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[ * ] = Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.
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(1) BTG International
Limited
(2) Onyx Pharmaceuticals
Inc.
Development and Licence
Agreement
THIS
AGREEMENT is made the 6 th day of November 2008
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(1)
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BTG International Limited
a company incorporated
under the laws of England with company registration number 02664412
and whose registered office is at 10 Fleet Place, Limeburner Lane,
London EC4M 7SB (“BTG”); and
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(2)
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Onyx Pharmaceuticals Inc.
a corporation
incorporated under the laws of the State of Delaware whose
principal office is at 2100 Powell Street, Emeryville, CA 94608
(“Onyx”).
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(A)
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BTG
has acquired and commenced the development of a technology
comprising a product known as BGC-0945 which, subject to further
development, is intended to be used in the field of
oncology.
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(B)
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Onyx is in the business of
developing and commercializing anticancer therapies.
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(C)
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BTG
is willing to grant to Onyx, and Onyx wishes to receive, a
worldwide, sub-licensable, royalty-bearing, licence to develop,
make, have made, use, import, sell, distribute, have sold and offer
for sale products in accordance with and subject to the provisions
set out in this Agreement.
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THE PARTIES
AGREE AS FOLLOWS:-
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1.
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DEFINITIONS
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In
this Agreement the following words and expressions shall have the
following meanings:-
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“Affiliate”
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any entity that
directly or indirectly controls, is controlled by, or is under
common control with another entity, for so long as such control
exists. In the case of companies and corporations
“control” and “controlled” means beneficial
ownership of more than fifty percent of the voting stock, shares,
interest or equity in an entity. In the case of any other legal
entity, “control” and “controlled” shall
exist through the ability to directly or indirectly control the
management and/or business of the legal entity;
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“BGC-0945”
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[ * ] (the
structure of which is shown in Schedule 6) or any salts,
esters, racemates, stereoisomers, crystalline polymorphs, hydrates,
solvates, or other acids thereof.
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“Combination Product”
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shall have the
meaning given to it in Clause 1.33;
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“Commencement Date”
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the date first
above written;
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“Commercially Reasonable
Endeavours”
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[ *
];
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“Confidential Material”
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shall have the
meaning given to it in Clauses 11.1 and 11.2;
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[ *
]
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= Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.
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1
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“Damages”
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shall have the
meaning given to it in Clause 16.6;
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“Deductions”
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shall have the
meaning given to it in Clause 1.33;
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“Detailed
Development Plan”
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the detailed
development plan to be prepared by Onyx pursuant to Clause
9.3;
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“Disclosing Party”
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shall have the
meaning given to it in Clause 11.1;
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“EU”
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member states
of the European Union as it is constituted from time to
time;
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“FDA”
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United States
Food and Drug Administration, or any successor entity
thereto;
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“ICR”
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shall have the
meaning given to it in Clause 11.9;
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“IND”
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investigational
new drug application as defined by FDA;
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“Infringement”
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any
infringement of any of the Licensed Rights;
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“Infringer”
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a third party
that commits, or is alleged to have committed, an
Infringement;
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“International Accounting
Standards”
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the
international accounting standards within the meaning of Regulation
(EC) No. 1606/2002 of the European Parliament and of the
Council of 19 July 2002, adopted from time to time by the
European Commission in accordance with the Regulation;
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“Licensed
Know-How”
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the know-how,
data, trade secrets, manufacturing processes and proprietary
information that is owned or controlled by BTG as of the
Commencement Date as set out in Schedule 2;
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“Licensed
Patents”
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means:-
(a) the Patent Applications;
(b) any patents granted in respect of the Patent
Applications;
(c) the granted patents listed in Schedule 1; and
(d) in relation to any patents falling within (b) or (c)
above, any re-issues, renewals, re-examinations, extensions,
confirmations, continuations, continuations-in-part or divisionals
thereof, and any Patent Term Extensions granted in connection with
such patents; and
(e) any foreign counterparts of the foregoing patents and
patent applications.
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“Licensed
Products”
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BGC-0945 and
any other product, the research, development, manufacture, import,
marketing, use, sale or supply of which would (a) use or
incorporate (or has used or incorporated) any Licensed Know-How; or
(b) but for the Licence, would infringe the Licensed
Patents;
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“Licensed
Rights”
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the Licensed
Patents and the Licensed Know-How;
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“Licensed
Technology”
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the technology
claimed by the Licensed Patents and/or included in the Licensed
Know-How;
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[ *
]
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= Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.
