[***] - INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES AND EXCHANGE
ACT OF 1934, AS AMENDED.
PROCESS DEVELOPMENT AND MANUFACTURING
AGREEMENT
BETWEEN
pSiMEDICA LIMITED
AND
AEA TECHNOLOGY QSA GmbH
INDEX
ARTICLE 1 - DEFINITIONS 5
ARTICLE 2 - PURPOSE 8
ARTICLE 3 - TERM 8
ARTICLE 4 - DEVELOPMENT PHASE 8
ARTICLE 5 - FACILITY PROGRAM 9
ARTICLE 7 - GENERAL MANUFACTURE AND SUPPLY OBLIGATIONS 12
ARTICLE 8 - GENERAL OBLIGATIONS 13
ARTICLE 9 - PAYMENTS 14
ARTICLE 10 - ORDERS AND SHIPMENTS 16
ARTICLE 11 - LICENSE 18
ARTICLE 12 - pSiMEDICA REPRESENTATIONS AND WARRANTIES 18
ARTICLE 13 - pSiMEDICA'S INTELLECTUAL PROPERTY INDEMNITY 19
ARTICLE 14 - QSA'S REPRESENTATIONS AND WARRANTIES 20
ARTICLE 15 - QSA'S INTELLECTUAL PROPERTY INDEMNITY 21
ARTICLE 16 - ARISING INTELLECTUAL PROPERTY 22
ARTICLE 17 - REGULATORY MATTERS 24
ARTICLE 18 - GENERAL INDEMNITY 26
ARTICLE 19 - DISCLOSURE OF TECHNOLOGY 27
ARTICLE 20 - CONFIDENTIALITY 27
ARTICLE 21 - TERMINATION 28
ARTICLE 22 - NOTICES 30
ARTICLE 23 - DISCLAIMER OF CONSEQUENTIAL DAMAGES 31
ARTICLE 24 - ASSIGNMENT 31
ARTICLE 25 - COMPLIANCE 31
ARTICLE 26 - NON-WAIVER 32
ARTICLE 27 - FORCE MAJEURE 32
ARTICLE 28 - INSURANCE 32
2
ARTICLE 29 SEVERABILITY 34
ARTICLE 30 GENERAL 34
ARTICLE 31 - APPLICABLE LAW 35
Schedule A Development Phase 37
Schedule B Facility Description 38
Schedule C Product Description (For Phase IIa Product) 44
Schedule D Source Specifications 45
Schedule E Pricing 49
3
THIS AGREEMENT made in duplicate this 15th day of March, 2004,
BETWEEN: AEA TECHNOLOGY-QSA, GMBH
having a place of business at
Gieselweg 1
D-38110, Braunschweig
GERMANY
("QSA")
AND: pSiMedica Ltd
having a place of business at
Malvern Hills Science Park
Geraldine Road
Malvem, Worcestershire,
WR14 3SZ
UNITED KINGDOM
("pSiMedica")
WHEREAS:
I. pSiMedica is the owner of certain patents, data, information and
technology related to a new biomaterial (BioSilicon(TM)) that it wishes to
be the basis for a potentially new class of P-32 containing "sources" for
use in intratumoural brachytherapy;
II. QSA has expertise in the production and processing of radioactive
material, including the necessary patents, know-how, techniques, methods,
processes and trade secrets for the development and manufacture of sealed
sources and dosimetry;
III. pSiMedica desires that QSA manufactures P-32 BioSilicon(TM) "sources" to
meet pSiMedica's commercial supply requirements; and
IV. pSiMedica desires that QSA develops the required sources, construct a
facility at its subsidiaries sites, initially at Braunschweig, Germany,
and then to manufacture pSiMedica's requirements for P-32 BioSilicon(TM)
sources, in accordance with the terms, conditions and specifications set
out herein.
4
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 "Affiliated Company" shall mean either
(a) a company which is at least majority owned or majority controlled by a
Party hereto or which holds at least a majority interest or majority
control in such Party;
or
(b) a parent company to one of the Parties hereto
1.2 "Batch" shall mean a production batch of P-32 BioSilicon(TM) manufactured
by QSA under this Agreement.
1.3 "Background Technology" shall mean all QSA or its Affiliated Company(s)
proprietary technology, including patents, copyrights, know-how,
techniques, methods, processes and trade secrets which is required for the
purposes of performing the obligations of QSA under this Agreement and
which is owned by QSA or its Affiliated Company(s), or which QSA is
authorized to use, or which is licensed to QSA from third parties and
which is in existence in the form of a written, description, prototype or
can otherwise be demonstrated to be the property of QSA or its Affiliated
Company(s), prior to the Effective Date.
1.4 "Clinical Trials" shall mean human trials for clinical development of the
Medical Device.
1.5 "Commercial Phase" shall mean the period commencing at the date of the
first commercial sale of P-32 BioSilicon(TM) Sources from QSA to pSiMedica
which have been manufactured in the Facility, for pSiMedica after receipt
of marketing authorization from the appropriate Regulatory Authorities and
ending at the date of the last commercial sale of P-32 BioSilicon(TM)
Sources from QSA to pSiMedica.
1.6 "Development Phase" shall mean the period commencing from the Effective
Date until completion to pSiMedica's reasonable satisfaction of the
activities described in Schedule A and any other schedules referred to in
Schedule A.
1.7 "Effective Date" shall mean the date of the signature of this Agreement.
5
1.8 "Equipment(s)" shall mean the moveable assets to be purchased or
manufactured by QSA for and on behalf of pSiMedica. Said equipment will be
detailed in project invoices from QSA to pSiMedica and will be clearly
tagged and identified as pSiMedica property.
1.9 "European Authority" shall mean pSiMedica's Notified Body.
1.10 "Facility" shall mean the production line facility to be constructed by
QSA in its currently existing factory in Braunschweig, Germany, as
described in Schedule B and which will be constructed and installed for
the production of Sources.
1.11 "Facility Program" or "Facility Phase" shall mean the program for the
construction of the Facility as described in Article 5.
1.12 "Hot Cell(s)" shall mean the assets to be purchased or manufactured by QSA
for and on behalf of pSiMedica and installed in the Facility for the term
of this Agreement (unless QSA exercises the option under Article 6.1
(ii)), as more specifically defined in Schedule "B".
1.13 "Improvements" shall mean the extension of Intellectual property gained
during the Term of this Agreement
1.14 "Initial Term" shall have the meaning set forth in Article 3.1 hereof
1.15 "Initial Term Notice" shall mean the written notice by either Party which
shall be given at least eighteen (18) months prior to the end of the
Initial Term and by which the notifying Party informs the other Party that
it does not wish to extend the term of the Agreement beyond the Initial
Term.
1.16 "Isotope" or "P-32" shall mean the Phosphorous-32 in the medical device.
1.17 "Intellectual Property Rights" (IPR) shall mean all intellectual rights
(including but not limited to) rights to inventions, patent rights,
know-how, copyrights and design rights in any part of the world to the
fullest extent and for the full period thereof (including without
limitation any extensions, reversions and renewals) and all rights thereto
and interests therein."
1.18 "Major Repair(s)" shall mean a repair to a given asset entailing
expenditures in excess of the lesser of:
(i) [***] of the subject asset's purchase price as determined at the
time of purchase by the invoice price less any discounts received,
or
(ii) [***].
1.19 "Medical Device" shall mean pSiMedica's P-32 BioSilicon(TM) as described
in Schedule C.
6
1.20 "Minimum Batch Size" shall mean the minimum number of dose vials to be
assembled in one batch and the number of which is to be mutually agreed in
writing prior to the commencement of the Commercial Phase.
1.21 "Notice of Termination" shall mean the written notice given by either
Party to the other Party to terminate the Agreement after the Initial Term
has ended. Notice of Termination must be given at least eighteen (18)
months prior to the date of effective termination.
1.22 "pSiMedica Notified Body" shall mean the appropriately designated medical
authority.
1.23 "pSiMedica Technology" shall mean all pSiMedica proprietary technology,
including patents, know-how, techniques, methods, processes and trade
secrets which is required for the purposes of performing the obligations
of pSiMedica under this Agreement and which is owned by pSiMedica, or
which pSiMedica is authorized to use, or which is licensed to pSiMedica
from third parties and which is in existence in the form of a written,
description, prototype or can otherwise be demonstrated to be the property
of pSiMedica, prior to the Effective Date.
1.24 "Process" shall mean the process of formulation, irradiation, preparation,
dispensing into dose vials, encapsulation, de-encapsulation,
re-encapsulation, inspection and testing of Sources to meet pSiMedica's
Specification.
1.25 "QSA Repairs" shall mean repairs or maintenance to the Equipment and Hot
Cells that are necessary through QSA's negligent abuse, improper
operation, inadequate maintenance, negligence or willful misconduct.
