CONFIDENTIAL TREATMENT REQUESTED
Where the text of this document has been redacted, it has been marked
"Confidential Treatment Requested." Such redacted portion has been filed
separately with the Securities and Exchange Commission pursuant to Rule 406
promulgated under the Securities Act of 1933, as amended.
Exhibit 10.15
THIS AGREEMENT made in duplicate as of this 9th day of August, 2000.
BETWEEN:
MDS NORDION INC.
having a place of business at
▇▇▇ ▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇
▇▇▇▇▇▇▇, ▇▇▇▇▇▇
("Nordion")
AND:
BOSTON LIFE SCIENCES, INC.
having a place of business at
▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇▇
▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇
("BLSI")
WHEREAS:
I. BLSI is the owner or licensee of a certain compound known as Altropane(tm),
an imaging diagnostic agent for ▇▇▇▇▇▇▇▇▇'▇ disease;
II. Nordion has expertise in the development of pharmaceutical processes and
radiolabelling of compounds;
III. BLSI has developed techniques and demonstrated an ability to label
Precursor with 1-123 to form Altropane;
IV. BLSI desires that Nordion undertake a development program based upon BLSI's
technique at its facility, which will allow BLSI's Precursor to be labeled
with 1-123 to form Altropane;
V. BLSI desires that Nordion establish a facility at its site in Vancouver,
British Columbia, to supply Altropane for use in support of BLSI's drug
submission to the FDA.
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:
ARTICLE 1 - DEFINITIONS
For the purposes of this Agreement:
1.1 "Affiliate" shall mean an entity or person which controls, is
controlled by or is under common control with either party. For purposes
of this Section 1.1 control shall mean (a) in the case of corporate
entities, the direct or indirect ownership of more than one-half of the
stock or participating shares entitled to vote for the election of
directors, and (b) in the case of a partnership, the power to direct the
management and policies of such partnership.
1.2 "Altropane" shall mean a pharmaceutical product containing 1-123 labeled
Precursor in diagnostic dosage form, for use in the diagnosis of
▇▇▇▇▇▇▇▇▇'▇ disease and other disorders.
1.3 "Background Technology" shall mean all Nordion proprietary technology,
including patents, copyright, know-how, techniques, methods, processes
and trade secrets which Nordion owns 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. 1.4
1.4 "Batch" shall mean a production batch of Altropane manufactured under
this Agreement.
1.5 "Clinical Trials" shall mean Phase III human trials for clinical
development of Altropane in the United States.
1.6 "Commercial Phase" shall mean the period of supply of Altropane commencing
after NDA regulatory approval has been received in the United States by
BLSI, from the FDA.
1.7 "Current Good Manufacturing Practices" or "cGMP(s)" shall mean the good
manufacturing practices required by the FDA and set forth in the FD&C
or FDA regulations for the manufacturing, testing and quality control
of pharmaceutical materials as applied to compounds current on the
Effective Date of this Agreement.
1.8 "Development Phase" shall mean the period commencing from the Effective
Date until completion of the activities described in Schedule A.
1.9 "Effective Date" shall mean the date first above written.
1.10 "FDA" shall mean the United States Food and Drug Administration.
1.11 "FD&C" shall mean the United States Federal Food, Drug and Cosmetic Act,
as amended.
1.12 "Facility" shall mean the facility to be established by Nordion at
its manufacturing site in Vancouver, British Columbia as described in
Schedule B, to be used for the production of Altropane for application
in diagnostic purposes.
1.13 "IND" shall mean an Investigational New Drug Application as defined
by the regulations promulgated under the United States FD&C Act and
Public
Health Service Act and any supplements there under, as amended from time to
time.
1.14 "Isotope" or "1-123" shall mean Iodine 123.
1.15 "Master Validation Plan" shall mean the program mutually agreed to
by the parties by which documented evidence provides assurance that the
Process will consistently produce Altropane that meets Specifications.
1.16 "Maximum Batch Size" shall have the meaning attributed in section 4.1.
1.17 "Moveable Equipment" shall mean the equipment identified in Schedule
C and such other equipment as supplied by BLSI to Nordion.
1.18 "NDA" shall mean a new drug application as defined regulations
promulgated under the United States FD&C and Public Health Service Act,
as amended from time to time.
1.19 "Precursor" shall mean cGMP compliant
2p-Carbomethoxy-3p-(4-fluorophenyl)-n-(1 iodoprop-l-en-3-yl)
nortropane as specified in Schedule D.
1.20 "Process" shall mean the method of formulation, dispensing, and testing
of the Altropane developed under this Agreement.
1.21 "Reference Standards" shall mean the cGMP compliant compounds as
specified in Schedule F.
1.22 "Specifications" shall mean those final specifications for Altropane
as set out in Schedule F, as amended by mutual agreement of the
parties from time to time.
ARTICLE 2 - PURPOSE
-------------------
2.1 Scope and Object
---------------------
The scope and object of this Agreement is to carry out the development of the
process in accordance with the development responsibilities and obligations
attributed to each of the parties as set out in this Agreement. In addition,
this Agreement shall provide for the establishment of a Facility at Nordion's
site in Vancouver, British Columbia for the supply of Altropane as required in
support of BLSI's Altropane NDA submission to the FDA.
ARTICLE 3 - DEVELOPMENT PHASE
-----------------------------
3.1 Development Activities
---------------------------
During the Development Phase, Nordion and BLSI shall respectively carry out
their obligations described and attributed in Schedule A, it being understood
that some activities may be reasonably delayed to the extent that such activity
is premised on the work or provision of data, information or technology by the
other party. It is understood and acknowledged that due to the developmental
nature of the activities to be carried out during the Development Phase, the
time for completion and sequence for carrying out the activities as set out in
Schedule A shall serve as a guide. Each party shall use their commercially
reasonable best efforts in order to carry out their respective obligations and
responsibilities set out in Schedule A.