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2
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“Licences”
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the licences
granted under Clause 2.1;
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“Major
European Country”
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the [ *
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“Major
Markets”
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the [ *
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“Materials”
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the quantities
of bulk intermediates, active pharmaceutical ingredients and
formulated Licensed Products, listed in Schedule 3;
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“Materials Payment”
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shall have the
meaning given to it in Clause 5.2;
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“MHRA”
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Medicines and
Healthcare products Regulations Agency (or any successor entity
thereto);
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“Milestone Events”
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the milestone
events set out in Clause 5.3;
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“Milestone Payments”
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the milestone
payments set out in Clause 5.3;
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“NDA”
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shall mean a
new drug application (as more fully defined in 21 Code of Federal
Regulations section 314.5 et seq);
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“Net
Receipts”
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(a) all
royalties, profit shares or other amounts received by Onyx or any
Affiliate of Onyx from a Sub-licensee or its Affiliates (other than
an Affiliate of Onyx), or any subsequent sub-licensees thereof,
relating to sales of Licensed Products (it being understood that
this definition excludes [ * ], but includes [ * ]) and
(b) solely in the event that the commercialization of the
Licensed Products in [ * ] is being carried out or is to be carried
out by a Non-Affiliate Sub-licensee, any milestones or other
payments received by Onyx or any Affiliate of Onyx from such
Sub-licensee as a result of (i) the [ * ] or (ii) the [ *
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“Net
Sales Value”
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the amount
billed or invoiced by Onyx Suppliers to third parties in respect of
supplies of the Licensed Products (in fully formulated, final form
packed for ultimate consumer use) less the following items as
indicated on the relevant invoice (but only to the extent relating
to the Licensed Product and actually paid or allowed and not
reimbursed by any third party and provided that no deductions shall
be allowed for any advertising, promotional or sales force
expenses): (i) tariffs, duties, excises and sales taxes,
(ii) costs of delivery, including transportation and insurance
charges, (iii) customary trade or quantity discounts actually
granted, (iv) amounts actually repaid or credited by reason of
rejections, defects, recalls or returns or because of adjustments,
billing errors, or trial prescriptions, (vi) amounts that are
recorded in the sellers audited accounts as written off as bad
debts, uncollectible in accordance with the applicable
seller’s accounting policies for the general provision of
doubtful debts, as consistently applied and as allowed by United
States Generally Accepted Accounting Principles or International
Accounting Standards (as the case may be), (vii)
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[ *
]
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= Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.
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3
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allowances or
credits to customers on account of price reductions affecting the
Licensed Products, and (viii) rebates and discounts actually
paid or credited to any governmental agency (or branch of
government) (the “Deductions”); provided that
where:
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(a) the
Licensed Products are sold other than in an arm’s-length
sale; or
(b) the consideration for the Licensed Product includes any
non-cash element other than customary rights that are typically
granted to customers in contracts with cash customers (for the
avoidance of doubt such customary rights shall not include equity,
stock or any other form of securities or any loan arrangement
otherwise than on normal commercial terms); or
(c) the Licensed Product is transferred in any manner other
than an invoiced order,
the Net Sales Value applicable to such transaction shall be deemed
to be the amount billed or invoiced by Onyx Suppliers to
independent third parties in respect of supplies of the Licensed
Products (in fully formulated, final form packed for ultimate
consumer use) that would have been billed or invoiced for that
Licensed Product in the country where the transaction was effective
had (a), (b) and/or (c) not been the case, less the
Deductions (where such Deductions relate to the Licensed Product
and are actually paid or allowed and not reimbursed by any third
party and provided that no Deductions shall be allowed for any
advertising, promotional or sales force expenses) that would have
been applicable for that Licensed Product in the country where the
transaction was effective had (a), (b) and/or (c) not
been the case. Such hypothetical Net Sales Value shall be agreed by
the parties acting in good faith or, failing such agreement, as
determined by a reputable independent auditor appointed by
agreement between the parties (or failing such agreement, the
Chairman for the time being of the Institute of Chartered
Accountants of England and Wales), with the decision of such
auditor being final and binding on the parties and with the auditor
acting as an expert and not an arbitrator. If the price determined
by the auditor is equal to or lower than that proposed by Onyx then
BTG shall be responsible for the costs of the appointment of the
auditor. If the price determined by the auditor is greater than
that proposed by Onyx then Onyx shall be responsible for the costs
of such appointment;
provided, further that if a Licensed Product is sold in the form of
a combination product containing both a Licensed Product and one or
more active pharmaceutical ingredients or devices that are not
Licensed Products (for the purpose of this Agreement, a
“Combination Product”), the Net Sales Value of such
Licensed Product for the purpose of calculating royalties owed by
Onyx under this Agreement for sales of such Licensed Product, shall
be determined as follows: first, Onyx shall determine the
actual
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[ *
]
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= Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.