1.26 "Scheduled Batch Completion Date" The date for which QSA has received
final confirmation from pSiMedica that a Batch is required. Such
confirmation from pSiMedica will be given at intervals no less than 14
(fourteen) days prior to when dispatch is required by pSiMedica
1.27 "Specification(s)" shall mean those specifications for the Sources set out
in Schedule D.
1.28 "Source(s)" shall mean the terminally sterilized patient dose vial
produced using the Process which meet the Specifications.
1.29 "Dose vial(s)" shall mean Sources dispensed to an agreed contained
activity and reference date meeting the Specifications suitable for use in
the Medical Device.
1.30 "Transfer Date" shall have the meaning set forth in Article 6.1 sub-clause
(v) hereof.
7
1.31 "United States Authority" shall mean the United States Food and Drug
Administration.
1.32 "Validation" shall mean the program mutually agreed to by the Parties by
which documented evidence provides assurance that the Process will
consistently produce Sources that meet Specifications and quality
attributes, to the reasonable satisfaction of both Parties and the
appropriate Regulatory Authorities.
ARTICLE 2 - PURPOSE
2.1 SCOPE AND OBJECT
The scope and object of the Agreement is to complete the development of
Sources 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 construction
of a Facility at QSA's manufacturing site in Braunschweig, Germany, for
the manufacture of Sources and the supply of Sources for Clinical Trials
and initial commercial sales. It is anticipated that later duplication of
the Facility may be required at other QSA subsidiary sites in order to
follow market demands.
ARTICLE 3 - TERM
3.1 INITIAL TERM
The initial term of this Agreement shall commence upon the Effective Date
and, unless terminated earlier pursuant to this Agreement, shall continue
until the third anniversary of the commencement of the Commercial Phase
("Initial Term").
3.2 EXTENSION
The term of this Agreement shall be automatically extended after
expiration of the Initial Term unless either Party has given Initial Term
Notice to the other Party. At least two years prior to the end of the
Initial Term, the Parties agree to meet in order to discuss, in good
faith, their intentions with respect to whether or not to continue the
term of this Agreement beyond the Initial Term.
ARTICLE 4 - DEVELOPMENT PHASE
4.1 DEVELOPMENT ACTIVITIES
During the Development Phase, QSA and pSiMedica 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
8
Party which such other Party does not provide on a timely basis. Each
Party shall use their best efforts in order to carry out their respective
obligations and responsibilities set out in Schedule "A" to the timescales
specified.
The Parties acknowledge and agree that Schedule "A" may only be amended
during the course of the Development Phase to accommodate unforeseen
events and results beyond the reasonable control of the Parties. All such
changes to Schedule "A" shall be made by written agreement of the Parties.
The Project Managers (as specified at Article 22.1) will meet at least
bi-monthly, at locations to be agreed, including telephone or
videoconferencing, for the purpose of reviewing the status of the project
and to assess progress against the milestones and activities set forth in
Schedule "A". QSA shall also provide written reports to pSiMedica, on a
monthly basis, setting out the progress against milestones set forth in
Schedule "A".
4.2 DEVELOPMENT PHASE TERMINATION
At each review meeting of the Project Managers an assessment shall be made
of the progress of the Development Stage and the ability of both Parties
to fulfill the terms of this Agreement. Should both Parties agree in
writing during the Development Phase that it is no longer possible to
fulfill the terms of this Agreement, then this Agreement shall be
terminated.
ARTICLE 5 - FACILITY PROGRAM
5.1 CONSTRUCTION OF FACILITY
Subject to successful completion of the relevant parts of the Development
Phase to the satisfaction of pSiMedica, QSA shall construct the Facility
at its site in Braunschweig, Germany to carry out the manufacture of
Sources. QSA will use its commercially reasonable best efforts to complete
the Facility Program in accordance with the Gantt chart set forth in
Schedule B. Schedule B may only be modified as agreed in writing by the
Parties.
5.2 FACILITY PROGRAM CAPITAL COST
The actual capital cost of the Facility Program will be calculated on a
time and materials basis as set out in Article 9.1. The facility shall be
completed by QSA on or about 18th May, 2005. The budgeted capital cost for
performance of the Facility Program by QSA is estimated at the Effective
Date to be One million two hundred and forty four thousand one hundred
Euros.((euro) 1,244,100), inclusive of contingency and QSA administration
fees. Any cost in excess of the estimated budgeted capital cost shall be
subject to the prior written authorization of pSiMedica.
9
ARTICLE 6 - ASSET OWNERSHIP
6.1 EQUIPMENT
(i) Under this Agreement QSA will purchase or manufacture, on behalf of
pSiMedica, the Hot Cell(s) and Equipment, which will be installed in
the Facility as described in Schedule B. Upon completion of the
purchase or manufacture of the Hot Cell(s) and Equipment, a warranty
bill of sale in a form reasonably acceptable to pSiMedica, shall be
executed and delivered to pSiMedica transferring full title to such
Hot Cell(s) and Equipment dedicated to pSiMedica requirements free
and clear of all liens, claims, or encumbrances. Subject to
pSiMedica's obligations to transfer ownership of the Hot Cell to QSA
under circumstances as set forth in this Agreement, pSiMedica shall
at all times hold all right, title and interest in the Hot Cell and
Equipment; provided, however, that during the term of this
Agreement, usage thereof shall belong exclusively to QSA for the
purposes of producing Sources for pSiMedica at the Braunschweig,
Germany site. Since the Equipment will be in QSA's possession, QSA
represents and warrants that the Hot Cell(s) and Equipment insofar
as circumstances that are wholly under the control of QSA shall not
be encumbered, and shall, during the term of this Agreement, remain
free and clear of any and all encumbrances including, but not
limited to, mortgages, charges and liens and that no effective
financing statement, pledge or other instrument similar in effect
covering all or any part of the Hot Cell(s) or Equipment has been
agreed or will be agreed by QSA or Parties claiming by, through or
under QSA.
(ii) In partial consideration of the services to be performed hereunder
by QSA and in consideration of the payment of [***] the sufficiency
of which is hereby acknowledged, on the earlier of the natural
expiration or termination of this Agreement by pSiMedica (for
whatever reason other than the default by QSA), should QSA wish to
retain the use of the Hot Cell(s), pSiMedica agrees without further
notice or demand to transfer all of its right, title and interest in
and to the Hot Cell and Equipment to QSA. After transfer of title,
QSA will following such transfer be responsible for any
decontamination or decommissioning costs of the Facility.
(iii) At the conclusion of this Agreement (for what ever reason) the Hot
Cell and other dedicated Equipment at Braunschweig, will need to be
decontaminated and decommissioned. This shall be the responsibility
of pSiMedica unless QSA is able and chooses to exercise its option
to acquire title to the Hot Cells and Equipment. At the time of the
completion of the Facility, on or about 30th December, 2004,
pSiMedica shall establish an Escrow Account for the estimated cost
to Decontaminate and Decommission the Facility [***]This Escrow
Account shall be funded either by an irrevocable letter of credit,
and be held by pSiMedica's attorney. Should QSA decline to exercise
its option, or fail to be allowed to exercise the option due to its
default of this Agreement, to own the Hot Cell and the Equipment,
then upon the natural expiration or termination of this Agreement by
pSiMedica the funds established by PSiMedica in the "Decontamination
and Decommissioning" Escrow Account or through the letter of credit
will be made available to QSA and shall be used exclusively for the
decontamination and decommissioning of the Hot Cell(s) and any other
Equipment prior to their removal by pSiMedica from the Braunschweig
site. Should QSA exercise the option to own the Hot Cell(s) and the
Equipment, then the funds held in the Escrow Account will revert to
pSiMedica or the letter of credit canceled. At each calendar year
end during this Agreement, pSiMedica will increase or decrease the
balance of the Escrow Account or the letter of credit to reflect the
reasonable costs of Decontamination and Decommissioning as estimated
by QSA. If the balance of the Escrow Account exceeds the funds
necessary for Decontamination and Decommissioning, the excess shall
be returned to pSiMedica immediately upon completion of
Decontamination and Decommissioning.
10
(iv) Except as may be provided in accordance with Article 16.1 sub-clause
(ii), in no event may QSA use or permit any third Party to use the
Hot Cell(s) or Equipment for the manufacture of any Sources, any
products which use technology of pSiMedica, or any products which
could compete with the sale of Sources or the Medical Device
(including the Source) by pSiMedica. If title to the Equipment and
Hot Cell(s) is obtained by QSA, QSA may not sell, transfer, lease,
or permit the use of the Hot Cell(s) or the Equipment by third
parties without first notifying pSiMedica and providing pSiMedica
the opportunity to match the terms of any such sale, transfer,
lease, or permit. Should pSiMedica decline to exercise such an
option to purchase or acquire use of the Equipment and Hot Cell(s)
then QSA shall be relieved of all obligations under this Article.