If either party acting in good faith materially fails to satisfy any milestone
or is unable to meet such milestone in accordance with the timing set out in
Schedule A, such party shall provide written notice thereof to the other party
and the
parties shall determine a reasonable corrective action plan and revised
milestone schedule.
The parties acknowledge and agree that Schedule A may be amended during the
course of the Development Phase to accommodate unforeseen events and results.
All such changes to Schedule A shall be made by written agreement of the
parties. Any changes to Schedule A, impacting the scope of work will be
estimated by Nordion, approved in advance by BLSI, and provided at the rates as
set out in section 6.3.
The parties, upon signing this Agreement, shall each designate a program
manager, who shall be responsible for coordinating communication and monitoring
performance under this Agreement. The program managers shall meet monthly, at
locations to be agreed or by telephone, for the purpose of reviewing the status
of the project and to assess progress against the milestones and activities set
forth in Schedule A and for the purposes of determination of percentage of
milestone completed and payments earned under each milestone. Minutes of
meetings shall be prepared, maintained and provided to each of the parties. In
the event of a scope change beyond the services and activities contemplated and
agreed to by the parties as set out in Schedule A prior to commencing such
activities, Nordion shall provide to BLSI a written estimate of any associated
incremental costs. No work on such scope change shall be carried out by Nordion
prior to receipt of BLSI's written approval of such change.
3.2 Development Phase Work
---------------------------
In consideration of Nordion performing the Development Phase services, BLSI
shall pay Nordion in accordance with the rates set out in Schedule G, which
shall include the supply of Altropane for the purpose of producing two (2)
Batches for an equivalency study, as set out in Section 4.1. All amounts due
Nordion shall be paid by BLSI within thirty (30) days of the date appearing on
Nordion's
invoice. Such invoice shall, unless otherwise agreed, be payable in United
States dollars. Ownership of Moveable Equipment, shall remain the property of
BLSI and shall be returned to BLSI upon termination or expiry of this
Agreement. The cost of return and shipment of such Moveable Equipment shall be
to BLSI's account. BLSI acknowledges that some equipment may have radioactive
contamination and may not be returnable to BLSI until the contamination has
been reduced to acceptable limits in accordance with applicable regulations.
The cost of decontamination shall be to BLSI's account.
3.3 Facility Program
---------------------
Upon execution of this Agreement, in consideration of Nordion establishing the
Facility, BLSI will pay to Nordion a facility commitment fee of (CONFIDENTIAL
TREATMENT REQUESTED). In the event this Agreement is terminated within six (6)
months of the Effective Date, Nordion shall, subject to any offset of other
sums owing by BLSI, reimburse to BLSI (CONFIDENTIAL TREATMENT REQUESTED) of
such facility commitment fee. In the event this Agreement is terminated after
six (6) months from the Effective Date and prior to the first anniversary of
this Agreement Nordion shall, subject to any offset of other sums owing by
BLSI, reimburse to BLSI (CONFIDENTIAL TREATMENT REQUESTED) of such facility
commitment fee.
After the Facility is established, Nordion agrees, in consultation with BLSI,
to develop and implement a Master Validation Plan for the Facility that will
allow the production of Altropane under cGMPs to those volumes required by
BLSI, not to exceed the Maximum Batch Size. The costs of preparation,
development and implementation of the Master Validation Plan will be borne by
Nordion. Prior to implementation, both parties shall in writing approve the
Master Validation Plan. Nordion shall ensure that such Facility is available
for the production of Altropane for supply to BLSI on a priority basis.
3.4 Repairs and Maintenance
----------------------------
After the Facility is established, Nordion shall maintain such Facility in
satisfactory operating condition as required by the Specifications, Process and
cGMPs, and all other applicable laws, regulations, rules or orders. The cost of
repairs, preventive maintenance and service contracts for the Moveable
Equipment shall be borne by BLSI. Prior to Nordion entering into third party
preventive maintenance and service/repair contracts for the Moveable Equipment,
Nordion shall obtain BLSI's prior written consent.
3.5 Commercial Phase Negotiations
----------------------------------
Within thirty (30) days after completion of milestone 2 under the Development
Phase, the parties shall for a period of at least sixty (60) days enter into
good faith negotiations for the supply of Altropane to BLSI, during the
Commercial Phase. Indicative pricing for the supply of Altropane is anticipated
to be the order of (CONFIDENTIAL TREATMENT REQUESTED)This pricing does not
include shipping costs. Actual pricing will be subject to good faith
negotiations of a Commercial Phase Supply agreement, it being understood that
the foregoing price reflects a radiolabelling yield of 90, batch sizes
containing a minimum of 100 doses and an Altropane dose containing 5 mCi of
Isotope at noon on the day of use (CONFIDENTIAL TREATMENT REQUESTED)
ARTICLE 4 - BATCH SIZE IN SUPPORT OF NDA SUBMISSION
----------------------------------------------------
4.1 Maximum Batch Size
-----------------------
(CONFIDENTIAL TREATMENT REQUESTED)
ARTICLE 5 - GENERAL MANUFACTURE AND
SUPPLY OBLIGATIONS OF NORDION
-----------------------------
5.1 Altropane Supply
---------------------
As set out in Section 3.2, Nordion agrees to use the Process to produce two (2)
equivalency Batches of Altropane that meets the Specifications and is
manufactured in material conformance with cGMPs and to ship Altropane as
directed by BLSI as required for the purposes of the Master Validation Plan,
for the limited purpose of establishing equivalency between Altropane and
product currently described in BLSI's IND with respect to Altropane. Nordion
reserves the right to withhold from shipment any Batch which does not conform
to Specifications. (CONFIDENTIAL TREATMENT REQUESTED)
5.2 Compliance with Law: Handling of Altropane
-----------------------------------------------
While Precursor, Isotope and Altropane are in its possession or under its
control, Nordion shall as applicable be responsible for its compliance with
statutory and regulatory requirements in the United States and Canada regarding
the development, manufacture, handling, storage, labeling, packaging,
transportation and shipment of the Precursor, Isotope and Altropane.