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4
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Net Sales Value
of such Combination Product (using the above provisions) and then
such amount shall be multiplied by the fraction A/(A+B), where A is
the invoice price of the Licensed Product, if sold separately, and
B is the total invoice price of any other active pharmaceutical
ingredient or device in the combination if sold separately. If, the
other active pharmaceutical ingredient or device in the combination
are not sold separately, Net Sales Value of the Licensed Product in
question shall be calculated by multiplying actual Net Sales Value
of such Combination Product (calculated using the above provisions)
by a fraction A/C where A is the invoice price of the Licensed
Product if sold separately, and C is the invoice price of the
Combination Product where the maximum value of the fraction A/C
equals one (1). If, neither the Licensed Product nor the other
active pharmaceutical ingredient or device in the Combination
Product is sold separately, the adjustment to Net Sales Value shall
be determined by the parties in good faith to reasonably reflect
the fair value of the contribution of the Licensed Product in the
Combination Product to the total market value of such
product;
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Non-Affiliate
Sublicensee
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a Sublicensee
that is not also an Affiliate of Onyx;
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“Onyx
Suppliers”
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Onyx, its
Affiliates, its Sub-licensees and the Affiliates of the
Sub-licensees;
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“Outline
Development Plan”
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the outline
development plan relating to the development and commercialisation
of Licensed Products as agreed between the parties and set out in
Schedule 5;
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“Patent
Applications”
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the patent
applications listed in Schedule 1 and any continuation
applications, continuation-in-part applications, divisional
applications, national or international patent applications
anywhere in the world in each case that claim priority solely from
the patent applications listed in Schedule 1 and/or any of
their priority filings;
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“Patent
Term Extension”
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any patent term
extensions, including extensions granted under the US Drug Price
Competition and Patent Term Restoration Act 1984 and the EC
Supplementary Protection Certificate Regulation (Council Regulation
(EEC) No. 1768/92) and any legislation, amending, replacing or
implementing the foregoing;
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“Personnel”
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officers,
employees, consultants, agents, representatives, contractors and
advisers;
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“Phase I
Clinical Trial
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“a human
clinical trial, the principal purpose of which is to determine the
metabolic and pharmacologic actions of a drug and its safety, the
side effects associated with increasing doses and, if possible, to
gain early evidence of its effectiveness;
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“Phase II
Clinical Trial”
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a human
clinical trial, the principal purpose of which is to evaluate the
effectiveness of a drug for a particular indication in patients
with a disease and to determine the common short-term side effects
and risks associated with the drug;
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[ *
]
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= Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.
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5
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“Phase
III Clinical Trial”
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an expanded
controlled or uncontrolled human clinical trial of a drug in a
randomized study (with endpoints agreed upon by a regulatory body
for Product Approval for example, without limitation, as evidenced
in the minutes of an end of Phase II Clinical meeting with a
competent regulatory authority in the United States of America or
the EU) which is intended to gather the additional information
about effectiveness and safety that is needed to evaluate the
overall benefit-risk relationship of such drug and to provide an
adequate basis for physician labelling;
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“Product
Approval”
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in relation to
a country, the grant of all governmental, regulatory and pricing
approvals required to sell a Licensed Product in that
country;
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“Quarter”
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the quarterly
periods in each Year of the Term ending 31 March, 30 June, 30
September and 31 December with the exception of the first Quarter
of this Agreement, which shall be the period of time from the
Commencement Date to 31 December 2008;
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“Reasonable Revisions”
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such revisions
by Onyx as may be reasonably necessary (in good faith and having
regard to Onyx’s obligations in Clause 9) after the
Commencement Date to adjust development of Licensed Products in
response to changed external circumstances comprising material [ *
] problems arising regarding the Licensed Product but not [ *
];
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“Receiving Party”
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shall have the
meaning given to it in Clause 11.1;
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“Revocation Proceedings”
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“any
proceedings where the validity of any of the Licensed Patents is at
issue including opposition proceedings in respect of European
patents and interference proceedings in respect of US
patents;
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“Signing
Fee”
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shall have the
meaning given to it in Clause 5.1
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“Sub-licence Agreement”
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any agreement
between Onyx and a Sub-licensee relating to this Agreement or any
of the Licensed Rights;
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“Sub-licensee”
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a third party
(including an Affiliate of Onyx) to whom Onyx and/or any of its
Affiliates has sub-licensed, sub-contracted or otherwise
transferred any of Onyx’s rights and/or obligations under
this Agreement including, a third party with whom Onyx and/or any
of its Affiliates has agreed not to assert the Licensed Rights
and/or has otherwise waived the Licensed Rights (unless such waiver
or non-assert has been given with the prior written consent of
BTG), it being understood that a failure to bring or maintain an
infringement suit against an alleged infringer shall not, by
itself, constitute a waiver for the purpose of this definition
unless Onyx and/or any of its Affiliates are receiving
consideration of any form from, or otherwise supplying a Licensed
Product to, the alleged infringer or its Affiliates;
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“Term”
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shall have the
meaning given to it in Clause 18.1;
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[ *
]
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= Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.
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6
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“Termination Milestone”
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Shall have the
meaning given to it in Clause 19.3;
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“Third
Party Claims”
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shall have the
meaning given to it in Clause 5.11;
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“Third
Party Royalty”
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shall have the
meaning given to it in Clause 5.11;
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“United
States Generally Accepted Accounting Standards”
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means the
generally accepted accounting principles as established by the
United States of America Financial Accounting Standards Board from
time to time;
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“Valid
Claim”
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an issued claim
of any unexpired patent or claim of any pending patent application,
which has not been held unenforceable, unpatentable or invalid by a
court or governmental body of competent jurisdiction, unappealable
through disclaimer or otherwise, and which has not been lost
through an interference proceeding or abandoned; provided, however,
that if a claim of a pending patent application has been pending
for more than [ * ] years from the Commencement Date or, if applied
for after the Commencement Date, has been pending for more than [ *
] years from its application date, such claim will not constitute a
Valid Claim for the purposes of this Agreement from the end of that
[ * ] period (as applicable) unless and until such claim issues and
otherwise satisfies the above requirements at which time the claim
shall be deemed a Valid Claim [ * ] for the purposes of, inter
alia , calculating any royalty obligation from Onyx to BTG
(subject to Clause 5.7); and
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“Year”
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a calendar
year;
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2.1.