(v) It is understood that pSiMedica may finance the purchase and
construction of the Hot Cell(s) and Equipment through debt and
provide a preferred security interest (Sicherungseigentum) in the
Hot Cell(s) and Equipment to a financing institution or other
lender. Until such time as pSiMedica has made the transfer as set
out in Article 6.1sub-clause(ii) or has otherwise transferred
ownership of the Hot Cell(s) or Equipment as set out elsewhere in
this Agreement (the "Transfer Date"), QSA shall have, and is hereby
granted a secondary security interest (nachrangiges
Anwartschaftsrecht auf Sicherungseigentum) in and to the Hot Cell(s)
behind any security interest provided to any financing institution
or other lender. The secondary security interest in the Hot Cell(s)
and the provision for eventual Decontamination and Decommissioning
set forth above shall be perfected by possession of the Hot Cell(s)
by QSA and shall be effective as of the date of commencement of
installation of such Hot Cell(s) and shall serve as collateral for
the carrying out of the obligations of pSiMedica set out in this
Agreement. Until the Transfer Date, QSA at all times during the Term
of this Agreement shall be entitled to the use and possession of the
Hot Cell(s) and Equipment in accordance with this Agreement, and the
Hot Cell(s) and Equipment, shall be maintained and preserved by QSA
at its expense in accordance with the provisions set out in this
Agreement. pSiMedica shall execute all documents reasonably required
to provide a secondary security interest in and to the Hot Cell(s)
to QSA.
11
(iv) The labor rates and material handling markups on assets constructed
by QSA or its affiliates for this Phase are set forth at Article 9.1
hereto.
ARTICLE 7 - GENERAL MANUFACTURE AND SUPPLY OBLIGATIONS
7.1 SOURCE SUPPLY
QSA agrees to use the Process to produce Sources that meet the
Specifications in conformity with all applicable laws, rules and
regulations of Germany, the European Union and the United States and to
ship Sources as directed by pSiMedica. Subject to the provisions of
Article 27, during the Initial Term of this Agreement and any renewal or
extension thereof, QSA shall manufacture as provided in the preceding
sentence and provide pSiMedica with Sources which shall be ordered by
pSiMedica under this Agreement for the purposes of clinical trials and
commercial sale of the Medical Device.
7.2 BATCH SIZE AND MINIMUM PURCHASE COMMITMENT
pSiMedica agrees that it shall order Sources at the price set forth in
Article 9.3 in batch sizes no smaller than the Minimum Batch Size.
pSiMedica further agrees that it shall purchase from QSA a minimum of
[***] Sources during each twelve months period after commencement of the
Commercial Phase for the remaining period of this Agreement. Should
pSiMedica not order the minimum number of Sources in any twelve month
period from the commencement of the Commercial Phase, then it shall pay
QSA a penalty of [***] for the difference between the number of actual
Sources ordered and the minimum purchase requirement for that period.
7.3 TESTING AND DOCUMENTATION
QSA shall certify in writing, to pSiMedica, and shall provide backup
evidence as requested, that each Batch of Sources was produced and tested
in compliance with:
(i) the Specifications; and
12
(ii) all applicable laws, rules and regulations of Germany, the European
Union and the United States, and in accordance with procedures
agreed between pSiMedica and QSA.
The tests and analyses provided in the Specifications as well as the
nature and form of written certification may be amended from time to time
only by mutual written consent of the Parties.
7.4 REPAIRS AND MAINTENANCE
After the Facility is installed, QSA shall maintain such Facility, Hot
Cell(s) and Equipment in satisfactory operating condition, as required to
enable QSA to manufacture Sources to Specification in accordance with the
Process and all other applicable laws, regulations, rules or orders. In
the event of any conflict between the applicable laws, regulations, rules
or orders, QSA will notify pSiMedica of such conflict and the Parties
shall act in good faith to resolve such conflict or to determine which
laws, regulations, rules or orders should take precedence. Routine
repairs, preventive maintenance and service contracts for the Facility and
Equipment shall be arranged by QSA.
ARTICLE 8 - GENERAL OBLIGATIONS
8.1 ISOTOPE SUPPLY
QSA shall obtain reactor irradiation space sufficient to meet its
obligations hereunder.
QSA shall contract for the supply of the irradiation facility(ies) to
produce the Isotope necessary for QSA's production of Sources pursuant to
this Agreement.
8.2 UNAVAILABILITY OR SCARCITY OF REACTOR IRRADIATION
It is understood that QSA's obligation to supply Isotope is conditional,
depending upon its ability to obtain a sufficient supply of the Isotope by
the reactor irradiation of feedstock doped BioSilicon(TM) supplied by
pSiMedica. QSA will use its best efforts to locate and obtain sufficient
reactor space to produce Isotope to manufacture the Sources required by
pSiMedica. QSA will notify pSiMedica upon QSA's first knowledge of a
shortage or likelihood of any shortage of Isotope if such shortage will
impact the manufacture of the Sources. Except as set out below, QSA shall
not be liable for any delays in the supply of Isotope if due to causes
described in Article 27 hereof.
8.3 PRODUCTION PLANNING FOR CLINICAL TRIAL AND COMMERCIAL SUPPLY
During the first five (5) business days of each month commencing with the
Commercial Phase of this Agreement, QSA and pSiMedica will establish a
schedule of Batch runs for the next twelve (12) weeks. pSiMedica shall
provide QSA with confirmation of Batch orders no later than fourteen (14)
days prior to a Scheduled Batch Completion Date. QSA shall be under an
obligation to deliver to pSiMedica the confirmed Batch order within the
agreed time schedule for such delivery. This approach to production
planning may be modified as mutually agreed to by the Parties based upon
pSiMedica's and QSA's experience in clinical and commercial supply.
13
ARTICLE 9 - PAYMENTS
9.1 DEVELOPMENT AND FACILITY PROGRAM
As with the previous Agreements signed by the two Parties hereto, in
performing the Development Phase QSA will invoice pSiMedica monthly in
arrears, providing an adequate description of the work billed. [***]
In the Facility Program, QSA will provide labor at the hourly billing
rates detailed at Schedule A, [***].
All charges not included in Schedule A or B hereto shall be subject to the
prior written approval of pSiMedica. Charges shall be due only for
services, material and equipment authorized by the terms of Schedule A or
Schedule B. Monthly invoices that include detailed cost statements shall
be submitted to pSiMedica for work performed during the prior month.
[***]
9.2 PAYMENT FOR REPAIRS AND MAINTENANCE
QSA shall be responsible for the payment of all repair and maintenance
costs. pSiMedica will repay all reasonable expenses for any Major Repairs
to or replacement of the Equipment except for QSA Repairs. All costing for
all repairs shall be on the same basis as the Facility Phase.
The maximum amount QSA will be required to pay in any calendar year for
routine repairs, preventive maintenance and service contracts for the
Facility and Equipment shall be [***], plus all amounts required for QSA
Repairs. Any reasonable amounts for routine repairs, preventive
maintenance and service contracts for the Facility and Equipment other
than QSA Repairs in excess of [***] in any calendar year will be borne by
pSiMedica. Preventive maintenance and service contracts for the Equipment
in excess of [***] which are approved in advance by pSiMedica will be
borne by pSiMedica. All amounts set forth in this Article shall be based
on [***] QSA shall co-ordinate with and advise pSiMedica regarding the
advisability of any Major Repair or replacement. The only repairs, if any,
to the Facility or Equipment which shall be borne by pSiMedica are those
set forth in this Article. All other repairs shall be borne by QSA.
14
9.3 PURCHASE PRICE FOR SOURCES
Prior to the commencement of the Commercial Phase, the Parties shall agree
the price that shall be paid by pSiMedica for each Source that QSA
produces to Specification. [***]
9.4 [***]
9.5 PAYMENT TERMS
Except as otherwise provided herein, all invoices shall be paid within 30
days. Where there is any dispute with regard to any item on any cost
statement and or invoice, payment for that item shall be withheld until
such time as any dispute is settled. Payment shall not be withheld from
any item that is not under dispute.
All payments, costs and prices included in this Agreement shall be
exclusive of all taxes.
9.6 CURRENCY
Unless otherwise specified, all sums set out in this Agreement shall be in
Euros.
15
9.7 AUDIT
QSA shall keep accurate books and accounts of record in connection with
the manufacture by it of the Sources in sufficient detail to permit
accurate determination of all figures necessary for verification of all
compensation required to be paid pursuant to Article 9. QSA shall maintain
such records for a period of three (3) years after the end of the year in
which they were generated. These records may be audited by pSiMedica in
accordance with this Agreement, and shall be available for review by
pSiMedica at any time upon reasonable notice.