5.3 Testing and Documentation
------------------------------
Nordion shall maintain production records and BLSI shall have access to such
records in order to determine that each Batch was produced and tested in
compliance with the Specifications and cGMP requirements.
The tests and analyses provided in the Specifications as well as the nature and
form of records may be amended by Nordion from time to time, subject to mutual
agreement and based upon an explanation of such changes provided to BLSI by
Nordion.
ARTICLE 6 - GENERAL BLSI OBLIGATIONS
------------------------------------
6.1 Precursor and Reference Standards
--------------------------------------
BLSI or, at BLSI's discretion, its designee shall provide Precursor and
Reference Standards to Nordion at no charge, which meets the specifications in
Schedules D and E in sufficient quantities to permit Nordion to meet its
obligations hereunder. Nordion shall store Precursor and Reference Standards in
accordance with its applicable specifications. BLSI shall at all times retain
title in and to such materials in Nordion's possession.
6.2 Unavailability or Scarcity of Precursor or Reference Standards
-------------------------------------------------------------------
BLSI will notify Nordion upon BLS1 becoming aware of a shortage of supply of
Precursor or Reference Standards, if such shortage will impact the manufacture
of the Altropane. Except as set out below, BLSI shall not be liable for any
delays in the supply of Precursor or Reference Standards if due to Force
Majeure, provided however, that any such delays in Precursor or Reference
Standards supply will excuse Nordion's performance of activities related to
such Batch of Altropane to the extent Nordion's non-performance was caused by
the Precursor or Reference Standards supply delay.
6.3 Additional Compensation to Nordion
---------------------------------------
BLSI will compensate Nordion based on the rate of (CONFIDENTIAL TREATMENT
REQUESTED) per person per hour for the time spent by Nordion,
(i) preparing and hosting Facility audits requested by BLSI
including FDA preaudit inspections;
(ii) preparing responses to FDA inquiries and preparation by
Nordion of information requested by BLSI in support of BLSI's
Altropane NDA submission;
(iii) attending meetings with the FDA; and
(iv) carrying out implementation of approved scope changes
In addition BLSI shall reimburse Nordion for all licensing fees incurred to
license any controlled substance with respect to Precursor, Reference Standards
or Altropane. BLSI shall reimburse Nordion for all costs incurred for travel
and accommodation in carrying out the foregoing activities. Nordion shall
provide an estimate of all such activities to BLSI.
ARTICLE 7 - ALTROPANE SHIPMENTS
-------------------------------
7.1 Orders and Shipments
-------------------------
During the term of this Agreement, BLSI will forward orders to Nordion at its
Kanata, Ontario facility by facsimile including the identity of the recipient,
delivery destination protocol number, IND number, applicable USNRC materials
license number and IRS number. Delivery of Altropane to BLSI or as otherwise
directed by BLSI shall be FOB transport vehicle at Nordion's facility in
Vancouver, British Columbia. Risk of loss of Altropane shall pass to BLSI at
point of delivery.
During the term of this Agreement Nordion shall use commercially reasonable
best efforts to meet BLSI's orders and delivery requirements. Prior to first
shipment of Altropane to any third party site, BLSI shall obtain from such
third party and provide to Nordion such third party's license evidencing proper
legal authority for the receipt and possession of the Altropane by such third
party. BLSI shall obtain all approvals, licenses and permits required to import
Altropane into the United States. Nordion shall make shipping arrangements with
AirNet Express or such other carrier designated by Nordion and reasonably
approved by BLSI. All shipping costs incurred to deliver Altropane shall be
borne by BLSI.
7.2 Warranty/Recall
--------------------
Nordion warrants the Altropane will meet the Specifications and be manufactured
in accordance with cGMP's and be free from defects in material and workmanship
for the period from the date of manufacture to the expiry date set out on each
vial of Altropane.
If either party discovers that a Batch of Altropane does not meet the
Specifications, then the discovering party shall promptly communicate with the
other party to determine a mutually agreed course of action. If BLS! determines
that the failure to meet Specifications results from an act, failure to act or
other fault of Nordion, or agent of Nordion, Nordion will promptly:
(i) repair or replace such batch of Altropane; and
(ii) pay for shipping costs of replacement of Altropane.
In the event Nordion disputes BLSI's determination that the fault is due to
Nordion and/or its agent, the parties will select a mutually agreeable outside
consulting firm which will be instructed, to review the applicable information
and data and confirm or dissent from BLSI's determination. If the consulting
firm confirms BLSI's determination, Nordion will have the obligations set out
in this section and Nordion will pay the fees of such consulting firm. If the
consulting firm -dissents from BLSI's determination or determines that failure
to meet Specifications was due to products, information or services supplied by
BLSI, Nordion will not have the obligations set out in this section with
respect to the disputed Batch and BLSI will pay the fees of such consulting
firm.
ARTICLE 8 - LICENSE
-------------------
8.1 Royalty-Free License
-------------------------
BLSI hereby provides to Nordion a non-exclusive, nontransferable, royalty-free
license during the term of this Agreement to use the patents, data, information
and technology provided by BLSI relating to Altropane and the radiolabelling of
I-123 with Precursor for the sole purpose of assisting Nordion in carrying out
its obligations set out in this Agreement.
ARTICLE 9 - BLSI REPRESENTATIONS AND WARRANTIES
-----------------------------------------------
9.1 BLSI's Representations and Warranties
------------------------------------------
BLSI represents, warrants and covenants that:
(i) it has full right, power and authority to enter into this Agreement;
(ii) it is the owner or has the right of use of the patents, data, information
and technology supplied to Nordion by BLSI to assist Nordion in
manufacturing Altropane and in carrying out its obligations hereunder;
(iii) to BLSI's best information and belief it is the owner or has the right to
use all data, information, know how, technology and intellectual
property used by BLSI or its designee, in the manufacture of Precursor,
Reference Standards and Altropane;
(iv) there is no action or proceeding pending or insofar as BLSI knows or
ought to know, threatened against BLSI before any court, administrative
agency or other tribunal which might have an adverse material effect on
its business;
(v) it has the right to provide the license in section 8.1 and right to
permit Nordion to use the patents, technology and know how provided to
the extent required to assist Nordion in carrying out its obligations
under this Agreement;
(vi) it has not received any notice of adverse claim or infringement of any
patent, copyright, or misappropriation of trade secrets in connection
with the use and exploitation of the Precursor, reference Standard or
Altropane;
(vii) to BLSI's best information and belief, use or sale of Precursor,
Reference Standards and Altropane and the data, information, technology
and know how used in the Process and manufacture of Altropane contributed
by BLSI do not infringe any valid third party patent, pending published
patent application or other intellectual property right.
