1
CERTAIN PORTIONS OF THIS EXHIBIT, DESIGNATED BY AN ASTERISK, HAVE BEEN OMITTED
IN RELIANCE ON RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED
AND A COPY OF THE UNREDACTED EXHIBIT HAS BEEN SUBMITTED TO THE SECURITIES AND
EXCHANGE COMMISSSION
EXHIBIT 10.46
DOPASCAN SUPPLY AGREEMENT
This SUPPLY AGREEMENT is dated as of July 10, 1996 by and
between GUILFORD PHARMACEUTICALS INC., of 0000 Xxxxxxxxx Xxxxxx, Xxxxxxxxx,
Xxxxxxxx 00000 X.X.X. ("Guilford"), on the one hand, and NORDION
INTERNATIONAL INC., of 000 Xxxxx Xxxx, X.X. Xxx 00000, Xxxxxx, Xxxxxxx X0X 0X0
XXXXXX ("Nordion North America"), and its wholly-owned subsidiary NORDION
EUROPE S.A., of Zoning Industriel - B-6220, Fleurus, BELGIUM ("Nordion Europe";
Nordion North America and Nordion Europe collectively, "Nordion"), jointly and
severally, on the other.
WHEREAS, Guilford is the exclusive worldwide licensee of
patent rights relating to radiolabeled RTI-55 (or Beta-CIT) and is developing
same as an imaging diagnostic for Xxxxxxxxx'x Disease under the name,
DOPASCANTM (the "Product"); and
WHEREAS, Guilford and Nordion North America are parties to a
Development and Supply Agreement, dated as of October 12, 1995 (the "North
American Agreement"), pursuant to which Nordion North America has validated
equipment, developed the process and filed a Type II Drug Master File with the
U.S. Food & Drug Administration ("FDA") in respect of and is supplying
Guilford's needs in a U.S. Phase II multi-center clinical trial for the
Product; and
WHEREAS, Guilford seeks a third party contractor to supply
Product for Phase II clinical trials to be conducted in Europe (the "European
Phase II Clinical Trials"); and
WHEREAS, Guilford desires to retain Nordion, and Nordion
desires to be retained by Guilford, to synthesize and supply the Product for
European Phase II Clinical Trials (and thereafter, subject to mutually
satisfactory completion of this Agreement and a separate agreement if any on
mutually acceptable terms including pricing, for Phase III Clinical Trials
and/or commercial distribution in the U.S., Europe and/or elsewhere) on the
terms and conditions contained herein;
NOW, THEREFORE, in consideration of the mutual representations
and covenants contained herein, the parties hereto agree as follows:
1. Scope of Work.
(a) Nordion will, using due care and commercially reasonable
best efforts, perform the work specified in this Agreement relating to
equipment procurement, configuration and validation, and perform regulatory
documentation respecting the supply of the Product for use in European Phase II
Clinical Trials as specified in Schedule A attached hereto, utilizing the
equipment specified in Schedule B attached hereto (the procurement of each
piece of which is subject to the prior approval of Guilford) ("Equipment")
(collectively, the "Work"), and report on and discuss the progress and results
thereof from time to time at the request of Guilford during the term of this
Agreement. The parties understand and
2
CERTAIN PORTIONS OF THIS EXHIBIT, DESIGNATED BY AN ASTERISK, HAVE BEEN OMITTED
IN RELIANCE ON RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED
AND A COPY OF THE UNREDACTED EXHIBIT HAS BEEN SUBMITTED TO THE SECURITIES AND
EXCHANGE COMMISSSION
agree that the Work and the supply of Product contemplated by this Agreement
are to support of Guilford's product, clinical and regulatory development plans
respecting the Product, and ultimately for obtaining approval from European and
other governmental authorities around the world for marketing of the Product.
Nordion will comply with all applicable U.S. and European Good Laboratory
Practices ("GLP"), U.S. and European Good Manufacturing Practices ("GMP") and
other regulations in order for the Work and the supplied Product to meet all
applicable European regulatory requirements for the conduct and completion of
the European Phase II Clinical Trials. Nordion shall prepare any European
equivalent of the FDA Chemistry, Manufacturing and Controls section of any
filing with European regulatory authorities by for the Product. Regulatory
submissions will be prepared according to European Pharmacopeia requirements
and monographs.
(b) Guilford will supply Nordion Europe with sufficient
quantities of RTI-89 as stated in Schedule F attached hereto from time to time
for Nordion Europe to timely perform the obligations under this Agreement, at
no charge to Nordion Europe, F.O.B. Nordion Europe's Fleurus, Belgium
manufacturing facility.
