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EXHIBIT 10.10
THIS AGREEMENT made in duplicate this 15th day of November, 1995,
BETWEEN: NORDION INTERNATIONAL, INC.
a corporation incorporated under the laws of Canada
having a place of business at
000 Xxxxx Xxxx, Xxxxxx, Xxxxxxx, Xxxxxx, X0X 0X0
("Nordion")
AND: XXXXXXX PHARMACEUTICAL, INC.
a corporation incorporated under the laws of Delaware
having a place of business at
000 Xxxxxxxxxx Xxxxxx, Xxxxx 000, Xxxx Xxxx,
Xxxxxxxxxx, X.X.X.
("Xxxxxxx").
WHEREAS:
I Xxxxxxx is the owner of certain data, information and technology
related to labelling of pharmaceutical compounds;
II Nordion has expertise in the development of pharmaceutical processes
and radiolabelling;
III The parties desire to jointly carry out the development of
radiolabelling of B1 antibody with iodine-131 (I-131) radiochemical in
accordance with the terms and conditions set out herein;
IV Xxxxxxx desires to have a clinical supply of I-131 labelled B1 antibody
prepared to support Phase III clinical trials and for commercialization
thereafter. Nordion desires to manufacture and distribute I-131 B1
antibody both for the Phase III clinical trials and for commercial sale
after regulatory approval.
NOW THEREFORE, in consideration of the mutual covenants and agreements herein
contained, and subject to the terms and conditions hereinafter set out, the
parties hereto agree as follows:
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1. Scope and Object
The scope and object of this Agreement is to carry out the joint
development of a pharmaceutical process for I-131 B1 antibody (the
"Project") in accordance with the development responsibilities and
obligations attributed to each of the parties as set out in Schedule A,
which shall serve as a guideline in carrying out this Agreement.
2. Term
The Project and this Agreement shall be deemed to have commenced on
July 10, 1995, which Project may be terminated by either party at any
time upon fifteen (15) days prior written notice.
It is understood and acknowledged that the time for completion and
sequence for carrying out the Project as set out in Schedule A shall
serve only as a guide to achieving the milestones set out in said
schedule.
3. Development and Facility Phases
The Project shall be divided into the following two phases, both of
which are anticipated to be completed within [*] ([*]) months
of the date of commencement of the Project:
(i) Development Phase: Items 2-22, as set out on Schedule A; and
(ii) Facility Phase: Items 23-30, as set out on Schedule A.
This Agreement shall only concern itself with the carrying out of the
Development Phase of the Project. It is anticipated that the Facility
Phase of the Project will cost approximately [*] United States
dollars ($US [*] ), subject however, to any new information acquired
during the Development Phase. The
* Certain confidential information contained in this document, marked by
brackets, has been omitted and filed with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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terms and conditions upon which the Facility Phase will be carried out
will be agreed by the parties under separate contract, to be prepared
and negotiated during the term of the Development Phase.
Nordion shall have a single right of first negotiation for the right to
carry out the Facility Phase and to provide commercial supply of
radiolabelled I-131 B1 antibody. Such negotiations shall be initiated
by Xxxxxxx in writing and shall be ongoing for a period of at least
sixty (60) days. Xxxxxxx shall not, subsequent to successful or
unsuccessful negotiations with Nordion, offer to any third party,
rights to carry out the Facility Phase and to supply for clinical
trials and/or commercial supply, on terms less favorable to Xxxxxxx
than those offered by Nordion. Nordion's right of first negotiation and
this paragraph shall survive termination or completion of this
Agreement for a period of two (2) years.
Clinical trial sites carrying out the radiolabelling of I-131 B1
antibody for the limited purpose of their own in-house use during
clinical trials shall not be a contravention of Nordion's right of
first refusal.
4. Development Activities
Nordion and Xxxxxxx shall respectively carry out their obligations
described and attributed in Schedule A, it being understood that some
development activities may be delayed to the extent that such activity
is premised on the work or provision of data, information or technology
by the other party.
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5. Payments
In consideration of Nordion performing the development services under
the Project, Xxxxxxx shall pay Nordion in accordance with the rates set
out in Schedule B, within thirty (30) days of receipt of an invoice
from Nordion. Such invoice shall, unless otherwise agreed, be payable
in United States currency.
In addition to the rates charged to carry out the development services,
Nordion shall invoice Xxxxxxx on a monthly basis, during the term of
this Agreement, for all equipment purchased and materials consumed in
carrying out the development activities, on the basis of invoice
price plus 5% administration.
Nordion shall keep proper records of the time spent, expenses incurred
and materials consumed in performance of the Project. Subject to
reasonable notice, such records shall be open to audit and inspection
by Xxxxxxx. Nordion shall furnish to Xxxxxxx all additional information
about such records as Xxxxxxx may reasonably require.
6. License
Xxxxxxx hereby provides to Nordion a non-exclusive, non-transferable,
royalty-free license during the Project to use the data, information
and technology, provided by Xxxxxxx related to B1 antibody labelling
for the limited purpose of assisting Nordion in carrying out its
obligations set out in this Agreement.
