with respect to the
Third Party Claim; (iv) counsel chosen by the Indemnitor is satisfactory to the
Indemnitee, acting reasonably; and (v) the Indemnitor shall have deposited in
trust with the Indemnitee’s legal counsel either an amount sufficient to secure
the Indemnitor’s potential indemnity liability in the full amount of the
indemnification due with respect to the Third Party Claim, inclusive of
reasonably estimated interest and costs or a letter of credit, surety bond or
similar security in form and substance reasonably satisfactory to the Indemnitee
in an amount sufficient to satisfy the said potential indemnity liability and
shall have executed a letter of instruction in form and substance acceptable to
the Indemnitee acting reasonably, instructing such legal counsel to apply the
amounts held by it or to realize on the letter of credit, surety bond or similar
security held by it in
17
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18
satisfaction
of any judgment rendered against the Indemnitee in connection with such Third
Party Claim.
11.5 Failure to
Defend. If the
Indemnitor shall, within a reasonable time after notice of a Third Party Claim,
fail to defend a Third Party Claim or shall fail to comply at all times with
this Article 11, the Indemnitee shall have the right, but not the obligation, to
undertake the defense of and to compromise or settle the Third Party Claim on
behalf; for the account and at the risk and expense of the
Indemnitor.
11.6 Defence. In the
event the Indemnitor defends a Third Party Claim, it will not be permitted to
control the settlement of the claim, unless (i) the terms of the settlement
require only the payment of money and do not require the Indemnitee to admit any
wrongdoing or take or refrain from taking any action; (ii) the full amount of
the settlement is paid by the Indemnitor; (iii) the Indemnitee receives, as part
of the settlement, a legally binding and enforceable and unconditional release,
which is in form and substance satisfactory to the Indemnitee, acting
reasonably; and (iv) the Third Party Claim and any claim or liability of the
Indemnitee with respect to the claim is being fully satisfied because of the
settlement and the Indemnitee is being released from any and all obligations or
liabilities it may have with respect to the Third Party Claim.
11.7 Set-off. Without
prejudice to the other rights, recourses and remedies of the Indemnitee in order
to recover any amounts payable to it by the Indemnitor hereunder, the Indemnitee
may, at its option, set-off and compensate any amounts payable by it to the
Indemnitor under any provision of this Agreement or any other contract between
the Indemnitor and the Indemnitee against any amounts payable to it by the
Indemnitor, and any amount thus set-off or compensated shall be deemed to have
been paid by the Indemnitee to the Indemnitor.
11.8 Interest. Any
amount payable by the Indemnitor pursuant to this Article 11 shall bear interest
at an annual percentage rate of interest equal to the sum of the Prime Rate plus
one percent (1%) per annum, calculated daily in arrears from the date the
Indemnitee incurs such liability, loss, expense or damage, provided that in no
case shall such interest rate exceed the applicable maximum legal interest
rate.
11.9 Decisions. When the
Partnership is an Indemnitee pursuant to this Article 11, Glaxo shall make all
decisions on behalf of the Partnership if the indemnification is pursuant to
section 11.1 and BioChem shall make all decisions on behalf of the Partnership
if indemnification is pursuant to section 11.2.
18
Page
19
ARTICLE
12
GENERAL
PROVISIONS
12.1 Extension of
Meaning. Unless
the context or subject matter otherwise requires, words importing the singular
number include plural and vice versa; references herein to any contract shall be
deemed to include references to such contract as varied or replaced from time to
time; and references herein to any law shall be deemed to include references to
such law as re-enacted, amended or extended from time to time.
12.2 “Herein”,
etc. In this
Agreement the expressions “herein”, “hereof”, “hereunder”, “hereto”,
“hereinafter” and similar expressions refer to this Agreement and not to any
particular Article, section, paragraph or other portion of this
Agreement.
12.3 Headings of Articles and
Sections. The
titles to the Articles and the sections of this Agreement are inserted herein
solely for convenience; are not part of this Agreement; do not in any way limit
or amplify the terms of the Agreement; and shall not be used as a means of
interpreting the provisions of this Agreement.
12.4 Partial
Invalidity. If any
of the provisions contained in this Agreement shall be declared invalid, illegal
or unenforceable by a court or other authority of competent jurisdiction, then
this Agreement shall continue in force with respect to the enforceable
provisions and all rights and remedies accrued under the enforceable provisions
shall survive any such declaration, and any non-enforceable provision shall, to
the extent permitted by law, be replaced by a provision which being valid, comes
closest to the intention underlying the invalid, illegal or unenforceable
provision.
12.5 Entire
Agreement. This
Agreement together with the Master Licence Agreement, the marketing and licence
agreement between the Partnership and BioChem dated as of January 1, 1996, and
the marketing and services agreement between the Partnership and Glaxo dated as
of January 1, 1996 contain the entire agreement with respect to the subject
matter herein as of the date of this Agreement and supersede all prior
agreements, understandings and negotiations, whether oral or written, of the
Partners with respect to the subject matter of this Agreement. There
are no representations, warranties or conditions of either of the Partners with
respect to the subject matter of this Agreement except as are specifically set
forth herein.
12.6 Governing
Law. This
Agreement shall be governed by the laws of the Province of Ontario and the law
of Canada applicable therein. Each party
19
Page
20
irrevocably
attorns to the non-exclusive jurisdiction of the Courts of Ontario in connection
with the interpretation and enforcement of this Agreement.