Except as provided below, pSiMedica, at its sole expense and through its
accounting personnel or, if pSiMedica elects, through an independent
certified public accountant reasonably acceptable to QSA, shall have the
right to examine the books and records of QSA relating to the activities
of QSA hereunder and compensation due QSA hereunder for the sole purpose
of verifying such statements. Such audit shall be conducted upon six (6)
weeks' prior written notice to QSA during ordinary business hours, and
shall not be more frequent than once during each calendar year. pSiMedica
agrees to keep in strict confidence all information learned in the course
of such audits, except when it is necessary to reveal such information in
order to enforce its rights under this Agreement. pSiMedica's right to
have such records examined shall survive termination or expiration of this
Agreement for a period of one (1) year. As each Phase of this Agreement
shall be priced and invoiced in a different manner, any financial audits
undertaken by pSiMedica, shall be done in a way that is appropriate for
the type of pricing and invoicing that was undertaken. In all events, QSA
shall promptly remit to pSiMedica the amount of any overpayment, plus
interest at the rate of 10% per annum from the date such payment was
received by QSA until repaid to pSiMedica. In addition, if the audit
reveals an overcharge of more than ten percent (10%) of the amount due,
QSA shall reimburse pSiMedica for the cost of the related audit and any
costs incident thereto, including attorney's fees and all costs of
collection. Should such audits reveal that QSA have undercharged
pSiMedica, then pSiMedica shall promptly remit to QSA such sums as have
not been recovered.
ARTICLE 10 - ORDERS AND SHIPMENTS
10.1 ORDERS AND SHIPMENTS
During the term of this Agreement, pSiMedica will forward orders to QSA by
facsimile (or other suitable means). Such orders shall include the
identity of the recipient and delivery destination. Delivery of Sources to
pSiMedica or as otherwise directed by pSiMedica shall initially be
ex-Works transport vehicle at QSA's facility in Braunschweig, Germany.
Risk for the goods shall pass to pSiMedica at point of delivery to the
transport vehicle. Title to the goods shall pass to pSiMedica upon QSA
receiving payment from pSiMedica.
16
During the term of this Agreement QSA shall subject to Article 27.1, meet
pSiMedica's orders and delivery requirements.
Prior to the first shipment of Sources to any third Party site, QSA shall
obtain from such third Party its license evidencing proper legal authority
for the receipt and possession of the Source by such third Party. If QSA
is unable to obtain such license from the third Party, pSiMedica, upon
QSA's request, shall obtain and provide such evidence of legal authority
for the receipt and possession of the Source by such third Party.
pSiMedica shall obtain all approvals, licenses and permits required to
import the Source into any territory where pSiMedica directs shipments to
be sent.
QSA shall make shipping arrangement with carriers designated in writing by
pSiMedica from the ex-Works point to the delivery site. All transportation
and packaging costs incurred to deliver Sources ordered by pSiMedica shall
be borne by pSiMedica.
10.2 BATCH NOT MEETING SPECIFICATIONS
If either Party or its designee discovers that a Batch of Sources does not
meet the Specifications, then the discovering Party shall promptly
communicate in writing with the other Party to determine a mutually agreed
course of action. With respect to any such Batch of Sources which do not
meet Specifications as a result of shortcomings in process or parameters
under the direct control of QSA, then QSA will promptly:
(i) replace such Batch of Sources at no additional cost (with QSA also
paying all costs to deliver such replacement Batch to the pSiMedica
designated site);
(ii) reimburse pSiMedica for its actual costs incurred to return the
Sources to QSA and for any purchase price paid by pSiMedica for such
Sources; and
(iii) indemnify pSiMedica for any other costs it incurs by reason of such
Batch of Sources or single Source not meeting Specifications. [***]
10.3 INVENTORY REQUIREMENTS
Within one month of the commencement of the Commercial Phase of this
Agreement, QSA shall maintain a reasonable minimum Source inventory of
Sources to be agreed between the parties which will have a value according
to the pricing agreed in Schedule E. This minimum inventory stock level
shall be reviewed by QSA and pSiMedica at quarterly intervals to ensure
compatibility with forecasted purchasing volumes. Upon Termination of this
Agreement for any reason whatsoever, pSiMedica shall purchase the minimum
inventory stock at QSA.
17
ARTICLE 11 - LICENSE
11.1 ROYALTY FREE LICENSES
pSiMedica hereby provides to QSA a non-exclusive, non-transferable,
royalty free license during the term of this Agreement to use pSiMedica
Technology, for the sole purpose of assisting QSA in carrying out its
obligations set out in this Agreement. QSA hereby provides to pSiMedica a
non-exclusive, non-transferable, royalty free license during the term of
this Agreement to the Background Technology, for the sole purpose of
assisting pSiMedica in carrying out its obligations set out in this
Agreement.
ARTICLE 12 - PSIMEDICA REPRESENTATIONS AND WARRANTIES
12.1 PSIMEDICA REPRESENTATIONS AND WARRANTIES
pSiMedica represents, warrants and covenants that:
(i) it has full right, power and authority to enter into this Agreement;
(ii) it is the owner or licensee, in Germany, the United Kingdom and the
United States, of the patents, data, information and technology
supplied to QSA by pSiMedica to assist QSA in carrying out its
obligations hereunder;
(iii) exercise of the patent(s) and technology provided by pSiMedica do
not, to pSiMedica's best information and belief, infringe any
patents, copyright or other industrial or intellectual property
rights of third parties;
(iv) it has the right to provide any license and right to permit QSA to
use the patents and technology related to the Sources provided to
the extent required to assist QSA in carrying out its obligations
under this Agreement;
(v) it has not received any notice of adverse claim or infringement of
any patent or misappropriation of trade secrets in connection with
the use and exploitation of the patents, data, information and
technology provided hereunder and related to the Sources; and
(vi) this Agreement has been duly authorized by all necessary corporate
action and constitutes a valid and binding agreement of pSiMedica,
enforceable in accordance with its terms.
(vii) it has complied with all corporate formalities required to legally
bind it to this Agreement;
(viii) it has executed no agreement in conflict herewith;
18
(ix) it shall exercise its rights and engage in activities hereunder in a
workmanlike manner, using reasonable care and
(x) it shall at its sole cost and expense, comply with all laws and
regulations and obtain all governmental approvals, regulatory
approvals applicable to the exercise its rights and the engagement
of its activities under this Agreement
The foregoing representations and warranties shall be in lieu of and shall
exclude all other warranties (as conditions) expressed or implied,
statutory or otherwise, including any implied warranties (as conditions)
of merchantability or fitness for a particular purpose.
ARTICLE 13 - PSIMEDICA'S INTELLECTUAL PROPERTY INDEMNITY
13.1 INDEMNIFICATION OF QSA
pSiMedica hereby agrees to indemnify, defend and hold QSA, its Affiliates
and all of the officers, directors, employees, and agents of QSA and its
Affiliates harmless from any and all damages directly suffered by them
arising out of or related to (a) the breach or falsity of any
representation of pSiMedica contained herein or (b) the negligent or
willful misconduct of pSiMedica or its officers, directors, employees or
agents, or (c) any breach by pSiMedica of its obligations hereunder.
pSiMedica shall indemnify and hold QSA harmless from and against any
liabilities, claims, damages and expenses (including reasonable attorney's
fees) which QSA may be compelled to pay in any judgment, claim or action
arising from infringement, of third Party copyright, patents, technology
or other intellectual property rights, resulting from QSA's use, in
accordance with the this agreement, of any data, information, technology
or patents, as provided by pSiMedica hereunder. QSA shall give written
notice of any such legal action promptly after QSA's first knowledge
thereof. pSiMedica shall have sole and exclusive control of the defense of
any legal action, including the choice and direction of any legal counsel.
QSA may not settle nor compromise any legal action without the prior
written consent of pSiMedica. This indemnity shall survive termination of
the Agreement.
This Article shall not apply to any liability resulting from the use of
the aforementioned intellectual property for unauthorized purposes.
In the event that any portion of the pSiMedica Technology is, in
pSiMedica's reasonable opinion, likely to or does become the subject of a
claim for a patent, copyright or other industrial or intellectual property
rights infringement, pSiMedica reserve the right and may at its option:
19
(i) procure the right to continue using the pSiMedica Technology; or
(ii) modify the pSiMedica Technology to become non-infringing.
ARTICLE 14 - QSA'S REPRESENTATIONS AND WARRANTIES
14.1 QSA'S REPRESENTATIONS AND WARRANTIES
QSA represents, warrants and covenants that:
(i) It has full right and authority to enter into this Agreement;
(ii) It is the owner or has legal rights of use of its data, information
and technology contributed with respect to the Process;
(iii) The data, information and technology contributed by QSA does not, to
QSA's best information and belief, 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 secret or any other
intellectual property rights in connection with the use and
exploitation of the data, information and technology used with
respect to the Process;
(v) There is no action or proceeding pending or insofar as QSA knows or
ought to know, threatened against QSA before any court,
administrative agency or other tribunal which might have a material
adverse effect on QSA's business; and
(vi) This Agreement has been duly authorized by all necessary corporate
and government action and constitutes a valid and binding agreement
of QSA, enforceable in accordance with its terms.