2. Schedule. Nordion shall use commercially reasonable best
efforts to perform and complete the Work, and the various components thereof,
on or before November 4, 1996, pursuant to the timetable set forth in Schedule
A attached hereto, provided that such deadlines will be adjusted appropriately
due to delay caused by Guilford or force majeure under Section 9 below. The
parties agree that, in view of the Work and the importance to Guilford of the
supply of Products pursuant to this Agreement, time and quality are of the
essence in this Agreement.
3. Consideration. As complete and exclusive consideration
for the performance of the Work set forth on Schedule A attached hereto,
Guilford agrees to pay Nordion Europe the amounts set forth on Schedule C
attached hereto (the "Consideration"), which shall be earned and payable in
accordance with that Schedule.
4. Production and Supply.
(a) During the term of this Agreement, Guilford agrees to
purchase from Nordion Europe, and Nordion Europe agrees to produce and supply,
Guilford's entire requirement of Product for the European Phase II Clinical
Trial, which Guilford agrees will not be less than [ * ] Batches (as defined
below) of [ * ] Vials (as defined below) each. Nordion Europe warrants that
all such Product supplied by Nordion Europe shall meet the specifications set
forth in Schedule D attached hereto as delivered at the clinical sites (the
"Specifications") and further represents and warrants that the Specifications
and the methodologies used to synthesize the Product for use in European Phase
II Clinical Trials shall meet all European regulatory requirements in order to
conduct such clinical trials and to support Guilford's (or its designee's)
application for approval to market the Product in Europe. Nordion Europe will
use its commercially reasonable best efforts to supply Product in the
quantities, at the times and at the locations designated by Guilford in
connection with the European Phase II Clinical Trials.
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CERTAIN PORTIONS OF THIS EXHIBIT, DESIGNATED BY AN ASTERISK, HAVE BEEN OMITTED
IN RELIANCE ON RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED
AND A COPY OF THE UNREDACTED EXHIBIT HAS BEEN SUBMITTED TO THE SECURITIES AND
EXCHANGE COMMISSSION
(b) Guilford or its designate shall forward orders to Nordion
Europe's address of Zoning Industriel - B-6220, Fleurus, Belgium, setting out
the recipient, shipping address, protocol number, IND or European equivalent
number, radioactive license number of the Product, quantity and other
applicable instructions and information. Nordion Europe shall process such
orders and ship the requested Product ex-Works Nordion Europe's facility in
Fleuris, Belguim by mutually agreed routings and carriers, appropriately
packaged and documented, within 48 hours of such order therefor as set forth on
Schedule D attached hereto. Upon Nordion Europe's request, Guilford will
obtain and provide to Nordion Europe, prior to shipment by Nordion Europe,
documentation evidencing proper legal authority for the receipt and possession
of the Product by the recipient.
(c) Nordion Europe will manufacture and deliver to the
clinical sites Product in batches ("Batches") of a minimum of [ * ] vials
("Vials"). Each Vial shall constitute one dose of Product suitable for
administration at the clinical site, meeting the radioactivity (5 mCi) and
other Specifications at "Reference" (i.e., noon, Central European Time on the
day immediately following the day of Product synthesis). Prior to (and where
appropriate, following) each shipment, Nordion Europe shall test each Batch in
accordance with the protocol set forth on Schedule E attached hereto and as may
be modified by Guilford from time to time and shall furnish Guilford
(attention: Xxxxxxxxx Xxxxx, Manager of Quality Control) immediately upon
manufacture of each Batch and quality control release and shipment thereof with
a certificate of analysis, batch records, accounting of materials and other
documents in form and content satisfactory to Guilford, and retain all relevant
records pertaining thereto as may be required by GMP regulations and European
Pharmacopeia regulations.
(d) Guilford shall have the right, at reasonable times and
upon reasonable prior notice, to inspect Nordion Europe's development and
manufacturing facilities in order to confirm Nordion Europe's compliance with
GLP, GMP and other applicable European requirements for human pharmaceutical
and testing protocols, conduct quality control/quality assurance audits of the
Work and/or the supply of Product under this Agreement and otherwise in
connection with regulatory matters relating to the conduct of the European
Phase II Clinical Trials. In the event that Guilford observes a condition
which causes it to believe that the Product or its method of development and
production, tests, record keeping or other matters is not in compliance with
GLP, GMP or other regulatory standards applicable to the development of the
Product and the conduct of the European Phase II Clinical Trials, Nordion
Europe and Guilford shall immediately meet (by conference telephone call or
otherwise as appropriate) to discuss the concerns and any additions or
modifications to bring the facilities, procedures or other matters into
compliance. The parties agree to use their commercially reasonable best
efforts to take all steps necessary to bring the production of the Product into
full compliance with all applicable regulations and administrative
requirements. In the event the parties cannot resolve the issue of compliance,
a duly qualified third party expert in applicable European health regulatory
requirements acceptable to both parties and bound by confidentiality, shall be
engaged to resolve the issue, and the decision by such third party expert shall
be binding. The cost incurred with respect to said expert shall be borne by
Guilford. In the event the parties cannot agree on such an expert within 10
days, the parties agree that a qualified internal or external expert named by
The Xxxxxxxx Group, Inc. of Washington, D.C. shall be accepted by the parties.