12.7 Waiver. No
provision of this Agreement shall be deemed waived and no breach excused unless
such waiver or consent excusing the breach shall be in writing and signed by the
Partner to be charged with such waiver or consent. A waiver by a
Partner of any provision of this Agreement shall not be construed as a wavier of
any further breach of the same or any other provision of this
Agreement
12.8 Amendments. No
amendment, modification or rescission of this Agreement shall be effective
unless set forth in writing signed by a duly authorized representative of each
Partner.
12.9 Enurement. The
terms and conditions contained in this Agreement shall bind the Partners and
their respective successors and permitted assigns from and after the Effective
Date of this Agreement
12.10 English
Language. The
parties hereto have expressly requested that this Agreement and all related
documents and notices be drafted in the English language. Les parties aux
présentes ont exigé, de façon expresse, que le présent contrat de même que tous
les documents et avis qui s’y rattachent soient rédigés en langue
anglaise.
IN WITNESS
WHEREOF the parties hereto have duly executed this Agreement.
GLAXO
WELLCOME INC.
|
|||
Per:
|
|||
Authorized
Officer
|
|||
20
Page
21
BIOCHEM
PHARMA INC.
|
|||
Per:
|
|||
Authorized
Officer
|
|||
Per:
|
|||
Authorized
Officer
|
|||
21
SCHEDULE “A” - LICENSED
PATENTS
DOCKET
NUMBER
|
COUNTRY
|
STATUS
|
APP.
NUMBER
|
APP.
DATE
|
CURRENT
OWNER
|
FILE
NUMBER
(GLAXO)
|
*****
|
*****
|
Filed
|
*****
|
*****
|
BIOCHEM
PHARMA INC.
|
*****
|
*****
|
*****
|
Filed
|
*****
|
*****
|
BIOCHEM
PHARMA INC.
|
*****
|
*****
|
*****
|
Filed
|
*****
|
*****
|
BIOCHEM
PHARMA INC.
|
*****
|
SCHEDULE
4
TABLE OF
CONCORDANCE
Original
Agreement
|
This
Agreement
|
31
January 1990
Master
Licence Agreement
|
20
November 1995
Revised
and Restated Master Licence Agreement
|
$
Schedule 1 “Proposed Development Plan”
|
deleted
|
$
Schedule 2 “Licensed Product”
|
Schedule
1 “Residual Product”
|
$
Schedule 3 “Licensed Patents”
|
Schedule
2 “Licensed Patents”
|
$
Schedule 4 “Joint Venture Formation Agreement”
|
Schedule
3 “Partnership Agreement”
|
$
Schedule 5 “Outline of Arrangements for Manufacture, Supply and
Distribution” (Canada)
|
deleted
|
$
Schedule 6 “Outline of Arrangements for Distribution and Supply
Agreement” (USA)
|
deleted
|
Sponsored
Research Agreement, as amended
|
concluded
|
Addendum
to Master Licence Agreement
|
deleted
|
24
January 1991
Revised
Joint Venture Formation Agreement
|
deleted
|
$
Schedule 1 “Articles of Incorporation”
|
joint
venture corporation to be dissolved
|
$
Schedule 2 “‘Unanimous Shareholders Agreement”
|
deleted
|
$
Schedule 3 “Joint Venture Operation Agreement”
|
Partnership
Agreement
|
$
Schedule 4 “Rights Agreement”
|
deleted
|
$
Schedule 5 “Addendum to Master
|
deleted
|
$
Schedule 5 “Addendum to Master Licence Agreement”
|
deleted
|
Subscription
Agreement
|
concluded
|
Shareholders
Agreement
|
terminated
|
1
August 1991
Collaborative
Research Agreement, as amended
|
concluded
|
Schedule
4 Table of Concordance
|
SCHEDULE
5
TO
BIOCHEM:
BioChem
Pharma Inc.
000
Xxxxxx-Xxxxxxxx Xxxx.
Xxxxx,
Xxxxxx X0X 0X0
Xxxxxx
Attn:
President
Fax: (000)
000-0000
TO
GROUP:
Glaxo
Group Limited
Xxxxxxxxx
Xxxxx
Xxxxxxxx
Xxxxxx
X0X 0XX
Xxxxxxx
Attn:
Company Secretary
Fax:
000-00-0-00-000-0000
TO GLAXO
WELLCOME INC. (GWUS)
Glaxo
Wellcome Inc.
Five Xxxxx
Xxxxx
Xxxxxxxx
Xxxxxxxx Xxxx
Xxxxx
Xxxxxxxx 00000 XXX
Attn:
General Counsel
Fax: (000)
000-0000
TO GLAXO
WELLCOME INC. (GWC)
Glaxo
Wellcome Inc.
0000
Xxxxxxxxxxx Xxxx Xxxxx
Xxxxxxxxxxx,
Xxxxxxx
X0X 0X0
Xxxxxx
Attn:
President
Fax: (000)
000-0000
TANAUD
HOLDINGS (BARBADOS) LIMITED
Chancery
Xxxxxxxx
Xxxxxxxx
Xxxxx, Xxxx Xxxxxx
Xxxxxxxxxx,
Xxxxxxxx
Attn: Xx.
Xxxxxx Xxxxxxxxxx
Fax: (000)
000-0000
TO TANAUD
INTERNATIONAL B.V. (TIB)
Xxxxxxxxxxx
Xxxxxxxxxxx 000 X
0000 XX
Xxxxxxxxx
Xxx
Xxxxxxxxxxx
Attn:
Managing Director
Fax:
00-00-000-0000
TO TANAUD
LLC. (TLLC)
Ernst
& Young Building
Xxxx Xxxx,
Bay Street
Bridgetown,
Barbados
Attn:
Managing Director
Fax: (000)
000-0000