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With effect from the Commencement
Date and subject to the provisions of this Agreement, BTG grants to
Onyx, an exclusive, worldwide, sub-licensable, royalty-bearing,
licence under the Licensed Rights to develop, make, have made, use,
import, sell, distribute, have sold and offer for sale Licensed
Products for all applications and for all uses.
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2.2.
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Promptly following the Commencement
Date (but in any event no later than thirty (30) days
thereafter), BTG shall transfer to Onyx all Licensed Know-How, to
the extent such Licensed Know-How is not already in Onyx’s
possession. All costs and expenses of any such transfer by BTG
shall be borne by BTG. Subject to Clause 19.2.2 all media supplied
by BTG to Onyx in which Licensed Know-How is recorded shall be
thereafter owned by Onyx.
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2.3.
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If,
following the Commencement Date, BTG discovers know-how or
information that was in the possession of, and owned or controlled
by, BTG prior to the Commencement Date that is necessary or (in [ *
]’s opinion) reasonably useful for the development,
manufacture, or commercialization of BGC-0945 or any other molecule
claimed in the Licensed Patents and that [ * ] from BTG’s
development of BGC-0945 prior to the Commencement Date, which is
not set out in Schedule 2, BTG shall, upon discovery, subject
to [ * ], provide such know-how or information to Onyx. Such
know-how or information shall become, for the purposes of this
Agreement, Licensed Know-How provided that [ * ].
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[ *
]
|
|
= Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.
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7
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2.4.
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If,
following the Commencement Date, BTG discovers patent(s) or patent
application(s) that were in the possession of, and owned or
controlled by, BTG prior to the Commencement Date that are
necessary or (in [ * ]’s opinion) reasonably useful for the
development, manufacture, or commercialization of BGC-0945 or any
other molecule claimed in the Licensed Patents (as defined on the
Commencement Date without regard to the rest of this
Section 2.4) and that [ * ] from BTG’s development of
BGC-0945 prior to the Commencement Date, which is not set out in
Schedule 1, BTG shall, upon discovery, subject to [ * ],
provide such patent(s) and/or patent application(s) to Onyx. Such
patent(s) and/or patent application(s) shall become, for the
purposes of this Agreement, Licensed Patents (and shall be deemed
to be included on Schedule 1), provided that [ * ].
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2.5.
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In
no event shall Onyx be responsible for any payments owed by BTG or
its Affiliates under any agreements between a third party and BTG
or its Affiliates related to the Licensed Products or Licensed
Technology, as a result of the grant of the Licences or the
exploitation of the Licences by Onyx, its Affiliates, or its
Sub-licensees.
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2.6.
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In
no event shall BTG be responsible for any payments owed by Onyx or
its Sub-licensees or their respective Affiliates under any
agreements between a third party and Onyx or its Sub-licensees or
their respective Affiliates related to the Licensed Products or
Licensed Technology, as a result of the grant of the Licenses or
the exploitation of the Licenses by Onyx, its Affiliates, or its
Sub-licensees or their Affiliates. For the avoidance of doubt, this
Clause 2.6 shall not affect the operation of the royalty reduction
provision in Clause 5.11.
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3.
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DURATION OF THE
LICENCES
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3.1
|
|
Unless terminated earlier in
accordance with Clause 18 of this Agreement, the Licences shall
commence on the Commencement Date and shall automatically expire on
a country by country basis on the last to occur of the
following:-
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3.1.1
|
|
the
date on which no Valid Claim of a Licensed Patent remains in force
in the country concerned; or
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3.1.2
|
|
ten
(10) years from the date of the first commercial sale of the
relevant Licensed Product in the country concerned.
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3.2
|
|
Following expiry of the Licences in
a country, Onyx’s obligation to pay further royalties
pursuant to Clause 5.5 and 5.6 in respect of Net Sales Value of
Licensed Products in such country (unless the Licensed Products
sold in such country are manufactured in a country where a Valid
Claim subsists) shall terminate and Onyx shall have a fully paid
up, royalty-free (subject to Onyx’s obligation to pay
royalties on Net Sales Value of Licensed Products sold in such
country but manufactured in a country where a Valid Claim
subsists), perpetual, exclusive licence under the Licensed Know-How
to make, have made, use, import, promote, distribute, sell, offer
for sale and otherwise exploit the Licensed Products in that
country.
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4.
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SUBLICENSING AND
SUBCONTRACTING
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4.1
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Onyx may sub-licence and/or
subcontract its rights under this Agreement provided it complies
with this Clause 4.
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[*]
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=
|
Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.