(vii) it has complied with all corporate formalities required to legally
bind it to this Agreement;
(viii) it has executed no agreement in conflict herewith;
(ix) it shall exercise its rights and engage in activities hereunder in a
workmanlike manner, using reasonable care and
(x) it shall at its sole cost and expense, comply with all laws and
regulations and obtain all governmental approvals, regulatory
approvals applicable to the exercise its rights and the engagement
of its activities under this Agreement
20
14.2 SOURCE PRODUCT WARRANTY
QSA warrants that the Product will be free from defects and conform to
pSiMedica's specification but QSA's sole liability for breach of this
warranty shall be as stated in Article 10.2 provided that the failure or
defect is shown to QSA's reasonable satisfaction to be due to QSA's faulty
workmanship, material or packaging and not to any defect in pSiMedica's
Background Technology.
The period of warranty in this Article 14.2 shall extend for a period of
60 days from the date of receipt of the Product by pSiMedica or
pSiMedica's customers or the end of the Product expiry date, whichever is
sooner.
ARTICLE 15 - QSA'S INTELLECTUAL PROPERTY INDEMNITY
15.1 INDEMNIFICATION OF PSIMEDICA
QSA hereby agrees to indemnify, defend and hold pSiMedica, its Affiliates
and all of the officers, directors, employees and agents of pSiMedica and
its Affiliates harmless from any and all damages arising out of or related
to (a) the breach or falsity of any representation of QSA contained
herein, (b) the negligent or willful misconduct of QSA or its officers,
directors, employees or agents, or (c) any breach by QSA of its
obligations hereunder, including without limitation its obligation to
comply with standard operating procedures.
QSA agrees to defend, indemnify and hold pSiMedica, its officers,
directors and employees harmless from and against any liabilities, claims,
damages and expenses (including reasonable attorneys' fees) which
pSiMedica and such indemnified Parties may be compelled to pay in any
judgment, claim or action arising from infringement of third Party
copyright, patents, technology or other intellectual property rights
resulting from pSiMedica's use under this Agreement of Background
Technology. pSiMedica shall give written notice of any legal action
promptly after pSiMedica's first knowledge thereof. QSA shall have sole
and exclusive control of the defense of any legal action, including the
choice and direction of any legal counsel. pSiMedica may not settle nor
compromise any such legal action without the written consent of QSA. This
indemnity shall survive termination of this Agreement.
In the event that any portion of the Background Technology developed is,
QSA's reasonable opinion, likely to or does become the subject of a claim
for a patent, copyright or other industrial or intellectual property
rights infringement, QSA reserves the right and may at its option:
(i) procure the right to continue using the technology; or
(ii) modify the technology to become non-infringing.
21
15.2 ARISING INTELLECTUAL PROPERTY INDEMNITY
In the event that any portion of the technology developed under this
Agreement is, in either Parties reasonable opinion, likely to or does
become the subject of a claim for a patent, copyright or other industrial
or intellectual property rights infringement, either Party reserves the
right and may at its option:
(i) procure the right to continue using the technology; or
(ii) modify the technology to become non-infringing.
ARTICLE 16 - ARISING INTELLECTUAL PROPERTY
16.1 OWNERSHIP OF IMPROVEMENTS
All Intellectual Property Rights in any Improvements conceived, written,
created, developed or first reduced to practice in and related to the
performance of this Agreement that relate to the pSiMedica Technology or
BioSilicon(TM) generally ("pSiMedica Improvements") will be owned solely
by pSiMedica irrespective of who conceives, writes, creates, develops or
first reduces to practice any such Improvements.
All Intellectual Property Rights in any Improvements conceived, written,
created, developed or first reduced to practice in and related to the
performance of this Agreement that relate to Background Technology ("QSA
Improvements") will be owned solely by QSA irrespective of who conceives,
writes, creates, develops or first reduces to practice any such
Improvements.
All Intellectual Property Rights in any Improvements conceived, written,
created, developed or first reduced to practice in and related to the
performance of this Agreement that do not relate to either the pSiMedica
Technology or the Background Technology, will be jointly owned by
pSiMedica and QSA, irrespective of who conceives, writes, creates,
develops or first reduces to practice any such Improvements and both
pSiMedica and QSA shall, except as otherwise stated in this clause, have
free use of such Improvements. Each Party on behalf of its stockholders,
directors, employees, officers, Subsidiaries and representatives hereby
assigns to the other party all Intellectual Property Rights in all such
jointly owned Improvements. However neither Party shall utilize such
jointly owned Improvements in conjunction with any third party without the
prior written approval of the other party, which approval if given may be
subject to any conditions that the other party reasonably determines but
shall not be unreasonably withheld.
In the event that pSiMedica is acquired or assigns a manufacturing license
for the production of its P-32 BioSilicon(TM) that results in production
other than by utilising the ongoing services of QSA and pSiMedica assets
residing at QSA facilities, then pSiMedica, its heirs, successors or
assigns shall be entitled to:
22
a) use any QSA Improvement which is made, developed or acquired by QSA,
for its own purposes by way of a non-exclusive license without limit
of time in exchange for a reasonable royalty
b) use the relevant Background Technology necessary to operate the
manufacturing process by way of a non-exclusive license without
limit of time in exchange for a reasonable royalty
QSA will do all acts and things necessary to become the owner of any
intellectual property rights arising out of the performance of the
Agreement and to which pSiMedica can possibly be entitled or have a right
to. In particular, QSA should, after consultation with pSiMedica, be
obliged to claim all rights to inventions of their employees invented in
the performance of the Agreement
16.2 PSIMEDICA IMPROVEMENTS
QSA:
must notify pSiMedica in writing of all pSiMedica Improvements promptly
following such Improvements being conceived, written, created, developed
or first reduced to practice by any of its employees, officers, agents,
contractors or other personnel engaged by QSA in and related to the
performance of this Agreement; must upon pSiMedica's request, provide all
details relating to any pSiMedica Improvements in a form specified by
pSiMedica; hereby assigns all Intellectual Property Rights in all
pSiMedica Improvements topSiMedica; and
must do all things directed by pSiMedica, including executing such
documents, which pSiMedica considers necessary in order to assign to
pSiMedica and otherwise absolutely vest title in pSiMedica to all
Intellectual Property Rights in such pSiMedica Improvements.
16.3 QSA IMPROVEMENTS
pSiMedica:
must notify QSA in writing of all QSA Improvements promptly following such
Improvements being conceived, written, created, developed or first reduced
to practice by any of its employees, officers, agents, contractors or
other personnel engaged by pSiMedica in and related to the performance of
this Agreement; must upon QSA's request, provide all details relating to
any QSA Improvements in a form specified by QSA; hereby assigns all
Intellectual Property Rights in all QSA Improvements to QSA; and must do
all things directed by QSA, including executing such documents, which QSA
considers necessary in order to assign to QSA and otherwise absolutely
vest title in QSA to all Intellectual Property Rights in such QSA
Improvements.
23
16.4 SURVIVAL OF ARTICLE 16
This Article 16 shall survive the termination of this Agreement for any
reason including expiration or termination of this Agreement.
ARTICLE 17 - REGULATORY MATTERS
17.1 PSIMEDICA RESPONSIBILITIES
It shall be the responsibility of pSiMedica or its designee to file,
obtain and maintain such licenses, registrations, listings, authorizations
and approvals as the European Authority or United States Authority or any
other applicable governmental entity may require to enable use of the
Sources as a Medical Device. QSA shall provide to pSiMedica as requested
or, at QSA's discretion directly to the regulatory authority (in order to
protect the proprietary nature of the information), all required
information in its possession necessary to assist pSiMedica in filing,
obtaining and maintaining all licenses, registrations, listings,
authorizations and approvals of any governmental entities necessary for
the use of Sources as a Medical Device and in order to seek marketing
authorization for the Medical Device.
17.2 QSA RESPONSIBILITIES
QSA shall be responsible for obtaining and maintaining all necessary
facility licenses, registrations, authorizations and approvals, other than
those required to market the Medical Device or use it in clinical trials,
which are necessary to develop, manufacture, handle, store, label,
package, dispose of, transport and ship Sources and radioactive materials
in the U.S., Germany, and other jurisdictions specified by pSiMedica.
17.3 GOVERNMENTAL 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 manufacturing, testing, storage and shipping of
Sources, including Process development operations, and to audit such
Facilities for compliance with applicable regulatory standards, and to
perform such other activity as such entity may be authorized to undertake.
QSA shall give pSiMedica prompt notice of any upcoming inspections or
audits by a government entity of the Facility or procedures and shall
provide pSiMedica with a written summary of such inspection or audit
following completion thereof. QSA agrees to use commercially reasonable
efforts to promptly rectify or resolve any deficiencies noted by a
government entity whether communicated orally, in a report or
correspondence or otherwise issued to QSA.
24
17.4 ACCESS TO THE FACILITY
pSiMedica shall have reasonable access to the Facility and procedures:
(i) at least once per calendar quarter and more frequently for good
cause, for the purpose of observing the Process development relating
to the Sources, and
(ii) no more frequently than semiannually (except for good cause) for the
purpose of auditing the Facility for compliance to applicable
regulatory requirements and standards relating to the Sources and
timely performance by QSA of its obligations hereunder.