Xxxxxxx represents, warrants and covenants that (i) it is the owner of
such data, information and technology, (ii) the data, information and
technology do not, to Xxxxxxx'x best information and belief, infringe
any patents, copyright or other industrial or intellectual property
rights of third parties, (iii) it has the right to provide the license
and right to permit Nordion to use the data, information and
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technology to carry out the Project as contemplated herein; and (iv)
has not received any notice of adverse claim or infringement of any
patent.
Xxxxxxx shall indemnify and hold Nordion harmless, from and against,
any allegations, claims, actions or damages arising from infringement
of third party copyright, patents, technology, or other intellectual
property rights, resulting from Nordion's use of any data, information
or technology, as provided by Xxxxxxx hereunder. This indemnity shall
survive termination or completion of this Agreement.
7. Ownership of Work Performed
a) For purposes of this section, "Background Technology" shall mean all
Nordion proprietary technology, including patents, know-how,
techniques, methods, processes and trade secrets which Nordion owns or
uses in performing under this Agreement, or which is licensed to
Nordion and which is in existence in the form of a writing, prototype
or can otherwise be demonstrated to be the property of Nordion, prior
to the effective date of this Agreement.
b) Nordion agrees and Xxxxxxx acknowledges, that any and all ideas,
improvements, inventions and works of authorship conceived, written
created or first reduced to practice in the performance of the Project,
except to the extent that it relates to or embodies the Background
Technology or improvements to the Background Technology, shall be the
sole and exclusive property of Xxxxxxx and Nordion hereby assigns to
Xxxxxxx all right, title and interest in and to any and all such ideas,
improvements, inventions and works of authorship.
c) Nordion further agrees that, except for Nordion's rights in
Background Technology which rights shall remain the sole property of
Nordion, Xxxxxxx is and
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shall be vested with all right, title and interest, including patent,
copyright and trade secret rights in all of Nordion's work produced in
carrying out the Project.
d) [*].
This section shall survive the termination of this Agreement for any
reason including expiration of term.
8. Xxxxxxx Proprietary Information
All data, information, or technology supplied to Nordion by Xxxxxxx to
assist Nordion in carrying out its obligations hereunder, shall remain
the property of Xxxxxxx and shall be returned by Nordion to Xxxxxxx
upon completion or termination of the Project.
9. Patent Applications
a) Nordion shall execute all papers, including patent applications,
invention assignments and copyright assignments, and otherwise shall
assist Xxxxxxx as reasonably required to perfect in Xxxxxxx the rights,
title and other interests in Nordion's work product expressly granted
to Xxxxxxx under this Agreement. Costs related to such assistance, if
required, shall be paid by Xxxxxxx.
b) Notwithstanding any other provision of this Agreement, in the event
that Nordion requests in writing that Xxxxxxx file, maintain and
prosecute a patent application pertaining to rights granted to Nordion
pursuant to Section 7. d) hereof, then Xxxxxxx shall have thirty
(30) days to inform Nordion whether or not such
* Certain confidential information contained in this document, marked by
brackets, has been omitted and filed with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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application will be made. In the event that Xxxxxxx fails to inform
Nordion of its intent to proceed with the requested patent application
within such thirty (30) day period, then Nordion shall have the sole
right to proceed with the filing, prosecution and maintenance of such
patent application, at its sole expense. Any patent resulting therefrom
shall be the sole property of Nordion, subject only to Xxxxxxx'x
non-exclusive, royalty-free and world-wide right to use and sublicense
the use of such patent in connection with products based on the B-1
antibody radiolabelled with 1-131. Xxxxxxx shall execute all papers,
including patent applications and invention assignments, and otherwise
shall assist Nordion as reasonably required to perfect in Nordion the
patent rights described in this section 9.b).
c) This section 9 shall survive the termination of this Agreement for
any reason, including expiration of term.
10. Disclosure of Technology
It is agreed that disclosure of data, information or technology by
Nordion or Xxxxxxx, to the other, during the Project shall not, except
to the extent granted herein, constitute any grant, option or license
under any patent, technology or other rights, held by Nordion or
Xxxxxxx.
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11. Progress Reports
Nordion will provide written reports to Xxxxxxx, on a monthly basis
(prior to the 21st day of the following month), setting out the
progress against milestones as set out in Schedule A.
12. Project Completion Costs
Any expense related to labor or materials which exceed the proposed
estimated project costs of $US[*] will be subject to the prior written
approval of Xxxxxxx.