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8
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4.2
|
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Onyx shall enter into a written
agreement with each Sub-licensee (provided that this obligation to
enter into a written agreement shall not apply where, and for so
long as, the Sub-licensee is an Affiliate) and shall ensure
that:-
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4.2.1
|
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the
provisions of the Sub-licence Agreement are entirely consistent
with the provisions of this Agreement;
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4.2.2
|
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the
Sub-licence Agreement is [ * ] and [ * ] the [ * ] from [ * ] the [
* ] without the prior written consent of BTG, not to be
unreasonably withheld;
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4.2.3
|
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the
Sub-licence Agreement prohibits the Sub-licensee and its Affiliates
from [ * ] or otherwise [ * ] in each case without the prior
written consent of BTG, not to be unreasonably withheld;
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4.2.4
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the
Sub-licence Agreement sets out all the terms agreed between the
parties including, in particular, all terms as to
remuneration;
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4.2.5
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the
Sub-licence Agreement imposes obligations of confidentiality on the
Sub-licensee in respect of any Confidential Material disclosed by
BTG and/or its Affiliates which are no less onerous than those set
out in Clause 11;
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4.2.6
|
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the
Sub-licence Agreement shall terminate automatically if
(1) this Agreement expires or is terminated (subject to Clause
4.7) or (2) the Sub-licensee or its Affiliates [ * ] or
otherwise assist any third party to [ * ], the [ * ] of any of the
[ * ] including the [ * ] of any of the [ * ] of the [ *
];
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4.2.7
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the
Sub-licence Agreement imposes an obligation on the Sub-licensee to
(a) keep and provide financial statements and other such
information as is reasonably required to allow Onyx to document and
verify payments required to be made to BTG under this Agreement and
otherwise to comply with all of its obligations under this
Agreement (including, without limitation, the provision of the
royalty statement as set out in Schedule 4), and on
Onyx’s request, (b) allow an independent professional
accountant appointed by Onyx to be given access to and be permitted
to examine and copy the books, accounts and records of the
Sub-licensee (and the Sub-licensee’s Affiliates, to the
extent relevant) upon [ * ] days notice having been given by Onyx
and at all reasonable times on business days for the purpose of
certifying to Onyx that the monies calculated by the Sub-licensee
as being due to Onyx under the relevant Sub-licence Agreement
during any Year and the sale of Licensed Products in any Year were
each correctly calculated, true and accurate; and (c) oblige
the Sub-licensee to make available its Personnel on [ * ] days
advance notice and during normal business working hours, to answer
queries on all accounts, books and records required for the purpose
of the above certification;
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4.2.8
|
|
the
Sub-licence Agreement imposes an obligation on the Sub-licensee to,
on termination of the Sub-licence Agreement (but, for the avoidance
of doubt, excluding any expiration of the Sub-license Agreement
following which the Sub-licensee retains the right to sell and
distribute the Product), transfer to Onyx all Product Approvals for
the Licensed Products that are owned by the applicable Sub-licensee
or its Affiliates as well as all technical information or data
generated by or on behalf of the Sub-licensee or its Affiliates
pursuant to activities conducted under the Sub- license Agreement,
including without limitation, market research so generated to
support the sale and distribution of the Licensed Product;
and
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[*]
|
=
|
Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.
|
9
|
|
4.2.9
|
|
the
Sub-licensee shall be required by the Sub-license Agreement to
include on the packaging of each Licensed Product and in the
information leaflet supplied with each Licensed Product the notice
set out at Clause 10.2 (subject to any limitations imposed by
applicable law).
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4.3
|
|
Onyx shall procure that each
Sub-licensee complies fully at all times with the provisions of its
Sub-licence Agreement.
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|
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4.4
|
|
Any
acts and omissions of a Sub-licensee that, if committed by Onyx,
would constitute a breach of any of the provisions of this
Agreement, shall be deemed to be a breach of this Agreement by
Onyx.
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|
|
|
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|
4.5
|
|
Onyx shall promptly notify BTG of
the details of any material breach of a Sub-licensee of which it
becomes aware to the extent that such material breach would
reasonably be expected to cause Onyx to be in breach of its
obligations under this Agreement.
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4.6
|
|
Onyx shall provide BTG with a true
and complete copy of any Sub-licence Agreement promptly following
its execution; provided, however, that Onyx may redact any portions
of such Sub-licence Agreement that are confidential or proprietary
(other than any portions relating to payments or other
consideration payable by Sub-licensees with respect to the Licensed
Products and any other provisions that are necessary for BTG to
verify Onyx’s compliance with the terms of this
Agreement).
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4.7
|
|
At
Onyx’s request and on a case-by-case basis, unless
termination is due to acts or omissions of a Sub-licensee or the
relevant Sub-licensee is otherwise in breach of the terms of the
Sub-licence, BTG shall in good faith consider amending this
Agreement to allow the rights granted by Onyx to a particular
Sub-licensee to continue (i.e., as a direct licence from BTG)
following termination of this Agreement.