After commencement of the Commercial Phase, pSiMedica shall, as mutually
agreed and no less frequently than semiannually (except for good cause),
be entitled to access to the Facility for the purpose of observing any
Process development or to audit the Facility for compliance with
specifications and other regulatory requirements. QSA shall provide access
to pSiMedica, on a continuing basis, to all QSA protocols, standard
operating procedures and manufacturing records, as is necessary or
relevant for the development, manufacture, handling, storage, labeling,
packaging, disposing, transportation and shipment of Sources, which may be
required in obtaining or maintaining licenses, registrations,
authorizations and regulatory authorization of the Medical Device. All
such information disclosed to pSiMedica or its employees or agents, shall
be deemed to be pSiMedica's Confidential Information as such term is
defined in this Agreement.
17.5 APPROVAL FOR MANUFACTURING CHANGES
QSA agrees that no changes will be made to any materials, Specifications,
Equipment, Hot Cell(s) or methods of production or testing the Sources,
without pSiMedica's prior written approval. Subsequent to such approval by
pSiMedica, QSA may then make such approved changes in manufacturing
procedures, so long as in any event:
(i) such changes are permitted by applicable government regulations and
the terms of any licenses, registrations, authorizations or
approvals previously granted by the applicable governmental entity
with respect to the Medical Device, and
(ii) pSiMedica receives copies of all documentation relating to such
approved changes.
If the changes require the additional license, registration, authorization
or approval of any applicable governmental entity in Europe, United States
or elsewhere, such changes may not be implemented until QSA receives
written notice that the governmental entity or entities has or have
authorized or approved the change. Each Party shall cooperate fully with
the other in preparing data and information for a submission requesting
prior authorization or approval of a change in materials, specifications,
equipment or methods of production or testing. However, where changes are
required to be made at the request of a regulatory body, pSiMedica shall
not withhold their agreement to such changes.
25
17.6 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 Sources
under this Agreement and which are required by the European Authority,
United States Authority or other applicable governmental entities and the
Parties shall confer with each other with respect to the best means to
comply with such requirements. QSA shall be responsible for implementing
and complying with any new or revised regulatory requirements arising
after the Effective Date relating to QSA's performance of this Agreement.
ARTICLE 18 - GENERAL INDEMNITY
18.1 HOLD HARMLESS
QSA and pSiMedica, as the case may be, shall indemnify and hold harmless
the other from and against any and all costs, claims, judgements or other
expenses, including reasonable attorney fees, arising as a result of
damages claimed by third parties, in tort, contract or other legal theory,
or arising as a result of its violation of any applicable law or
regulation, in each case occasioned by QSA's or pSiMedica's negligence or
willfulness or that of their respective employees or agents, in carrying
out their obligations hereunder.
18.2 INDEMNIFICATION PROCEDURES
A Party (the "Indemnitee") which intends to claim indemnification under
this Agreement 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 their respective 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 Indemnitor
shall have sole and exclusive control of the defense of any legal action,
including the choice and direction of any legal counsel. The Indemnittee
may not settle nor compromise any legal action without the written consent
of the Indemnitor The Indemnitee, and its respective directors, officers,
employees and agents shall cooperate 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.
26
18.3 SURVIVAL OF ARTICLE
This Article 18 shall survive the termination of this Agreement for any
reason including expiration of the term.
ARTICLE 19 - DISCLOSURE OF TECHNOLOGY
19.1 DISCLOSURE
Except as otherwise set out, it is agreed that disclosure of data,
information or technology by QSA or pSiMedica, 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 QSA or pSiMedica.
ARTICLE 20 - CONFIDENTIALITY
20.1 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 all technology
including Background Technology, pSiMedica Technology, Jointly Owned
Arising IP and know-how, data, processes, methods, techniques, formulas,
test data and other information disclosed to such Party by the other Party
whether or not it is identified as "Confidential Information" by the
disclosing Party (collectively "Confidential Information"). Each Party
shall necessarily be free to disclose its own Technology under the terms
of its own established process for the disclosure of its Confidential
Information. If either Party needs to disclose Confidential Information
pertaining to the manufacturing process covered by this Agreement to a
third Party then this shall be accommodated by the creation of a three way
Confidential Information disclosure agreement. This obligation of
confidentiality shall not apply to the extent that it can be established
by the Party in receipt of such Confidential 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.
27
Notwithstanding the foregoing, QSA and pSiMedica may both disclose
Confidential Information to an Affiliate or permitted assign provided that
the Affiliate or permitted assign is bound by confidentiality to the same
extent as QSA and pSiMedica hereunder. The Party disclosing Confidential
Information to such Affiliate or permitted assign shall be liable for any
unauthorized use or disclosure of the Confidential Information by the
Affiliate or permitted assign.
This Article shall survive termination or expiration of this Agreement in
accordance with its terms.
ARTICLE 21 - TERMINATION
21.1 TERMINATION FOR BREACH
This Agreement may be terminated by either Party in the event of a
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 thereof. Upon receipt of such Breach
Notice, the breaching Party shall have ninety (90) days to respond by
curing such breach. 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.
21.2 REMEDIES UPON TERMINATION BY QSA PURSUANT TO ARTICLES 21.1 OR 21.3
If QSA terminates this Agreement, under Articles, 21.1 or 21.3, QSA, in
addition to any claim for damages it may have, shall be entitled to:
(i) retain all amounts paid by pSiMedica to QSA prior to such
termination;
(ii) except for the Hot Cell(s), return to pSiMedica all the Equipment
which is owned by pSiMedica and in QSA's possession and for which
pSiMedica has paid all amounts due to QSA pursuant to this
Agreement, unless pSiMedica requests that QSA decommission the
Equipment by using the funds in the Escrow Account;
(iii) terminate all activities under this Agreement expeditiously so as to
minimize costs incurred by pSiMedica therefor;
(iv) deliver all completed and undelivered Sources to pSiMedica, or
destroy such Sources, as pSiMedica may elect.
(v) immediately upon such termination, except as provided elsewhere in
this agreement, terminate all licenses granted by QSA to pSiMedica
under this Agreement which rights shall revert back to QSA; and
28
(vi) where applicable receive from pSiMedica written confirmation that
the foregoing steps have been taken and that it has ceased using all
patents data, information, technology, trade secrets and other
intellectual property owned by QSA pursuant to this Agreement.
pSiMedica shall further reimburse QSA for all reimbursable costs and work
necessarily and properly incurred in relation to the orderly cessation of
the work and sums owing but not invoiced prior to the effective date of
any such termination by QSA under this Agreement. In addition, pSiMedica
will if QSA so opts, either promptly transfer title of the Hot Cell(s) to
QSA or allow the execution of the Decontamination and Decommissioning work
by using the funds in the Escrow Account, whereupon pSiMedica shall have
no further obligations under Article 6. 1.
21.3 BANKRUPTCY
Notwithstanding anything contained in this Agreement to the contrary, 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 which
are not stayed within sixty (60) days. Any assets jointly owned by the two
Parties including the Jointly Owned Arising IP shall become the property
of the Party not seeking such relief.
21.4 REMEDIES UPON TERMINATION BY PSIMEDICA PURSUANT TO ARTICLE 21.1 OR ARTICLE
21.3
If pSiMedica terminates this Agreement under Article 21.1 or under Article
21.3, or under any other provision hereof, pSiMedica, in addition to any
claim for damages it may have, shall be entitled to:
(i) within thirty (30) days of such termination at QSA's expense if
termination is caused by a breach of QSA's or at pSiMedica's if
termination is for any other reason, receive the Equipment and all
related materials, in its then current condition (subject to
decontamination);
(ii) exercise the option whether the Hot Cell(s) shall be returned to
pSiMedica by QSA or whether they shall be decontaminated and
decommissioned by QSA by using the funds in the Escrow Account;
(iii) receive all completed Sources which have been ordered but not
delivered;
(iv) immediately upon such termination, terminate all licenses granted by
pSiMedica to QSA under this Agreement which rights shall revert back
to pSiMedica and QSA shall then destroy all Sources pSiMedica elects
not to acquire; and
29
(v) receive from QSA written confirmation that the foregoing steps have
been taken and that it has ceased using all patents data,
information, technology, trade secrets and other intellectual
property owned by pSiMedica pursuant to this Agreement.
If pSiMedica terminates this Agreement, pSiMedica shall reimburse QSA for
all reimbursable costs and work necessarily and properly incurred in
relation to the orderly cessation of the work and sums owing but not
invoiced prior to the effective date of any such termination by pSiMedica
under this Agreement. In addition, pSiMedica will if QSA so opts, either
promptly transfer title of the Hot Cell(s) to QSA or allow the execution
of the Decontamination and Decommissioning work by using the funds in the
Escrow Account, whereupon pSiMedica shall have no further obligations
under Article 6. 1.
21.5 CONSEQUENCES OF TERMINATION OR EXPIRATION
Notwithstanding expiration or termination of this Agreement, the
obligations of the Parties under Articles 21 shall survive termination of
this Agreement.