ARTICLE 10 - NORDION'S REPRESENTATIONS AND WARRANTIES
-----------------------------------------------------
10.1 Representations and Warranties
-----------------------------------
Nordion represents, warrants and covenants that to the best of its knowledge
and belief:
(i) it has full right and authority to enter into this Agreement;
(ii) it is the owner or has the right to use the data, information and
technology contributed by it with respect to the Background Technology;
(iii) the Background Technology contributed by Nordion does not, infringe any
patents, copyright or other industrial or intellectual property rights
of third parties;
(iv) it has not received any notice of adverse claim of infringement of any
patent or misappropriation of trade secrets in connection with the use
and exploitation of the data, information and technology used with
respect to
Background Technology contributed by Nordion; and
(iv) there is no action or proceeding pending or insofar as Nordion knows or
ought to know, threatened against Nordion before any court,
administration agency or other tribunal which might have a material
adverse effect on Nordion's business.
ARTICLE 11 - INDEMNITY
----------------------
11.1 Indemnification by BLSI
----------------------------
BLSI agrees to indemnify, defend and hold Nordion and its Affiliates and their
respective directors, officers, employees and agents, harmless from and against
any damages, claims, liabilities and expenses (including, but not limited to,
reasonable attorney's fees) resulting from any third party claims or suits
("General Claims Against Nordion") arising out of (a) BLSI's use, handling or
shipment, of Reference Standards, Precursor or Altropane, (b) BLSI's breach of
any of its obligations, warranties or representations hereunder, or (c) BLSI's
negligent acts, omissions or willful misconduct. Notwithstanding the foregoing,
BLSI will not be required to indemnify, defend and hold Nordion and its
Affiliates and their respective directors, officers, employees and agents
harmless from and against any General Claims Against Nordion to the extent that
such claims arise out of (i) Nordion's breach of any of its obligations,
warranties or representations hereunder; (ii) Nordion's negligent acts,
omissions or willful misconduct; (iii) any failure of Nordion to manufacture,
handle, store, label, package, transport or ship Altropane in accordance with
cGMPs or any other applicable laws, regulations, or other requirements of any
applicable governmental entity; or (iv) any failure of Nordion to manufacture
Altropane consistent with applicable sections of BLSI's IND in the United
States. Notwithstanding anything in this Section 11.1, General Claims Against
Nordion shall not include IP Claims Against Nordion as described in Section
11.3.
11.2 Indemnification by Nordion
-------------------------------
Nordion agrees to indemnify, defend and hold BLSI and its Affiliates and their
respective directors, officers, employees and agents, harmless from and against
any damages, claims, liabilities and expenses (including, but not limited to,
reasonable attorney's fees) resulting from any third party claims or suits
("General Claims Against BLSI") arising out of (a) Nordion's manufacture,
handling, storage, labeling, packaging or delivery of the Altropane; (b)
Nordion's breach of any of its obligations, warranties or representations
hereunder; (c) Nordion's negligent acts, omissions or willful misconduct; (d)
any failure of the Altropane to meet the Specifications; or (e) any failure of
Nordion to manufacture, handle, store, label, package, transport or ship
Altropane in accordance with cGMPs or any other applicable laws, regulations or
other requirements of any
applicable governmental entity. Notwithstanding the foregoing, Nordion will not
be required to indemnify, defend and hold BLSI and its Affiliates and their
respective directors officers, employees and agents harmless from and against
any General Claims Against BLSI to the extent that such claims arise out of (i)
BLSI's breach of any of its obligations, warranties or representations
hereunder; (ii) BLSI's negligent acts, omissions or willful misconduct; (iii)
any defect or failure of Reference Standards or Precursor to meet applicable
specifications. Notwithstanding anything in this Section 11.2. General Claims
Against BLSI shall not include IP Claims Against BLSI as described in Section
11.4.
11.3 Intellectual Property Claims Against NORDION
-------------------------------------------------
BLSI agrees to indemnify, defend and hold Nordion and its Affiliates and their
respective directors, officers, employees and agents, harmless from and against
any damages, claims, liabilities and expenses (including, but not limited to,
reasonable attorneys' fees) resulting from any third party claims or suits
arising out of any proceeding instituted by or on behalf of a third party based
upon a claim that the Process, method, manufacture, use or sale of the
Reference Standards, Precursors or Altropane, infringes a United States or
Canadian patent or any other intellectual property or proprietary right of a
third party ("IP Claims Against Nordion"). Notwithstanding the foregoing, to
the extent the Process, is developed or contributed by Nordion, BLSI will not
be required to indemnify, defend or hold harmless Nordion or its Affiliates,
and their respective directors, officers, employees and agents from and against
IP Claims Against Nordion.
11.4 Intellectual Property Claims Against BLSI
----------------------------------------------
Nordion agrees to indemnify, defend and hold harmless BLSI and its Affiliates,
and their respective directors, officers, employees and agents from and against
any damages, claims, liabilities and expenses (including, but not limited to,
reasonable attorney's fees) resulting from any third party claims or suits
arising
out of any proceeding instituted by or on behalf of a third party based upon a
claim that the Background Technology or Process to the extent developed or
contributed by Nordion, infringes a United States or Canadian patent or any
other intellectual property or proprietary right of a third party ("IP Claims
Against BLSI").