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5.
|
|
PAYMENTS
|
|
5.1
|
|
Onyx shall pay to BTG on the
Commencement Date a one-time, non-refundable signing fee of [ * ]
(the “Signing Fee”).
|
Payment
for the Materials
|
5.2
|
|
Onyx shall pay to BTG on the
Commencement Date a non-refundable payment of [ * ] in respect of
the transfer of the Materials (the “Materials
Payment”).
|
|
5.3
|
|
Onyx shall pay to BTG the following
non-refundable Milestone Payments on the attainment of the
corresponding Milestone Event by an Onyx Supplier:
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|
|
|
|
[*]
|
=
|
Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.
|
10
|
|
|
|
|
Milestone
Event
|
|
Milestone Payments
|
Development
Milestone Event
|
|
Development
Milestone Payment
|
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|
US$[ *
]
|
|
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|
US$[ *
]
|
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|
US$[ *
]
|
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|
US$[ *
]
|
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|
US$[ *
]
|
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|
US$[ *
]
|
|
|
|
US$[ *
]
|
|
|
|
US$[ *
]
|
|
|
|
US$[ *
]
|
|
|
|
US$[ *
]
|
|
|
|
Sales
Milestone Payment
|
|
|
|
US$[ *
]
|
|
|
|
US$[ *
]
|
|
|
|
US$[ *
]
|
|
|
|
US$[ *
]
|
|
5.4
|
|
No
Milestone Payments shall be payable more than once and all
Milestone Payments are non-refundable in any
circumstances.
|
Sales by
Onyx and its Affiliates
|
5.5
|
|
Onyx shall pay to BTG a royalty at
the applicable incremental rate(s) set out below on the Net Sales
Value of all Licensed Products sold by Onyx and/or its Affiliates
and manufactured or sold in a country where there exists, at the
time of manufacture or sale, one or more Valid Claims of the
Licensed Patents that, but for the Licence, would be infringed by
such manufacture or sale:
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|
|
|
|
|
|
|
|
|
Portion of
Cumulative Worldwide Net Sales Value
|
|
|
|
Tier
|
|
of Licensed
Products Supplied During the Year
|
|
Royalty
Rate
|
|
|
|
US$[ *
]
|
|
[ *
]%
|
|
|
|
US$[ *
]
|
|
[ *
]%
|
|
|
|
US$[ * ] and
over
|
|
[ *
]%
|
|
|
|
For
the avoidance of doubt, each of the royalty rates set forth in this
Clause 5.5 shall apply only to that portion of the Net Sales Value
during a Year that falls within the applicable range for such
royalty rate. For example, [ * ].
|
|
|
|
|
|
5.6
|
|
Onyx shall pay to BTG a royalty at
the applicable rate set out below on the Net Sales Value of all
Licensed Products sold by Onyx and/or its Affiliates where such
Licensed Product was manufactured in a country and sold in a
country where, at the time of manufacture and at the time of sale,
no Valid Claim of a Licensed Patent exists in such
country/countries that, but for the Licence, would be infringed by
such manufacture or sale (as applicable), provided that at least
one of the following is true:
|
|
|
|
|
[*]
|
=
|
Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.
|
11
|
|
5.6.1
|
|
had
the Licensed Product concerned been [ * ] (as applicable) in [ * ]
in which a Valid Claim of a Licensed Patent exists that, but for
the Licence, would be infringed by such [ * ] (as applicable), such
[ * ] would have infringed that Valid Claim;
|
|
|
|
|
|
|
|
5.6.2
|
|
had
such Licensed Product concerned been [ * ] (as applicable) [ * ] in
the county/countries in which it was [ * ], such [ * ] would have
infringed a Valid Claim of a Licensed Patent which, but for the
Licence, would have been infringed by such [ * ] (as
applicable);
|
|
|
|
|
|
|
|
5.6.3
|
|
the
Licensed Product is [ * ]; or
|
|
|
|
|
|
|
|
5.6.4
|
|
such Licensed Product [ * ] (or has
[ * ] or [ * ], or the Product Approval for such Licensed Product
was [ * ], in each case [ * ], [ * ].
|
|
|
|
|
|
|
|
|
|
Culmulative
Worldwide Net Sales Value of Licensed
|
|
|
|
Tier
|
|
Products
Supplied During the Year
|
|
Royalty
Rate
|
|
|
|
US$[ *
]
|
|
[ *
]%
|
|
|
|
US$[ *
]
|
|
[ *
]%
|
|
|
|
US$[ * ] and
over
|
|
[ *
]%
|
|
|
|
For
the avoidance of doubt, each of the royalty rates set forth in this
Clause 5.6 shall apply only to that portion of the Net Sales Value
during a Year that falls within the applicable range for such
royalty rate. Additionally, if in a particular Quarter there are
sales of a Licensed Product in a country to which Clause 5.5
applies and sales of a Licensed Product in a country to which
Clause 5.6 applies, then the royalties shall be calculated by
determining the percentage of the total Net Sales Value in such
Quarter to which Clause 5.5 or Clause 5.6 applies and multiplying
that percentage to each royalty tier to determine which portion of
such amount should bear royalties at rates set forth in Clause 5.5
or Clause 5.6, respectively. By way of example, [ * ].
|
|
|
|
|
|
5.7
|
|
[ *
].
|
|
5.8
|
|
Onyx shall pay to BTG whichever is
the greater of (i) [ * ]% of all Net Receipts received by Onyx or
its Affiliates from any Sub-licensee or its Affiliates; or
(ii) a royalty of [ * ]% of the Net Sales Value of all
Licensed Products sold by Non-Affiliate Sub-licensees or their
Affiliates or any subsequent sub-licensee thereof.