(e) Nordion Europe agrees to permit European regulatory
authorities and the FDA to inspect Nordion Europe's product development,
manufacturing and other facilities (including the Fleurus facility) and to
cooperate fully with European regulatory authorities and the FDA in connection
with Guilford's conduct of the European Phase II Clinical Trials and Guilford's
regulatory filings relating
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CERTAIN PORTIONS OF THIS EXHIBIT, DESIGNATED BY AN ASTERISK, HAVE BEEN OMITTED
IN RELIANCE ON RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED
AND A COPY OF THE UNREDACTED EXHIBIT HAS BEEN SUBMITTED TO THE SECURITIES AND
EXCHANGE COMMISSSION
thereto, including furnishing information to the European regulatory
authorities and the FDA at Guilford's, the European regulatory authorities' or
the FDA's request, as the case may be. Guilford will reimburse Nordion's
direct out-of-pocket expenses incurred in furnishing any such information to
the European regulatory authorities and/or the FDA.
(f) Without limiting any rights or remedies available to
Guilford, in the event that defective Product or Product not meeting the
Specifications is shipped by Nordion Europe, Guilford, at the request of
Nordion Europe, shall have the right to cause such Product to be returned to
Nordion Europe or destroyed, and Nordion Europe shall on 24 hours notice as
requested by Guilford or its designate re-ship conforming Product, all at
Nordion Europe's cost.
(g) Guilford shall supply sufficient quantities of RTI-89, as
set forth in Section 1.(b) above.
(h) Nordion Europe will use due care in the setup, operation,
calibration and maintenance of the Equipment, normal wear and tear excepted.
(i) Nordion North America covenants to take all necessary and
desirable actions (at its sole cost and expense) to furnish Nordion Europe with
all information in Nordion North America's possession (including but not
limited to production and analytical processes) regarding the Product necessary
to enable Nordion Europe to meet its obligations under this Agreement.
5. Price.
(a) Independent of any sums paid by Guilford to Nordion
Europe with respect to the Work as set forth in Schedule A, attached hereto,
Guilford shall pay to Nordion Europe during the European Phase II Clinical
Trials the following purchase prices based on quantities of Product shipped as
follows: (i) [ * ] per Batch; and (ii) [ * ] per Vial, if any, ordered by
Guilford in excess of the minimum number of vials per Batch. Such prices shall
be exclusive of any additional shipping, handling, customs and all other
charges attendant to delivery of Product at the clinical sites as contemplated
in this Agreement, which charges shall be for the account of Guilford.
(b) Guilford agrees to pay for each quantity of shipped
Product within 30 days from receipt of Nordion Europe's invoice therefor and
the corresponding certificate of analysis and batch records.
6. Term. This Agreement shall commence as of the date first
appearing above and (unless earlier terminated in accordance with the terms
hereof) shall expire upon the earlier of (i) July 31, 1997 and (ii) completion
of the Work and the European Phase II Clinical Trials.
7. Termination.
(a) Prior to completion by Nordion of the Work, this
Agreement may be terminated
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CERTAIN PORTIONS OF THIS EXHIBIT, DESIGNATED BY AN ASTERISK, HAVE BEEN OMITTED
IN RELIANCE ON RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED
AND A COPY OF THE UNREDACTED EXHIBIT HAS BEEN SUBMITTED TO THE SECURITIES AND
EXCHANGE COMMISSSION
upon 10 days' written notice by Guilford. Upon receipt of any such termination
notice, Nordion shall use its commercially reasonable best efforts to wind down
the Work as quickly and economically as possible. Upon any such termination:
(i) Nordion shall be entitled to all payments earned and due (or to become due)
to Nordion as set forth in Schedule C attached hereto; and (ii) Guilford shall
reimburse Nordion for all direct out-of-pocket expenditures relating to
performance of the Work not covered by (i) above, including any cancellation
fees or penalties unavoidably incurred by Nordion, against supporting
documentation in reasonable detail.