11.5 Infringement
-----------------
In the event that any portion of the Background Technology, Process or
technology developed or contributed under this Agreement becomes the subject of
a claim for a patent, copyright or other industrial or intellectual property
rights infringement action by a third party, Nordion reserves the right and may
at its option, based upon evaluation of such claim by legal counsel mutually
selected by Nordion and BLSI,
(i) procure the right to continue using the radiolabelling
technology or if such technology was contributed by BLSI to
require BLSI to procure such right within a reasonable time
not to exceed thirty (30) days;
(ii) modify the Process (to the extent developed or contributed by
Nordion) or require BLSI to modify the Process to become
non-infringing; or
(i) upon written notice to BLSI immediately cease its activities and/or
terminate this Agreement.
The cost and expense of any opinion of counsel sought by Nordion under this
section shall be equally shared by the parties.
11.6 Indemnification Procedures
-------------------------------
A party (the "indemnitee") which intends to claim indemnification under this
Article 11 shall promptly notify the other party (the "Indemnitor") in writing
of any action, claim or other matter in respect of which the Indemnitee or any
of its
directors, officers, employees or agents intend to claim such indemnification;
provided, however, the failure to provide such notice within a reasonable
period of time shall not relieve the Indemnitor of any of its obligations
hereunder except to the extent the Indemnitor is prejudiced by such failure.
The Indemnitee shall permit, and shall cause its directors, officers, employees
and agents to permit the Indemnitor, at its discretion, to settle any such
action, claim or other matter. The Indemnitee agrees to the complete control of
such defense or settlement by the Indemnitor, provided, however, such
settlement does not adversely affect the Indemnitee's right hereunder, admit
liability by Indemnitee or impose any obligations on the Indemnitee. No such
action, claim or other matter shall be settled without the prior written
consent of the Indemnitor, and the Indemnitor shall not be responsible for any
attorney's fees or other costs incurred other than provided herein. The
Indemnitee and its directors, officers, employees and agents shall co-operate
fully with the Indemnitor and its legal representatives in the investigation
and defense of any action, claim or other matter covered by this
indemnification. The Indemnitee shall have the right, but not the obligation,
to be represented by counsel of its own selection and at its own expense.
ARTICLE 12 - PATENTS AND TECHNOLOGY
-----------------------------------
12.1 Ownership of Work Performed
--------------------------------
The Process as developed or contributed by BLSI shall be the sole and exclusive
property of BLSI. Except to the extent the Process is developed or contributed
by BLSI, BLSI agrees and acknowledges, that any and all ideas, technology,
method, data, information, inventions, improvements derivative works and works
of authorship conceived, written, created or first reduced to practice in the
performance of the development of the Process, the Background Technology and
improvements to the Background Technology during the term of this Agreement,
shall be the sole and exclusive property of Nordion.
ARTICLE 13 - REGULATORY MATTERS
-------------------------------
13.1 Regulatory Status
----------------------
Upon Nordion's reasonable request, BLSI shall provide updates to Nordion on (i)
the progress of Clinical Trials related to Altropane, and (ii) submissions to
the FDA and other jurisdictions for marketing authorization with respect to
Altropane.
13.2 BLSI Responsibilities
--------------------------
It shall be the responsibility of BLSI or its designee to file, obtain and
maintain an IND, registrations, listings, authorizations and approvals as the
FDA or other applicable governmental entity may require to enable use of
Altropane in Clinical Trials in the United States. Nordion shall provide
directly to BLSI, or at Nordion's discretion, directly to the regulatory
authority for the purpose of protection of its proprietary technology with
respect to the manufacture of Isotope, all required information in its
possession necessary to assist BLSI in filing, obtaining and maintaining all
licenses, registrations, listings, authorizations and approvals of any
governmental entities necessary for the use of Altropane in support of BLSI's
Altropane NDA submission.
13.3 Nordion Responsibilities
-----------------------------
Nordion shall be responsible for obtaining and maintaining all necessary
facility licenses, registrations, authorizations and approvals which are
necessary to develop, manufacture, handle, store, label, package, transport and
ship Altropane under cGMP conditions and other regulatory requirements
including, but not limited to, the use and handling of radioactive materials
At Nordion's expense, Nordion shall update its existing 1-123 bulk chemical or
facility description Drug Master File ("DMF") with the FDA as may be required
for BLSI's NDA for Altropane in accordance with Schedule A Nordion hereby
grants BLSI a right of reference to such DMF, and upon request shall provide a
letter of access to the DMF allowing regulatory review of the DMF by the FDA in
conjunction with BLSI's Altropane submissions. At Nordion's expense, Nordion
shall apply for and seek a DMF for Altropane in accordance with Schedule A.
13.4 Government Inspections, Compliance Review and Inquiries
------------------------------------------------------------
Upon request of any governmental entity or any third party entity authorized by
a governmental entity, such entity shall, for the purpose of regulatory review,
have access to observe and inspect the Facility and procedures used for the
storage of Reference Standards and Precursor and the manufacturing, testing,
storage and shipping of Altropane, including Process development operations,
and to audit such Facility for compliance with cGMP and/or other applicable
regulatory standards. Nordion shall give BLSI prompt notice of any upcoming
inspections or audits by a governmental entity of the Facility or procedures
and shall, if time permits, allow BLSI to participate in such audits by being
present at the FDA audit close out meeting and shall provide BLSI with a
written summary of such inspection or audit following completion thereof.
Nordion agrees to use commercially reasonable efforts to promptly rectify or
resolve any deficiencies noted by a government entity in a report or
correspondence issued to Nordion.
13.5 Access to the Facility
---------------------------
BLSI shall have reasonable access to the Facility at least once per calendar
quarter during the Development Phase for the purpose of observing Process
development relating to Altropane. BLSI shall provide to Nordion at least ten
(10) business days prior written notice of requested access to the Facility for
the purpose of this Section. All such information disclosed to BLSI or its
employees or agents, shall
be deemed to be Nordion's Confidential Information as such term is defined in
this Agreement.