|
|
|
|
|
|
5.9
|
|
In
the event that the royalty payment calculated by a Non-Affiliate
Sub-licensee of Onyx or a Sub-licensee of any Affiliate of Onyx, or
any subsequent sub-licensees thereof, as being due to Onyx under
the relevant Sub-licence Agreement during any Year prove, following
verification carried out by Onyx or an independent professional
accountant appointed by
|
|
|
|
|
[*]
|
=
|
Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.
|
12
|
|
|
Onyx for the purpose of calculating
that the monies paid to Onyx were correctly calculated and
accurate, to be inaccurate (and, therefore, the monies paid to BTG
in accordance with Clause 5.8 are inaccurate) Onyx shall either (as
applicable):
|
|
|
5.9.1
|
|
within [ * ] days of the end of the
month in which such verification was carried out, pay to BTG the
balance of the monies due; or
|
|
|
|
|
|
|
|
5.9.2
|
|
within [ * ] days of receipt of
written notification from Onyx that Onyx has paid more than was
due, BTG shall reimburse Onyx for such sum. Such notification shall
include sufficient evidence to enable BTG to verify the accuracy of
such notification.
|
|
5.10
|
|
Onyx’s obligations to pay
royalties in accordance with Clauses 5.5 and 5.6 shall terminate in
accordance with the provisions of Clause 3.2. Onyx’s
obligations to make payments under Clause 5.8 shall terminate at
the end of the Term.
|
Infringement of Third Party
Patents
|
5.11
|
|
If
it is not reasonably possible to sell and/or have sold a Licensed
Product, or to manufacture a Licensed Product for sale, in one or
more countries without infringing one or more Valid Claims of third
party patents that apply to or cover the inventions claimed in the
Licensed Patents in such countries (“Third Party
Claims”) and as a consequence Onyx is required to make and
does make royalty payments or licence fees to a non-Affiliate
independent third party in respect of such one or more Third Party
Claims in order to sell a Licensed Product, or to manufacture a
Licensed Product for sale, in such countries then, subject to the
provisions of Clause 5.12, Onyx may deduct from the royalties that
are otherwise due to BTG as provided in Clause 5.5 and 5.6 in
respect of the Licensed Product that is sold or manufactured (as
the case may be) in the countries covered by the Third Party
Claims, [ * ]% of the royalty payments or license fees paid by Onyx
to Third Parties in respect of that Licensed Product in the
countries covered by the Third Party Claims (“Third Party
Royalty”). For the avoidance of doubt, Onyx may only make
deductions from royalties pursuant to this Clause 5.11 to the
extent that the royalty payments or licence fees made to the third
party concerned relate solely to Third Party Claims applying to or
covering the inventions claimed in the Licensed Patents.
|
|
|
|
|
|
5.12
|
|
In
the event that Onyx is unable to deduct from a particular royalty
payment the full deduction in respect of Third Party Royalties that
is permitted by Section 5.11, the unrealized portion such
deduction will be carried over to subsequent royalty
payments.
|
|
|
|
|
|
5.13
|
|
In
no circumstances shall any provisions of this Agreement (including
Clauses 5.11, 5.12 and the provision in Clause 1.33 setting out the
manner in which Net Sales Value shall be calculated where a
Licensed Product is sold as a Combination Product) operate to
reduce the effective royalty on Net Sales Value payable by Onyx
under Clause 5.5 to less than [ * ]% or under Clause 5.6 to less
than [ * ]%.
|
|
|
|
|
|
5.14
|
|
The
provisions of (a) Clauses 5.11 and 5.12 and the provisions of
(c) Clause 1.33 which sets out the manner in which Net Sales
Value shall be calculated where a Licensed Product is sold as a
Combination Product, cannot both be applied to the same sale of a
Licensed Product.
|
|
|
|
|
[*]
|
=
|
Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.
|
13
|
5.15
|
|
For
the avoidance of doubt, Clause 5.11 and 5.12 shall not apply to
payments under Clause 5.8.
|
|
|
|
|
|
6.
|
|
PAYMENT TERMS
|
|
|
|
|
|
6.1
|
|
Onyx shall notify BTG within [ * ]
days of any of the Milestone Events being reached.
|
|
|
|
|
|
6.2
|
|
Once a Milestone Event has been
reached Onyx shall pay to BTG the relevant Milestone Payment within
[ * ] days of reaching the Milestone Event. After receipt of such
Milestone Payment, BTG shall issue to Onyx a receipted invoice for
such Milestone Payment.
|
|
|
|
|
|
6.3
|
|
Within [ * ] days of the end of each
Quarter, Onyx shall provide BTG with a royalty statement for that
Quarter setting out the information listed in
Schedule 4.
|
|
|
|
|
|
6.4
|
|
Onyx shall pay to BTG the royalties
due under Clauses 5.5 and 5.6 in respect of the Net Sales Values
generated during any Quarter, within [ * ] days of the end of such
Quarter. After receipt of such royalties, BTG shall issue to Onyx a
receipted invoice for such royalties. Onyx shall pay to BTG the
sums due under Clause 5.8 in respect of Net Receipts received by
Onyx and its Affiliates during any Quarter, within [ * ] days of
the end of such Quarter. After receipt of such sums, BTG shall
issue to Onyx a receipted invoice for such sums.