(b) Following completion of the Work as set forth in Schedule
A attached hereto, this Agreement may be terminated upon 10 days' written
notice by Guilford in the event Guilford elects for any reason in its sole
discretion to terminate the European Phase II Clinical Trials; provided
however, that in the event Guilford has not yet ordered the [ * ] Batch minimum
requirement set forth in Section 4 hereof (and Guilford is not terminating this
Agreement pursuant to subsections 7(c) or (d) below, in which case no further
payments will be due under this subsection 7(b)), Guilford shall pay to Nordion
Europe upon such early termination under this subsection 7(b) a sum equal to
the difference, if any, between [ * ] and the amount paid or payable by
Guilford to Nordion Europe hereunder for Batches ordered by Guilford pursuant
to Section 4 above.
(c) This Agreement may be terminated by either party upon
material breach by the other and failure to cure within 30 days following
written notice of demand to cure, without prejudice to any and all rights,
remedies and defenses available to the parties hereto.
(d) This Agreement may be terminated by either party in the
event the other party (i) applies for or consents to the appointment of a
receiver, conservator, trustee, liquidator, custodian or other judicial
representative for itself or any substantial portion of its assets or
properties; (ii) admits in writing its inability to pay its debts as they
become due; (iii) makes an assignment for the benefit of its creditors; (iv)
has an order for relief filed by a bankruptcy court for or against it or is
adjudicated insolvent; or (v) files a voluntary petition admitting bankruptcy
or an arrangement with creditors or takes advantage of any bankruptcy,
insolvency, readjustment or debt, dissolution or liquidation law or statute, or
files an answer admitting the material allegations of a petition filed against
it in any proceeding; (vi) or a decree is entered by any court of competent
jurisdiction approving a petition seeking reorganization or appointing a
receiver, conservator, trustee, liquidator, custodian or other judicial
representative, and such order, judgment or decree continues in effect for a
period of sixty (60) consecutive days.
(e) The accrued rights and obligations of the parties shall
not be affected by any termination of this Agreement. Furthermore, upon
termination of this Agreement for any reason by any party, and irrespective of
any claims, rights or remedies either party may have against the other under
this Agreement, Nordion agrees to deliver immediately to Guilford: (i) all
work product (including partial results, drafts and notes, in all tangible
media including electronic format, works in progress and patents, know-how and
other intellectual property) created or worked on by Nordion in, and relating
directly to, the performance of its obligations under this Agreement (provided
that, for the avoidance of doubt, nothing herein shall be deemed to require
Nordion to deliver or transfer its interest in intellectual property owned by
it prior to commencement of performance under this Agreement); (ii) any
inventory
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CERTAIN PORTIONS OF THIS EXHIBIT, DESIGNATED BY AN ASTERISK, HAVE BEEN OMITTED
IN RELIANCE ON RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED
AND A COPY OF THE UNREDACTED EXHIBIT HAS BEEN SUBMITTED TO THE SECURITIES AND
EXCHANGE COMMISSSION
of Product or precursors thereto; (iii) any materials received from Guilford or
other sources in order for Nordion to perform its obligations under this
Agreement; (iv) all Equipment procured by Nordion (shipped in accordance with
Guilford's instructions at Guilford's cost and risk), provided that, in the
event removal of any semi-automatic dispenser purchased and commissioned by
Nordion pursuant to this Agreement is not practical, the parties shall
negotiate in good faith regarding a fair disposition of same; and (v) a report
in reasonable detail outlining the status of the foregoing, and to do all
things and execute documents as Guilford may request to transfer the Drug
Master File or European equivalent to Guilford or its designate, all so that
such termination or the pursuit of any such claims, rights and remedies shall
not interfere with the timely development of the Product by Guilford in its
absolute discretion.
8. Indemnities.
(a) Each party shall indemnify and hold harmless the other
and such other's directors, officers, shareholders, employees and agents
("Indemnitees") from and against all losses, costs or damage (including
reasonable attorney fees and expenses, including allocated in-house legal
costs) suffered or incurred by Indemnitees in respect of damage to or
destruction of property, personal injury or death which may be caused by or
arise from its negligence or that of its directors, officers, employees,
agents, or representatives, except to the extent of the Indemnitees' negligence
or willful misconduct.
(b) If Nordion is subject to allegations of or sued for
patent infringement or infringement of other intellectual property rights
anywhere in the world with respect to its pre-clinical and clinical manufacture
and distribution of the Product pursuant to the terms of this Agreement
initiated by a third party asserting infringement of its rights respecting the
Product, then Guilford will indemnify Nordion and hold Nordion harmless and
defend against such suits. Such indemnification is conditioned upon Nordion
Europe's prompt notification to Guilford of such suit. Guilford shall, at its
expense and sole discretion, have control of such litigation and all matters
related thereto, including settlement.
(c) This Section 8 will survive any termination of this
Agreement.
9. Force Majeure. Neither party shall be held liable to the
other for default or delay in the performance of its obligations under this
Agreement due to an act of God, accident, fire, flood, storm, riot, sabotage,
explosion, strike, labor disturbance, national defense requirements,
governmental law, ordinance rule or regulation, whether valid or invalid,
inability to obtain electricity or other types of energy, raw materials, labor,
equipment or transportation, or any other event beyond its reasonable control.