13.6 Recalls
------------
BLSI shall notify Nordion promptly if Altropane is the subject of a recall or
correction (a "Recall"), and BLSI and/or its designee shall have sole
responsibility for the handling and disposition of such Recall. BLSI and/or its
designee shall bear the costs of any Recall of Altropane unless and to the
extent such Recall shall have been the result of Nordion's or its employees
acts of omissions or any product defects for which Nordion is responsible in
which case Nordion shall to such extent be responsible for BLSI's reasonable
out-of-pocket costs incurred for:
(i) notification of recall to Nordion and third parties;
(ii) return shipment of any defective Altropane to Nordion; and
(iii) replacement of Altropane.
In the event that Nordion disputes BLSI's determination that the fault is due
to Nordion and/or to its agent, the parties will select a mutually agreeable
outside consulting firm which will be instructed to review the applicable
information and data and to confirm or dissent from BLSI's determination. If
the consulting firm confirms BLSI's determination, Nordion will pay the fees of
such consulting firm. If the consulting firm dissents from BLSI's determination
Nordion will not have the obligations set forth herein with respect to the
Recall and BLSI will pay the fees of such consulting firm. BLSI and/or its
designee shall maintain records of all sales, shipping records of Altropane and
customers in sufficient detail to adequately administer a Recall for the period
of time as required by applicable regulation.
13.7 New Regulatory Requirements
--------------------------------
Each party shall promptly notify the other of new regulatory requirements of
which it becomes aware which are relevant to the manufacture of Altropane under
this Agreement and which are required by the FDA and other applicable
governmental entities and the parties shall confer with each other with respect
to the best means to comply with such requirements.
13.8 Records
------------
Nordion shall maintain all records necessary to evidence compliance with (i)
all applicable laws, regulations and other requirements of applicable
governmental entities in the United States and Canada relating to the supply
and manufacture of Altropane; (ii) the Specifications; and (iii) obligations
under this Agreement. All such records shall be maintained by Nordion for at
least two (2) years after termination or expiration of this Agreement. Nordion
shall provide to BLSI reasonable access to such records upon request. Prior to
destruction of any record after such time, Nordion shall give written notice to
BLSI. BLSI shall have the right to request that Nordion maintain such records
in an off site storage facility for such longer periods as BLSI requests,
provided that BLSI pays all costs associated with such off site storage.
ARTICLE 14 - CONFIDENTIALITY
----------------------------
14.1 Confidentiality and Exceptions
-----------------------------------
During the term of this Agreement and for a period of ten (10) years
thereafter, each party hereto shall maintain in confidence the content of the
transactions contemplated herein, all technology including Background
Technology and improvements thereto, Nordion proprietary technology, BLSI
proprietary
technology, trade secrets, know-how, data, processes, methods, techniques,
formulas and test data (collectively "Confidential Information") and other
information disclosed to such party by the other party which is identified as
"Confidential Information" by the disclosing party. 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;
(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.
Each party agrees that it will take the same steps to protect the
confidentiality of the other party's Confidential Information as it takes
to protect its own proprietary and confidential information, which shall
in no event be less than reasonable steps. Each party, and its employees
and agents shall protect and keep confidential and shall not use, publish
or otherwise disclose to any third party, except as permitted by this
Agreement or with the other party's written consent, the other party's
Confidential Information. It is agreed that disclosure of data,
information or technology by BLSI or Nordion to the other under this
Agreement shall not constitute any grant, option or license under any
patent, technology or other rights, held by BLSI or Nordion. Any use of
the data, information and technology provided by BLSI to Nordion which
relates to Precursor, Reference Standards or radiolabelling of Precursor
shall be
for the limited purpose of assisting Nordion in carrying out its obligations
under this Agreement. All data, information, or technology supplied by one
party to the other to assist in carrying out the obligations hereunder shall
remain the property of such party and shall be returned to the other party upon
termination of this Agreement.
ARTICLE 15 - DISCLOSURE OF INFORMATION
--------------------------------------
15.1 Authorized Disclosure
--------------------------
Except as otherwise set out, it is agreed that disclosure of data, information
or technology by Nordion or BLSI, to the other, during the term of this
Agreement 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 BLSI. Notwithstanding section 14.1 each party may disclose Confidential
Information to the extent such disclosure is reasonably necessary for
prosecuting or defending litigation, complying with applicable government laws
or regulations, provided that if a party is required by law or regulation to
make any such disclosure of the other party's Confidential Information it will,
except where impracticable for necessary disclosures, for example, in the event
of medical emergency, give reasonable notice to the other party of such
disclosure requirement and will use its reasonable efforts to secure a
protective order or confidential treatment of such confidential information to
be disclosed.
ARTICLE 16 - TERM AND TERMINATION
---------------------------------
16.1 Initial Term
-----------------
The term of this agreement shall commence upon the Effective Date and, unless
terminated earlier pursuant to this agreement, or extended upon mutual
agreement of the parties, shall expire on the earlier of one (1) year after
completion of Milestone 8 as set out in Schedule A or September 30, 2001.
16.2 Termination Without Cause
------------------------------
BLSI may terminate this Agreement without cause or penalty upon thirty (30)
days prior written notice to Nordion. Upon such termination Nordion shall be
entitled to retain all amounts paid by BLSI, and BLSI shall pay to Nordion any
amounts due and/or earned but not yet paid, and Nordion shall return at BLSI's
expense the Moveable Equipment.
16.3 Termination for Breach
---------------------------
This Agreement may be terminated by either party in the event of the material
breach by the other party of the terms and conditions hereof; provided,
however, the other party shall first give to the breaching party written notice
of the proposed termination of this Agreement (a "Breach Notice"), specifying
the grounds therefore. Upon receipt of such Breach Notice, the breaching party
shall have such time as necessary, but in any event not more than thirty (30)
days to cure such breach. Notwithstanding the foregoing, if the breaching party
does not cure such breach within such cure period, the other party may
terminate the . Agreement without prejudice to any other rights or remedies
which may be available to the non-breaching party.