ARTICLE 22 - NOTICES
22.1 Within thirty (30) days after execution of this Agreement, the Parties
shall each designate a Project Manager, who shall be responsible for
coordinating communication and monitoring performance under this
Agreement. All references in this Agreement to changes to the Schedules
shall be automatically approved if agreed in writing by both Parties
Project Managers.
22.2 Any notice to be sent to a Party hereunder except with regard to changes
to the Schedules hereto shall be forwarded to:
22.3 QSA at: AEA TECHNOLOGY-QSA, GMBH
Gieselweg 1
D-38110, Braunschweig
GERMANY
Attention: Dr. Rainer Lambrich
PSiMedica at: pSiMedica Ltd
Malvern Hills Science Park
Geraldine Road
Malvem, Worcestershire, WR14 3SZ
UNITED KINGDOM
Attention: Dr. Roger Aston
30
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, overnight
courier or electronic facsimile confirmed by registered mail.
ARTICLE 23 - DISCLAIMER OF CONSEQUENTIAL DAMAGES
23.1 DISCLAIMER
In no event shall either Party be liable to the other for indirect,
contingent, incidental, special or consequential damages, including, but
not limited to, any claim for damages based on lost profits, cost of
capital, loss of business opportunity or loss of time.
ARTICLE 24 - ASSIGNMENT
24.1 NO ASSIGNMENT
This Agreement shall endure to the benefit of and shall be binding upon
the heirs, executors, administrators, successors and permitted assigns of
the Parties. Neither QSA nor pSiMedica shall assign any portion of this
Agreement without the written approval of the other Party, which approval
shall not be unreasonably withheld. However, either Party has the right to
assign this agreement to an Affiliate, but in such case shall remain
liable to the other Party for the performance of its Affiliate and shall
indemnify the other Party and hold it harmless from and against all costs,
claims, judgements and other expenses arising from the Affiliate's
performance or failure of performance.
QSA shall be entitled to subcontract to third parties any of its
obligations set out in this Agreement in order to carry out its
obligations hereunder; provided, however, that QSA may not subcontract any
obligation in this Agreement unless such subcontractor shall agree to be
bound by all of the relevant provisions hereof. QSA shall remain
responsible for the performance of its subcontractors and shall indemnify
pSiMedica and hold it harmless from and against any and all costs, claims,
judgments or other expenses arising from any subcontractor's performance
or failure of performance.
ARTICLE 25 - COMPLIANCE
25.1 COMPLIANCE WITH LAWS
This Agreement shall be carried out in compliance with all relevant laws,
bylaws, rules, regulations and orders of government or manifestations
thereof of Germany, the European Union and the United States.
31
ARTICLE 26 - NON-WAIVER
26.1 NON-WAIVER OF RIGHTS
Failure by either Party to enforce at any time any of the provisions of
this Agreement shall not be construed as a waiver of its rights hereunder.
Any waiver of a breach of any provision hereof shall not affect either
Party's rights in the event of any additional breach.
ARTICLE 27 - FORCE MAJEURE
27.1 FORCE MAJEURE
Neither Party shall be liable to the other for loss or damage 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. If QSA is the Party
affected by the Force Majeure event, QSA agrees that it will resume
production of Sources as soon as practicable thereafter. For such time as
QSA is affected by an event of Force Majeure, PSiMedica is relieved from
its purchase obligations under this Agreement which purchase commitments
shall be adjusted accordingly on a pro rated annual basis. "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, 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
not existing on the Effective Date, failure of unaffiliated 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, beyond the commercially
reasonable control of such Party.
ARTICLE 28 - INSURANCE
28.1 PSIMEDICA INSURANCE
From the start of the commercial phase of this Agreement and for a period
of four years after the expiration or other termination hereof, pSiMedica
shall maintain in force and effect product liability insurance issued by a
reputable insurance company with a rating reasonably satisfactory to QSA.
Such insurance shall (a) insure against Damages resulting from or caused
by (or claimed to be resulting from or caused by) the operation or use of
any Medical Devices marketed or distributed by pSiMedica, and (b) shall
have coverage limits of not less than U.S. $8,000,000 per occurrence and
U.S. $8,000,000 in the aggregate. Within 15 days after the execution of
the Commercial Phase of this Agreement, pSiMedica will deliver to QSA
copies of all policies effecting such insurance (in English) with a
certificate (in English) of pSiMedica's insurance broker stating that all
premiums then due have been paid.
32
It is understood that pSiMedica shall establish separate insurance cover
for the risks associated with the period of clinical trials for each
individual clinical trial. pSiMedica will deliver to QSA copies of all
policies effecting such insurance (in English) with a certificate (in
English) of pSiMedica's insurance broker stating that all premiums then
due have been paid.
28.2 QSA INSURANCE
QSA agrees, at QSA's expense, to maintain general liability, business
interruption (for at least $2 million) and property and casualty insurance
covering loss or damage to:
(i) the Facility;
(ii) any asset owned by pSiMedica in the possession of QSA under this
Agreement, including the Hot Cell(s) and Equipment; and
(iii) QSA's facility located at Braunschweig, Germany, as the case may be.
Such insurance policy shall designate pSiMedica as loss payee in the event
of any loss or damage involving any asset owned by pSiMedica and shall
name pSiMedica as an additional insured. QSA agrees that such insurance
shall be replacement value insurance for all property owned by pSiMedica.
QSA shall, upon request, provide to pSiMedica a certificate of insurance
designating pSiMedica as loss payee in event of any loss or damage covered
by sub-clause (ii) of this Article, provided that any proceeds so received
as a result of less than a total loss shall be used to repair such damaged
or destroyed assets, including, but not limited to, the Hot Cell(s) and
the Equipment. Any insurance proceeds held by QSA pursuant to this Article
shall be used to repair or replace such damaged Facility and QSA shall
give pSiMedica thirty (30) days advance notice of any termination or
cancellation of such coverage. This Article shall survive termination of
this Agreement with respect to sub-clause (ii) of the first sentence of
this Article.
In addition, during the Term of the Commercial Phase of this Agreement and
for a period of four years after the expiration or other termination
hereof, QSA shall maintain in force and effect product liability insurance
issued by a reputable insurance company with a rating reasonably
satisfactory to pSiMedica. Such insurance shall (a) include coverage
insuring against Damages resulting from or caused by (or claimed to be
resulting from or caused by) the operation or use of any Source shipped or
repaired by QSA (b) shall have coverage limits of not less than U.S.
$8,000,000 per occurrence and U.S. $8,000,000 in the aggregate, and shall
name pSiMedica as an additional insured. Within 15 days after the
execution of the Commercial Phase of this Agreement, QSA will deliver to
pSiMedica copies of all policies effecting such insurance (in English)
with a certificate (in English) of QSA's insurance broker stating that all
premiums then due have been paid.
33
ARTICLE 29 SEVERABILITY
29.1 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 so long as the economic or legal substance of the Agreement or
transactions contemplated herein are not affected in any manner materially
adverse to any Party. 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 30 GENERAL
30.1 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.
30.2 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 dissemination. The
Parties agree that they will use reasonable efforts to coordinate the
initial announcement or press release relating to the existence of this
Agreement.
30.3 EXPORT CONTROL
The Parties understand that materials and information resulting from the
performance of this Agreement may be subject to export control laws and
that each Party is responsible for its own compliance with such laws.
pSiMedica agrees that the cost of exporting Sources from Germany at its
request shall be the responsibility of pSiMedica.
34
30.4 DISPUTE RESOLUTION
(i) In the event that, at any time during the term of this Agreement, a
disagreement, dispute, controversy or claim should arise relating to
scientific or technical issues in connection with QSA's performance
under this Agreement, the Parties will attempt in good faith to
resolve their differences for sixty (60) days. If, after sixty (60)
days, the Parties are unable to resolve such dispute, the Parties
shall refer the matter to a third Party consultant with expertise in
the scientific or technical area of dispute for sixty (60) days. In
the event such consultant is unable to work out a resolution of the
issue with the Parties, the Parties shall within 30 days submit the
matter to binding arbitration in Frankfurt, Germany to be undertaken
pursuant to the applicable rules of the London Court of
International Arbitration.
(ii) In the event that, at any time during the term of this Agreement, a
disagreement, dispute, controversy or claim should arise out of or
relating to the interpretation of or performance under this
Agreement, or the breach, or invalidity thereof other than a dispute
relating to scientific or technical issues in connection with QSA's
performance under this Agreement covered by Article 30.4 sub-clause
(i) above, the Parties will attempt in good faith to resolve their
differences by referring the matter to the Chief Executive Officers
of the Parties (or their designees) for sixty (60) days, following
which if the matter is not resolved it will be submitted to
alternative dispute resolution in Frankfurt, Germany to be
undertaken pursuant to the applicable rules of the London Court of
International Arbitration.