Each party shall give the other immediate notice of any occurrence of any such
event of force majeure and shall use its commercially reasonable best efforts
to resolve any such occurrence.
10. Confidentiality.
(a) Nordion acknowledges that it may be provided with and
develop confidential and/or proprietary information relating to Guilford, the
Product, the Work, and related matters in the course of its performance under
this Agreement. During the term of this Agreement and thereafter for a period
of fifteen (15) years, Nordion agrees not, either directly or indirectly, to
use for its own benefit or disclose
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CERTAIN PORTIONS OF THIS EXHIBIT, DESIGNATED BY AN ASTERISK, HAVE BEEN OMITTED
IN RELIANCE ON RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED
AND A COPY OF THE UNREDACTED EXHIBIT HAS BEEN SUBMITTED TO THE SECURITIES AND
EXCHANGE COMMISSSION
to any person, company or business any information received or derived from
Guilford except to the extent such information: (i) was in the public domain
at the time Nordion learned of such information under this Agreement; (ii)
comes into the public domain through no fault of Nordion; (iii) except for
information covered by Section 10 of the North American Agreement, was in
Nordion's possession at the time it learned of such information under this
Agreement, and this can be demonstrated with sufficient documentary evidence;
(iv) is obtained by Nordion from third parties not directly or indirectly under
an obligation of confidentiality to Guilford, and Nordion can so demonstrate
with sufficient documentary evidence; (v) is developed independently by Nordion
without reference to such information, and this can be so demonstrated with
sufficient documentary evidence; or (vi) is required by law or requested by the
European regulatory authorities or the FDA in connection with Guilford's
development of or clinical use of the Product.
(b) Nordion may provide Guilford from time to time under this
Agreement with confidential and/or proprietary information relating to Nordion
and its development and manufacturing processes and other matters. Guilford
will keep such information (other than information subject to the exceptions
set forth in Section 10(a)(i) through (vi) above, but with "Guilford" and
"Nordion" substituted for each other in (i) through (v)) confidential, provided
that nothing herein shall be deemed to limit Guilford from developing the
Product and using the information and work commissioned by Guilford and
furnished by Nordion relating to the performance of the Work and the supply of
Products pursuant to this Agreement in connection with Guilford's development
of the Product, conduct of the European Phase II Clinical Trials and regulatory
filings with the FDA and the European and other regulatory authorities
respecting the Product.
(c) If either Nordion or Guilford breaches its obligations
under this Section 10, the other party shall not thereby be released from its
obligations under this Section 10. Confidential information disclosed by one
party hereto to the other which is specific shall not be deemed to be within
any of the above exceptions listed in (i) through (vi) in Section 10(a) above
merely because it is embraced by more general information coming within one of
the exceptions. Any combination of features disclosed to a receiving party
shall not be deemed to be within any exception merely because individual
features thereof fall within one of the exceptions. The provisions of this
Section 10 shall survive any termination of this Agreement.
11. Non-Competition. During the term of this Agreement,
Nordion will not perform development or manufacture and supply services,
whether as principal, agent, third party contractor or otherwise for any
company or business in a manner which directly competes with the Product. A
product shall be deemed to "directly compete" with the Product only in the
event it can be used or developed as an I(1,2,3) imaging diagnostic for
Xxxxxxxxx'x Disease and involves binding to the dopamine transporter.
12. Independent Contractor. Nothing in this Agreement shall
constitute Nordion as an employee or agent of Guilford and at all times Nordion
shall, for all purposes, be an independent contractor.
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CERTAIN PORTIONS OF THIS EXHIBIT, DESIGNATED BY AN ASTERISK, HAVE BEEN OMITTED
IN RELIANCE ON RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED
AND A COPY OF THE UNREDACTED EXHIBIT HAS BEEN SUBMITTED TO THE SECURITIES AND
EXCHANGE COMMISSSION
13. Notices. Any notice given pursuant to this Agreement
will be written and personally delivered, sent by facsimile against answerback,
or mailed by registered or certified mail or via a major recognized overnight
courier service, postage prepaid and return receipt requested, to the parties
addressed as follows:
if to Guilford:
Guilford Pharmaceuticals Inc.
0000 Xxxxxxxxx Xxxxxx
Xxxxxxxxx, Xxxxxxxx 00000
Attention: Xxxx X. Xxxxxxx, Vice President, Operations
Fax No.: (000) 000-0000
if to Nordion:
Nordion Europe S.A.