16.4 Bankruptcy
---------------
This Agreement may be terminated by either party in the event the other party
files a petition in bankruptcy, is adjudicated a bankrupt, or files a petition
or otherwise seeks relief under or pursuant to any bankruptcy, insolvency or
reorganization statute or proceeding, or if a petition in bankruptcy is filed
against it which is not dismissed within sixty (60) days or proceedings are
taken to liquidate the assets of such party.
ARTICLE 17-SURVIVAL
-------------------
17.1 Consequences or Termination or Expiration
----------------------------------------------
Upon expiration or termination of this Agreement, the obligations of the
parties under Articles 9,10,11,12 and 19 and any other Article or section which
by its nature is to survive, shall survive such expiration or termination in
accordance with its terms.
ARTICLE 18-NOTICES
------------------
18.1 Any notice to be sent to a party hereunder shall be forwarded to:
Nordion at: MDS Nordion Inc.
▇▇▇ ▇▇▇▇▇ ▇▇▇▇
▇▇▇▇▇▇, ▇▇
▇▇▇ ▇▇▇
Attention: Senior Vice President, Nuclear Medicine
BLSl at: Boston Life Sciences, Inc.
▇▇▇ ▇▇▇▇▇▇▇ ▇▇, ▇▇▇ ▇▇▇▇▇
▇▇▇▇▇▇, ▇▇
Attention: ▇▇. ▇▇▇▇ ▇▇▇▇▇▇
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 a
nationally recognized overnight courier, or if by electronic facsimile
confirmed by certified or registered mail. Notice shall be deemed delivered
upon receipt.
ARTICLE 19 - LIMITED LIABILITY
------------------------------
19.1 Disclaimer
---------------
In no event shall either party be liable to the other party for indirect,
contingent, incidental, special or consequential damages.
19.2 Limitation of Product Warranty
-----------------------------------
BLSI acknowledges that Nordion is manufacturing and supplying Altropane to meet
Specification. Except as expressly set out in this Agreement, Nordion hereby
disclaims all other warranties or conditions, whether express or implied,
statutory or otherwise, including but not limited to any implied warranties or
conditions of merchantability or fitness for a particular purpose.
ARTICLE 20 - ASSIGNMENT AND SUBCONTRACTING
------------------------------------------
20.1 No Assignment
------------------
This Agreement shall ensure to the benefit of and shall be binding upon the
heirs, executors, administrators, successors and permitted assigns of the
parties. Neither Nordion nor BLSI shall assign any portion of this Agreement
without the
written approval of the other party, which approval shall not be unreasonably
withheld.
ARTICLE 21 - COMPLIANCE
-----------------------
21.1 Compliance with Laws
-------------------------
This Agreement and Nordion's and BLSI's obligations hereunder shall be carried
out in compliance with all applicable laws, by-laws, rules, regulations and
orders of all applicable Federal, State, Provincial and Municipal governments.
ARTICLE 22 - NON-WAIVER
-----------------------
22.1 Non-Waiver of Rights
-------------------------
Failure by either party to enforce at any time any of the provisions of this
Agreement shall not be constructed as a waiver of its rights hereunder. Any
waiver of a breach of any provision hereof shall not be effective unless in
writing and shall not affect either party's rights in the event of any
additional breach.
22.2 Force Majeure
------------------
Neither party shall be liable to the other for failure to perform or delay in
performing its obligations under this Agreement by virtue of the occurrence of
an event of Force Majeure. In the event of Force Majeure, the party affected
shall promptly notify the other and shall exert commercially reasonable efforts
to eliminate, cure or overcome such event and to resume performance of its
obligations. In the event such Force Majeure affecting either party continues
for more than thirty (30) days the party not subject of the Force Majeure may
terminate this Agreement. "Force Majeure" shall mean an occurrence which
prevents, delays or interferes with the performance by a party of any of its
obligations hereunder, if such event occurs by reason of any act of God, flood,
power failure, fire, explosion, casualty or accident, or war, revolution, civil
commotion, acts of public enemies, blockage or embargo, or any law, order or
proclamation of any government, failure of suppliers or usual suppliers to
provide materials, equipment or machinery, interruption of or delay in
transportation, strike or labor disruption, or other cause, whether similar or
dissimilar to those above enumerated provided these are beyond the commercially
reasonable control of such party.
ARTICLE 23 - INSURANCE
----------------------
23.1 Product Liability Insurance
--------------------------------
During the term of this Agreement and for a period of one (1) year thereafter
BLSI at its own expense shall provide and maintain a products liability
insurance policy issued by an insurance company acceptable to Nordion and in a
form acceptable to Nordion, with respect to Altropane. Such policy shall add
Nordion as an additional insured and shall have a limit of liability of not
less than three million United States dollars ($3,000,OOOUS) per occurrence and
in aggregate. BLSI shall be solely responsible for any deductible or retention
associated with this policy and such shall not affect Nordion's interests. The
policy shall contain a cross liability clause and shall provide for
severability of interest such that breach of a policy condition committed by
any one insured shall not adversely affect the rights of the other insured.
Nordion shall be provided thirty (30) days' prior written notice of any
material change to the policy and such change shall be subject to Nordion's
prior written consent, which consent shall not be unreasonably withheld.
Nothing contained in this Section shall be deemed to limit in any way the
indemnification provisions contained in this Agreement.
ARTICLE 24 - PUBLICATION
------------------------
24.1 Publicity
--------------
The parties agree, that except as may otherwise be required by applicable laws,
regulations, rules or orders, no information concerning this Agreement and the
transactions contemplated herein shall be made public by either party without
the prior written consent of the other, which consent shall not be unreasonably
withheld. In the event either party decides to issue a press release announcing
the execution of this Agreement, it shall not do so without the prior written
approval of the other party.
A copy of any proposed press release shall be provided to the other party at
least three (3) business days prior to any proposed release.