13. Confidentiality
Except as regards rights in work product obtained by Xxxxxxx in Section
7(b) and 7(c) during the term of this Agreement and for a period of ten
(10) years thereafter, each party hereto shall maintain in confidence
all technology including Background Technology, know-how, data,
processes, methods, techniques, formulas, test data and other
information ("Confidential Information") disclosed to such party by the
other party which, if written, is marked as "Confidential" by the
disclosing party or, if verbal, is reduced to writing and marked
"Confidential" by the disclosing party, within fifteen (15) days of
verbal disclosure. This obligation of confidentiality shall not apply
to the extent that it can be established by the party in receipt of
such information, that the information:
i) was already known to the receiving party at the time of disclosure;
ii) was generally available to the public or otherwise part of the
public domain at the time of its disclosure;
* Certain confidential information contained in this document, marked by
brackets, has been omitted and filed with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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iii) became generally available to the public or otherwise part of the
public domain after its disclosure to the receiving party through
no act or omission of the receiving party;
iv) was disclosed to the receiving party by a third party who had no
obligation to restrict disclosure of such information; or
v) was independently developed by the receiving party without any use
of Confidential Information of the disclosing party.
This section shall survive termination or completion of this
Agreement in accordance with its terms.
14. Indemnity
Nordion and Xxxxxxx, as the case may be, shall indemnify and hold
harmless the other from and against any and all costs, claims,
judgments or other expenses, including reasonable attorney fees,
arising as a result of damages claimed by third parties, in tort,
contract or other legal theory, occasioned by Nordion's or Xxxxxxx'x
negligence or that of their respective employees or agents, in carrying
out their obligations hereunder. This section shall survive termination
or completion of this Agreement.
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15. Termination
Upon termination of this Agreement, Nordion shall forthwith discontinue
its development activities under the Project and shall cancel all
commitments pertaining thereto in an orderly and economic manner. If
this Agreement is so terminated, Xxxxxxx shall be liable to pay to
Nordion for development services rendered, equipment purchased (or
committed to be purchased) and materials consumed, prior to the
effective date of termination. In the event of such termination neither
Nordion nor Xxxxxxx shall have any other right of action on account of
such termination.
16. Notice
Any notice to be sent to a party hereunder shall be forwarded to:
Nordion at: 000 Xxxxx Xxxx
Xxxxxx, Xxxxxxx, Xxxxxx
X0X 0X0
Attention: Vice-President
Technology and Business Development
Xxxxxxx at: 000 Xxxxxxxxxx Xxxxxx, Xxxxx 000, Xxxx Xxxx
Xxxxxxxxxx, X.X.X.
Attention: Vice President, Business Development
Any notice required or authorized to be given by a party to the other
in accordance with the provisions of this Agreement shall, unless
otherwise specifically stipulated, be in writing and delivered
personally, by telegram or electronic facsimile and confirmed by
registered mail.
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17. Assignment
Neither Nordion nor Xxxxxxx shall assign any portion of this Agreement
without the written approval of the other party, which approval shall
not be unreasonably withheld. Nordion shall be entitled to subcontract
to third parties any of its obligations set out in this Agreement in
order to carry out the Project; provided, however, that Nordion may not
subcontract any portion of this Agreement unless such subcontractor
shall agree to be bound by the provisions hereof pertaining to
ownership of work performed and confidentiality.
18. Compliance
The Project shall be carried out in compliance with all applicable
laws, by-laws, rules, regulations and orders of federal, provincial or
municipal governments or manifestations thereof.
19. Non-Waiver
Failure by either party to enforce at any time any of the provisions of
this Agreement shall not be construed as a waiver of its rights
hereunder. Any waiver of a breach of any provision hereof shall not
affect either party's rights in the event of any additional breach.
20. Force Majeure
Neither party hereto shall incur any liability to the other in the
event that it is delayed in the performance of its obligations
hereunder solely by force majeure. For the purpose of this Agreement,
"force majeure" shall mean any cause of delay beyond the reasonable
control of the party liable to perform unless conclusive evidence to
the contrary is provided and shall include, but not by way of
limitation, strikes, lockouts, dots, sabotage, acts of war or piracy,
destruction of essential
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equipment by fire, explosion, storm, flood, earthquake, or delay caused
by failure of power supplies or transport facilities.
21. Applicable Law
This Agreement shall be governed and construed in accordance with the
laws of the Province of Ontario, Canada, without reference to its
conflicts of laws. The venue for any legal proceeding arising out of
this Agreement shall be in the Province of Ontario, Canada.
IN WITNESS WHEREOF the parties hereto have executed this Agreement on the date
first hereinabove written.
NORDION INTERNATIONAL INC.
By: /s/ Xxxxx Xxxxx
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Xxxxx Xxxxx, Vice President,
Business Development and Technology
XXXXXXX PHARMACEUTICAL, INC.
By: /s/ Xxxxxx X. Xxxxxxx
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Xxxxxx X. Xxxxxxx
Vice President, Operations
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SCHEDULE A
[*]
* Certain confidential information contained in this document, marked by
brackets, has been omitted and filed with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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SCHEDULE A
[*]
* Certain confidential information contained in this document, marked by
brackets, has been omitted and filed with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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SCHEDULE B
RATES
Management and documentation $US [*] per hour
Engineering design and laboratory work $US [*] per hour
* Certain confidential information contained in this document, marked by
brackets, has been omitted and filed with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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