Zoning Industriel
B-6220
Fleurus, Belgium
ATTN: Xxxxx X. Xxxxxxxxx, Managing Director
Fax No: 000-00-00-000000
with copy to:
Nordion International Inc.
000 Xxxxx Xxxx, X.X. Xxx 00000
Xxxxxx, Xxxxxxx X0X 0X0 XXXXXX
Attention: Xxxxx X.X. Xxxxx, XX Technology & Business
Development
Fax No.: (000) 000-0000
All payments to Nordion Europe S.A., to be paid in BEF, shall be sent to Xxxxx
X. Xxxxxxxx, General Manager, Nordion Europe S.A., Zoning Industriel, B-6220,
Fleurus, Belgium.
All notices shall be effective upon the day of delivery, if personally
delivered or faxed against answerback; the next business day following
dispatch, if sent on a business day by overnight courier; or three business
days after dispatch, if mailed.
14. Governing Law; Jurisdiction. In the event that an
unresolved dispute arises over the enforcement, interpretation, construction,
or breach of this Agreement, it shall be litigated in the U.S. District Court
for Maryland or the Maryland State Circuit Courts located in Baltimore City,
Maryland, U.S.A. and Nordion hereby irrevocably submits to the exclusive
jurisdiction of such courts for all purposes with respect to any legal action
or proceeding in connection with this Agreement. This Agreement shall be
construed in accordance with and governed by the laws of the State of Maryland
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CERTAIN PORTIONS OF THIS EXHIBIT, DESIGNATED BY AN ASTERISK, HAVE BEEN OMITTED
IN RELIANCE ON RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED
AND A COPY OF THE UNREDACTED EXHIBIT HAS BEEN SUBMITTED TO THE SECURITIES AND
EXCHANGE COMMISSSION
(without regard to any rules or principles of conflicts of law that might look
to any jurisdiction outside Maryland).
15. Entire Agreement. This Agreement, the Schedules attached
hereto and Attachment D-1 constitute the entire understanding and agreement of
the parties respecting payment by Guilford for services provided by Nordion to
Guilford relating to the supply of the Product for European Phase II Clinical
Trials and supersedes any and all prior agreements or arrangements, written or
oral, between the parties relating thereto. The foregoing notwithstanding,
this Agreement in no way shall be construed to amend, modify or supersede the
North American Agreement, which remains in full force and effect in accordance
with its terms.
16. Amendments; Waivers. This Agreement may not be amended
or supplemented in any way except by a written document signed by the party
against whom such amendment or supplement is sought to be enforced. The
failure on the part of either party to enforce, or any delay in enforcing, any
right, power or remedy that such party may have under this Agreement shall not
constitute a waiver of any such right, power or remedy, or release the other
party from any obligations under this Agreement, except by a written document
signed by the party against whom such waiver or release is sought to be
enforced.
17. Severability. In the event that any term of this
Agreement is held to be invalid, illegal, or unenforceable, such invalidity,
illegality, or unenforceability shall not affect any other portion of this
Agreement, and there shall be deemed substituted therefor such term as will
most fully realize the intent of the parties as expressed in this Agreement to
the fullest extent permitted by applicable law, the parties hereby declaring
their intent that this Agreement be construed in such fashion as to maintain
its existence, validity, and enforceability to the greatest extent possible.
18. Successors and Assigns; No Assignment. This Agreement
shall be binding upon the respective successors and assigns of the parties
hereto and shall inure to the benefit of and be enforceable by the parties
hereto and their respective successors and assigns, provided, however that this
Agreement may not be assigned by either party without the prior written consent
of the other; provided further, however, that Nordion will not unreasonably
withhold, delay or condition its consent in the event Guilford desires to
assign this Agreement (a) in connection with the transfer or sale of all or
substantially all of its assets or business or its merger or consolidation with
another company or (b) in whole or in part to any corporate affiliate (such
consent to be considered given hereunder in the event that within ten (10) of
the receipt of Guilford's notice of its desire to assign this Agreement,
Nordion does not respond in writing that it is withholding such consent).
19. Intellectual Property. All work product provided or
created or inventions, improvements or developments made or invented by Nordion
relating to the Product and its development, synthesis or manufacture in the
course of performance under this Agreement shall be and remain the property of
Guilford and work made for hire commissioned by Guilford, which shall retain
all intellectual property rights therein, and Nordion will execute all
documents and do all things as Guilford may reasonably request to further vest
Guilford's interest in same. By way of clarification only, nothing
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CERTAIN PORTIONS OF THIS EXHIBIT, DESIGNATED BY AN ASTERISK, HAVE BEEN OMITTED
IN RELIANCE ON RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED
AND A COPY OF THE UNREDACTED EXHIBIT HAS BEEN SUBMITTED TO THE SECURITIES AND
EXCHANGE COMMISSSION
herein shall be deemed or interpreted to require Nordion to deliver or transfer
its interest in intellectual property owned by it prior to the date of this
Agreement first written above.