|
|
|
|
|
|
6.5
|
|
All
sums payable under this Agreement:-
|
|
|
6.5.1
|
|
shall be paid in United States
dollars to the credit of the following bank account of BTG (or to
such other account as BTG may, from time to time, notify to
Onyx):
|
National
Westminster Bank plc
Westminster Branch
P.O. Box 3038
57 Victoria Street
London
SW1H 0HN
US Dollar
payments:
Account number: [ * ]
Sort Code: [ * ]
IBAN BIC [ * ]
|
|
6.5.2
|
|
shall be paid in full without any
deductions or withholdings (including deductions or withholdings in
respect of items such as income tax, corporation tax, or other
taxes, charges or duties) except insofar as Onyx is required by law
to deduct withholding tax from sums payable to BTG in which case
Onyx shall:
|
|
|
6.5.2.1
|
|
ensure that the deduction or
withholding does not exceed the minimum amount legally
required;
|
|
|
|
|
[*]
|
=
|
Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.
|
14
|
|
6.5.2.2
|
|
account to the relevant taxation or
other authorities within the period for payment permitted by the
applicable law the full amount of the deduction or withholding;
and
|
|
|
|
|
|
|
|
6.5.2.3
|
|
provide to BTG within the period for
payment permitted by the relevant law either an official receipt of
the relevant taxation authorities involved in respect of all
amounts so deducted or withheld or if such receipts are not issued
by the taxation authorities concerned a certificate of deduction or
equivalent evidence of the relevant deduction or withholding
sufficient to establish the fact that such amount was remitted to
such taxation authorities, for the purpose of enabling BTG to
obtain credit for the tax deducted or to claim relief from double
taxation under any relevant double taxation treaty;
|
|
|
6.5.3
|
|
shall be paid by the due date for
payment as specified in this Agreement. If Onyx fails to pay any
sum due under this Agreement in whole or part, any outstanding
royalties or other payments due under this Agreement shall bear
interest (calculated on a daily basis) from the date on which they
fell due until payment at a per annum rate of [ * ] and [ * ],
following such failure to pay. The payment of such interest shall
be made in United States dollars. It shall not foreclose BTG from
exercising any other right it may have as a consequence of the
failure of Onyx to make any payment when due.
|
|
6.6
|
|
The
parties shall co-operate to ensure that all sums payable under this
Agreement can be lawfully paid without deduction of withholding
tax, where this is reasonably possible under the laws of the
relevant jurisdiction. Such co-operation shall include, at the
reasonable request of a party, the provision by the other party of
any information required to enable payments to be made without
deduction of tax pursuant to section 911 of the Income Tax Act 2007
(or to any equivalent provision under the laws of the United States
of America or any other relevant jurisdiction) and the prompt
completion and filing of any relevant forms and other documents
with the relevant tax authorities.
|
|
|
|
|
|
6.7
|
|
If
Licensed Products are sold or supplied by Onyx or its Sub-licensees
in a currency other than United States dollars, the royalties
payable in respect of such sales under this Agreement shall be
first determined in the currency of the country in which such sales
took place and then converted into United States dollars at the
rate of exchange as shown in the Financial Times (www.ft.com) on
the last business day of the Quarter in which such sales took
place.
|
|
|
|
|
|
6.8
|
|
If
the Net Receipts received by Onyx or its Affiliates are in a
currency other than United States dollars, the monies payable in
respect of such Net Receipts under this Agreement shall be
converted into United States dollars at the rate of exchange shown
in the Financial Times (www.ft.com) on the last business day of the
Quarter in which the Net Receipts were received by Onyx or its
Affiliates.
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7.
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RECORDS, INSPECTIONS AND
STATEMENTS
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[*]
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Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.
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15
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7.1
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During the term of this Agreement
and for a period of [ * ] years thereafter, Onyx shall, and shall
procure that Onyx’s Affiliates shall, keep at their normal
place of business detailed, accurate and up to date records and
books of account showing the quantity, description and value of all
Licensed Products supplied by Onyx Supplier in each country, all
sums paid to Onyx Supplier in connection with such supply, and all
Net Receipts, in each case during the previous [ * ] years. Onyx
shall ensure that such records and books of accounts are
sufficiently complete and detailed to permit the verification of
the royalties due to BTG under this Agreement.
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7.2
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Onyx shall, and shall procure that
Onyx’s Affiliates shall, make available the records and books
described in Clause 7.1 for inspection during normal business hours
by a qualified accountant of BTG for the purpose of verifying the
accuracy of any statement provided by Onyx to BTG pursuant to
Clause 6.3. BTG’s accountant shall be entitled to obtain such
records and books solely for the purposes of carrying out the
verification.
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7.3
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BTG
shall be entitled to have inspections carried out pursuant to
Clause 7.2 no more frequently than once every Year (and once
following termination or expiry of this Agreement) on giving Onyx
or its Affiliates [ * ] days’ written notice prior to each
inspection. BTG shall not be permitted to have such inspections
carried out more than once with respect to books and records
covering a particular time period unless such re-inspection is
reasonably necessary in order to resolve a discrepancy or concern
that [ * ].
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