In the event that this Agreement or any portion of its contents is required to
be disclosed by BLSI pursuant to Security Exchange Commission regulations in
the United States, BLSI shall provide reasonable notice to Nordion and consult
Nordion prior to any such disclosure in order that the content disclosed not
include what Nordion may reasonably consider confidential, proprietary and
commercially sensitive information.
ARTICLE 25 - DISPUTE RESOLUTION
-------------------------------
25.1 Dispute Resolution
------------------------
Except as otherwise set out, in the event that at any time during the term of
this Agreement, a disagreement, dispute, controversy or claim should arise
relating to the (i) interpretation of or performance under this Agreement or
the attribution of
liability or breach thereof; or (ii) scientific or technical issues in
connection with Nordion or BLSI's performance under this Agreement, the parties
will attempt, in good faith, to resolve their differences for a period of
thirty (30) days. In the event the parties are unable to work out a resolution
of the issue, either party shall be free to take any action and seek any remedy
it may have at law or in equity including specific performance and injunctive
relief.
ARTICLE 26 - INDEPENDENT CONTRACTOR
-----------------------------------
26.1 No Joint Venture
---------------------
The parties agree that with respect to the transactions contemplated herein
that they shall both be acting as independent contractors and nothing herein
shall constitute the parties as entering into a joint venture or partnership,
nor shall constitute either party as an agent of the other for any purpose
whatsoever.
ARTICLE 27 - SEVERABILITY
-------------------------
27.1 Invalid Provisions
------------------------
If any provision or term of this Agreement is found unenforceable under any of
the laws or regulations applicable thereto, all other conditions and provisions
of this Agreement shall nevertheless remain in full force and effect. Upon such
determination that any term or other provision is invalid, illegal or incapable
of being enforced, the parties hereto shall negotiate in good faith to modify
this Agreement to effect the original intent of the parties as closely as
possible in a mutually acceptable manner, in order that the transaction
contemplated hereby be consummated as originally contemplated to the greatest
extent possible.
ARTICLE 28 - AGREEMENT
----------------------
28.1 Entire Agreement
---------------------
This Agreement, including the Schedules hereto which are incorporated herein,
constitute the entire agreement of the parties with respect to the subject
matter hereof and supersedes all proposals, oral or written, and all
negotiations, conversations, or discussions. This Agreement may not be
modified, amended, rescinded, canceled or waived, in whole or in part, except
by written amendment signed by both parties hereto.
ARTICLE 29 - LAW
----------------
30.1 Applicable Law
-------------------
This agreement shall be governed and construed in accordance with the laws of
the Province of Ontario, Canada, without reference to its principles on
conflict of laws. The application of the United Nations Convention for the
International Sale of Goods is expressly excluded.
IN WITNESS WHEREOF the parties hereto have executed this agreement on the date
first above written.
MDS NORDION INC. BOSTON LIFE SCIENCES, INC.
By: /s/ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇ By: /s/ ▇▇▇▇ ▇▇▇▇▇▇
---------------------------- ---------------------
▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇. ▇▇▇▇ ▇▇▇▇▇▇
Vice President Chief Scientific Officer
Sales & Marketing
Schedule A
Scope of Work
(CONFIDENTIAL TREATMENT REQUESTED)
Schedule B
Facility Resources for Contract Manufacture of Altropane
In Manufacturing ▇▇▇▇ ▇▇▇▇ the following equipment is dedicated to Altropane:
.. Laminar Flow Hood for reagent and equipment preparation
.. Three lead shielded stainless steal glove boxes with HEPA filtration and
Nuclear Ventilation
. Box 1 reaction, separation, formulation box containing semi-
preparative automated HPLC for drug substance isolation
. Box 2 has the function to act as a dispensing area. The dispensing
environment is class 100
. Box 3 is the terminal sterilization box containing an autoclave and a
remote handling ball and tong manipulator
. All boxes have been conceptually tested to safely handle 4000 mCi of
I-123 radioactivity
. Boxes feature removable access panels, glove ports, pass through
ports, a waste elevator and some remote feature to reduce technician
radiation dose
.. Specialized shielding assemblies are used for the safe transport of
formulated unit dose radiopharmaceuticals
Some general features of this room and non dedicated support services are:
.. The room is environmentally and radiation monitored
.. There are waste handling systems in place to deal with chemical waste
streams as well as solid and liquid radioactive wastes
.. The entire manufacturing environment is cGMP regulated
.. Qualified and trained staff with experience in diagnostic
radiopharmaceutical manufacture are employed
.. The entire manufacturing facility is supported by a calibration department
.. A fully outfitted microbiology lab is available for microbiological and
environmental tests (Most importantly LAL tests for pyrogenicity).
.. There is an attached microbiology clean room used for sterility tests and
filtration. This clean room contains a class 100 glove box.
Schedule C
Summarized List of Inventory Items received from Boston Life Science
for use in ALTROPANE Analysis
.. 2 Rainin Dynamax variable wavelength UV Detectors
.. 4 Rainin Dynamax HPLC pumps with accompanying stands and mixers
.. 2 Rheodyne 77251 Injectors with loops
.. 1 Complete Dell Optiplex Gxa PC with peripherals and monitor
.. 1 Okidata OL 400 E Printer o One ▇▇▇▇▇ Lite UPS
.. 2 Bioscan Flowcount Detectors with 2 Probes
.. One used Rainin Microscrub HPLC column
.. One used Waters Novapak C-18 HPLC column
.. One used Perkin ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ HPLC column (possibly damaged)
.. One used "black box" custom interface to allow switching of the 2 HPLC
systems
One box of assorted small tools, parts and accessories
Schedule D
Altropane Precursor Specifications
(CONFIDENTIAL TREATMENT REQUESTED)
Schedule E
Reference Standards Specifications
(CONFIDENTIAL TREATMENT REQUESTED)
Schedule F
Altropane Specifications
(CONFIDENTIAL TREATMENT REQUESTED)
Schedule G
Price Schedule
(CONFIDENTIAL TREATMENT REQUESTED)