20. Counterparts. This Agreement may be executed by the
parties hereto in separate counterparts, each of which when so executed and
delivered shall be an original, but all such counterparts shall together
constitute one and the same instrument.
21. Headings. The headings of this Agreement are for
reference only and shall not limit or otherwise affect the meaning of the terms
and conditions of this Agreement.
22. FDA Validation Work. Nordion acknowledges that Guilford
may want, at Guilford's sole option, to use data generated in the European
Phase II Clinical Trials to support Guilford's FDA submissions/applications for
marketing approval for the Product in the United States. Within twenty (20)
days of the date of this Agreement first written above, Guilford and Nordion
Europe will consult with each other regarding (a) performance by Nordion Europe
of additional validation work to ensure compliance with FDA testing protocols
for the Product in order to support any such submission of data from the
European Phase II Clinical Trials to the FDA and (b) the associated additional
costs to Nordion Europe of performing such validation procedures. Guilford
shall, at its sole option, have ninety (90) days beginning from the end of such
twenty (20) day period to require that Nordion Europe conduct such validation
procedures, and Guilford shall promptly reimburse Nordion Europe's direct costs
associated therewith. The precise scope of validation work and payment
schedule shall be set forth in a written addendum to this Agreement signed by
all the parties hereto.
[Remainder of page left intentionally blank]
- 10 -
11
CERTAIN PORTIONS OF THIS EXHIBIT, DESIGNATED BY AN ASTERISK, HAVE BEEN OMITTED
IN RELIANCE ON RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED
AND A COPY OF THE UNREDACTED EXHIBIT HAS BEEN SUBMITTED TO THE SECURITIES AND
EXCHANGE COMMISSSION
IN WITNESS WHEREOF, this Agreement has been executed by the
parties as of the date first above written.
GUILFORD PHARMACEUTICALS INC. NORDION INTERNATIONAL INC.
By: /s/ Xxxx X. Xxxxxxx By: /s/ Xxxxx X.X. Xxxxx
--------------------------------- ---------------------------------
Name: Xxxx X. Xxxxxxx Name: Xxxxx X. X. Xxxxx
Title: Vice President, Operations Title: Vice President, Technology
& Business Development
NORDION EUROPE S.A.
By: Xxxxx X. Xxxxxxxx by
/s/ Xxxxx X. Xxxxxxxx,
Attorney-in-Fact
---------------------------------
Name: Xxxxx X. Xxxxxxxxx
Title: Managing Director
- 11 -
12
CERTAIN PORTIONS OF THIS EXHIBIT, DESIGNATED BY AN ASTERISK, HAVE BEEN OMITTED
IN RELIANCE ON RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED
AND A COPY OF THE UNREDACTED EXHIBIT HAS BEEN SUBMITTED TO THE SECURITIES AND
EXCHANGE COMMISSSION
Schedule A
[ * ]
13
CERTAIN PORTIONS OF THIS EXHIBIT, DESIGNATED BY AN ASTERISK, HAVE BEEN OMITTED
IN RELIANCE ON RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED
AND A COPY OF THE UNREDACTED EXHIBIT HAS BEEN SUBMITTED TO THE SECURITIES AND
EXCHANGE COMMISSSION
Schedule B
EQUIPMENT LIST
[ * ]
NOTE 1: Nordion will use commercially reasonable best efforts to reduce the
acquisition costs of the [ * ] and [ * ] by using a dedicated detector system
on an existing Nordion Europe [ * ] instrument, subject to the mutual agreement
of Nordion and Guilford.
NOTE 2: The two Miscellaneous Equipment items set forth as (e) and (f) above
are firm fixed prices. The prices for all other equipment are estimates, and
such final prices will be based on actual supplier invoices. Purchase of all
Equipment shall be subject to the prior written consent of Guilford, and
Nordion shall not be authorized to purchase any piece of Equipment under this
Agreement without such prior written consent.
14
CERTAIN PORTIONS OF THIS EXHIBIT, DESIGNATED BY AN ASTERISK, HAVE BEEN OMITTED
IN RELIANCE ON RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED
AND A COPY OF THE UNREDACTED EXHIBIT HAS BEEN SUBMITTED TO THE SECURITIES AND
EXCHANGE COMMISSSION
Schedule C
PAYMENT SCHEDULE*
Within 30 days of execution and delivery of Agreement [ * ]** paid in BEF
Within 30 days following:
Completion of Phase I due week 4 [ * ] plus the aggregate
purchase price for
the equipment set
forth on Schedule
B in excess of
the initial [ * ]
payment
Completion of Phase II due week 12 [ * ]
Completion of Phase III due week 16 [ * ]
Completion of Phase IV due week 19 [ * ]
Completion of Phase V due week 23 [ * ]
PHASE I - This Phase of the project is complete when copies of invoices for
the equipment arrive at Guilford. Payment 1, end of week 4.
PHASE II- Installation and Validation. This Phase is completed with copies
of the validation records are shipped to Guilford. Payment 2, end of week 12
PHASE III - Commissioning the Lab and formulation work. The work is consider
complete with the delivery of a copy of the paper work and data from the three
validation runs. Payment 3, end of week 16
PHASE IV - Documentation. Procedure revisions, Translations, STM, SOP's and
specifications that need to be written or re-written. This Phase is completed
when Guilford QC staff verifies the documentation is in place. Payment 4, end
of week 19.
PHASE V - Regulatory phase. This phase is completed with the filing of Type II
DMF or European equivalent with the European authorities. Payment for this
Phase corresponds with the delivery of the development report. Payment 5, end
of week 23.
* All payments shall be made in BEF and shall be remitted no later than 30
days following receipt by Guilford of a duly completed invoice in accordance
with the payment schedule set forth above.
** Represents a prepayment creditable against the purchase price for
Equipment (other than items (e) and (f) set forth on Schedule B)
15
CERTAIN PORTIONS OF THIS EXHIBIT, DESIGNATED BY AN ASTERISK, HAVE BEEN OMITTED
IN RELIANCE ON RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED
AND A COPY OF THE UNREDACTED EXHIBIT HAS BEEN SUBMITTED TO THE SECURITIES AND
EXCHANGE COMMISSSION
Schedule D
SPECIFICATIONS FOR PRODUCTS
TEST SPECIFICATION NOTES
---- ------------- -----
Identify (HPLC) [ * ] 1
Radiochemical purity [ * ]
Radioisotopic purity [ * ] 2
Radioactive concentration [ * ]
Specific activity
(1R)-trimethylstannyl-Beta-CT [ * ] 3
(1R)-Beta-CT [ * ] 4
(1R)-chloro-Beta-CT [ * ] 4
pH [ * ] 4
Visual Inspection [ * ]
Sterility Test [ * ]
[ * ]
Pyrogen Test (LAL) [ * ]
NOTES.
1. [ * ]
2. [ * ]
3. [ * ]
4. [ * ]
SHIPMENT INSTRUCTIONS:
Priority overnight delivery by Nordion Logistics Network according to the
Attachment D-1 attached hereto for delivery at each customer location at times
mutually agreed by the parties. All Product will be shipped at ambient
temperatures. In no event shall delivery of Product to a site occur more than
24 hours following Product synthesis and labeling unless such site is either at
a location not listed on Attachment D-1 or to which delivery cannot be made in
such 24 hour time period as indicated on Attachment D-1 (i.e., sites with a
Delivery Time stated as later than "D+1 less than 12h00"; e.g., remote sites
located in the Spanish islands).
16
CERTAIN PORTIONS OF THIS EXHIBIT, DESIGNATED BY AN ASTERISK, HAVE BEEN OMITTED
IN RELIANCE ON RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED
AND A COPY OF THE UNREDACTED EXHIBIT HAS BEEN SUBMITTED TO THE SECURITIES AND
EXCHANGE COMMISSSION
Schedule E
TESTING PROTOCOL FOR PRODUCTS
PURITY OF [(1,2,3)I]Beta-CIT
[ * ]
STRENGTH
[ * ]
QUALITY
[ * ]
17
CERTAIN PORTIONS OF THIS EXHIBIT, DESIGNATED BY AN ASTERISK, HAVE BEEN OMITTED
IN RELIANCE ON RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED
AND A COPY OF THE UNREDACTED EXHIBIT HAS BEEN SUBMITTED TO THE SECURITIES AND
EXCHANGE COMMISSSION
pH
[ * ]
SPECIFIC ACTIVITY
[ * ]
STERILITY AND APYROGENICITY
[ * ]
STERILITY ASSAY
[ * ]
BACTERIAL ENDOTOXIN ASSAY (LAL TEST)
[ * ]
MODIFICATIONS TO THE ABOVE TESTS
[ * ]
18
CERTAIN PORTIONS OF THIS EXHIBIT, DESIGNATED BY AN ASTERISK, HAVE BEEN OMITTED
IN RELIANCE ON RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED
AND A COPY OF THE UNREDACTED EXHIBIT HAS BEEN SUBMITTED TO THE SECURITIES AND
EXCHANGE COMMISSSION
Schedule F
NON-RADIOACTIVE REFERENCE STANDARDS TO BE SUPPLIED BY GUILFORD
[ * ]