(iii) The dispute resolution tribunal shall be composed of three
arbitrators. The language of the arbitration shall be English. Under
the LCIA Rules which are deemed to be incorporated by reference into
this Agreement, the arbitrators shall resolve any dispute arising
out of or in connection with this Agreement, including any questions
regarding its existence, validity or termination.
30.5 ESSENCE
Time is of the essence in this agreement.
ARTICLE 31 - APPLICABLE LAW
31.1 APPLICABLE LAW
This Agreement shall be governed and construed in accordance with the laws
of Germany. The Convention on the International Sale of Goods of April 11,
1980 (CISG) and the German Law transforming the CISG into national law
shall not apply.
35
IN WITNESS WHEREOF the Parties hereto have executed this Agreement as of the
date first above written.
AEA TECHNOLOGY QSA GMBH
By: /s/Ranier Lambrich
------------------------------------
Dr. Rainer Lambrich
Geschaftsfuhrer
PSIMEDICA LTD
By: /s/Roger Brimblecombe
------------------------------------
Dr. Roger Brimblecombe
Chairman
36
SCHEDULE A DEVELOPMENT PHASE
This schedule is subject to any requirement contained in schedules B, C and D.
Any changes to such requirements will alter the provisions of schedule A.
At the Effective Date the ongoing development phase continues to optimise the
production of irradiated P-32 BioSilicon(TM) for animal and potential human
trials and the development of automation to the handling processes necessary to
produce the finished Sources.
The Development Phase has two key milestones
1. Pilot plant development for supply of circa 8 patient doses into a
Phase IIa human clinical trial expected to commence May 2004.
2. Main plant development with process scale up to deliver [***] into a
Phase IIb human clinical trial expected to commence [***]. Design capacity for
commercial production - [***].
The initial development programme will indicate the process by which sources
will be manufactured viz) method of slurry creation, or dry powder dispensing,
and sterilization method. The time frame for this is estimated to be by end
March 2004.
Flexibility to react to pSiMedica requirements is an important concept in the
Development Phase and at the Effective Date work was also being defined to
develop a Source dose-vial containment, shielding and Source transport
container.
Progress of the Development Phase projects is disseminated via monthly reports
and changes/additions to the programmes are actioned after receipt of written
instructions from PSiMedica.
Additional development activities outside of the scope of the initial
development programme and provision of the Pilot Plant facility will be agreed
under protocol by both parties and billed at the following contract rates
Facility Programme billing rates:
[***]
37
SCHEDULE B FACILITY DESCRIPTION
[*** five pages excluded ***]
38
SCHEDULE C PRODUCT DESCRIPTION (FOR PHASE IIA PRODUCT)
32P BioSilicon 20um High P is a source component consisting of 20um particles of
acid treated Silicon containing Phosphorus-32.
The device will be provided `for single use only' as a dry powder for use in
interstitial brachytherapy. It is supplied as a sterile powder in 10ml
borosilicate glass vials with a 20mm rubber stopper and aluminium overseal. The
glass vial is contained for transportation within a lead-shielded Perspex "vial
carrier".
Specific activity of P-32 BioSilicon 20um High P at reference date will be 1.4
+/- 0.1 MBq per mg.
Nominal activity: Each vial will contain 250 +/- 25 MBq of P-32 BioSilicon 20um
High P.
Prior to use the device will be reconstituted in an injectable suspending
aqueous formulation (known as FM27v2) at up to 50 mg/ml BioSilicon
microparticles.
It is anticipated that the Source will be a component of a Device kit that is
approved for the delivery of patient doses.
First clinical trials will follow a low dose range strategy of ~ 4 MBq per ml of
tumour. The 32P-BioSilicon(TM) microparticles will be administered
interstitially using a specially designed shielded syringe, which is under
development. This will minimise the possibility of environmental contamination
with radionuclide during the injection process, ensure operator safety and allow
site directed delivery using assisting techniques such as ultrasound or
tomography.
Radionuclide purity:
32P BioSilicon 20um High P is nuclear reactor produced by the neutron
bombardment of 31P. At the time of calibration it contains not less than 99%
Phosphorus 32
Radiochemical purity: >95%
Chemical purity:
32P BioSilicon 20um High P is tested for the following metals, Na, Mg, Al, K,
Ca, Cr, Mn, Fe, Ni, Cu (also Mo & Co) and contains below 10 ppm of each
impurities.
It is recognised by both Parties that the product details may change as the
Development programme progresses. All changes will be as a result of mutual
agreement and confirmed in writing, between the parties.
39
SCHEDULE D SOURCE SPECIFICATIONS
At the Effective Date, the final specification and presentation of the Source(s)
has not been completely developed, however, the fundamental product details and
description of the said specification are understood, and are detailed in
Schedule C.
In addition, during the period of the Development Phase covered in Article 4,
pSiMedica may request alterations to the specifications in order to meet the
needs of:
- Product Improvement
- Product development difficulties
- Market changes
- Business strategy
A draft specification agreed by both Parties is incorporated into this Schedule
D. Changes to the specifications must be agreed in writing between the two
Parties and where justified, revisions to the Commercial Phase terms will be
allowed.
40
- --------------------------------------------------------------------------------
AEA TECHNOLOGY Specification [LOGO]
QSA GMBH Specification for P-32 BioSilicon 20umHigh P AEA TECHNOLOGY
BRAUNSCHWEIG Dokumentnummer: QSA
- --------------------------------------------------------------------------------
DRAFT SPECIFICATION:
SPECIFICATION FOR P-32 BIOSILICON 20UMHIGH P
DRAFT 1
QS-DOC. NO.:
- --------------------------------------------------------------------------------
Erstellt:
Name, Vorname / Funktion : Th
Datum :
Unterschrift :
- --------------------------------------------------------------------------------
Gepruft:
Name, Vorname / Funktion :
Datum :
Unterschrift :
- --------------------------------------------------------------------------------
Genehmigt
Name, Vorname / Funktion :
Datum :
Unterschrift: :
- --------------------------------------------------------------------------------
Uberprufungsintervall: alle 2 Jahre
Besonderheiten: keine
41
- --------------------------------------------------------------------------------
AEA TECHNOLOGY Specification [LOGO]
QSA GMBH Specification for P-32 BioSilicon 20umHigh P AEA TECHNOLOGY
BRAUNSCHWEIG Dokumentnummer: QSA
- --------------------------------------------------------------------------------
- ----------------------------------------------------------------------------------------------
1. MAT. NO. [Psi code No.]
- ----------------------------------------------------------------------------------------------
2. DISTRIBUTOR
- ----------------------------------------------------------------------------------------------
3. CODE PBSB.....
- ----------------------------------------------------------------------------------------------
4. PRODUCT NAME (32P)BioSilicon 20um High P
COMPANY DISTRIBUTOR PsiMedica
- ----------------------------------------------------------------------------------------------
5. COMMERCIAL DESIGNATION --
CAS-NO.
- ----------------------------------------------------------------------------------------------
6. DESCRIPTION TARGET
- ----------------------------------------------------------------------------------------------
6.1 ACID TREATED SILICON CONTAINIG --
[32P]PHOSPHORUS
DRY STERILE POWDER
IN VIALS WITH PUNCTURE STOPPER AND CRIMPED CAPS
- ----------------------------------------------------------------------------------------------
7. CHEMICAL / PHYSICAL PROPERTIES / METHODS TARGET
- ----------------------------------------------------------------------------------------------
7.1 IDENTITY P-32 / LIQUID SCINTILLATION COUNTING Beta max. energy not greater
than 1.7 1MeV
- ----------------------------------------------------------------------------------------------
7.2 y-emitting impurities / y-spectrometry P-32 > 99 %
AT REFERENCE DATE (RD) Impurities
< 1%
- ----------------------------------------------------------------------------------------------
7.3 SPECIFIC ACTIVITY P-32 AT RD
LIQUID SCINTILLATION COUNTING (1.4 +/- 0.1) MBq/mg
AFTER DISSOLVING AND DILUTION
- ----------------------------------------------------------------------------------------------
7.4 (mass or volume of formulant per vial) Tbd n.n.
- ----------------------------------------------------------------------------------------------
7.5 ACTIVITY AT RD / IONISATION CHAMBER MEASUREMENT (250 +/- 25) MBq
- ----------------------------------------------------------------------------------------------
7.6 Chemical purity / (Tbd Psi) Tbd by PSi
- ----------------------------------------------------------------------------------------------
7.7 RADIOCHEMICAL PURITY / PER SE > 95%
- ----------------------------------------------------------------------------------------------
42
- ----------------------------------------------------------------------------------------------
8. OTHER REQUIREMENTS
- ----------------------------------------------------------------------------------------------
9. CERTIFICATE Batch No.;.... [batch code system tbd by PSi]
- ----------------------------------------------------------------------------------------------
10. SAFETY DATA SHEET PURSUANT TO --
91/155/EWG
- ----------------------------------------------------------------------------------------------
11. SHIPPING TERMS Shielded
- ----------------------------------------------------------------------------------------------
12. STORAGE TERMS Shielded
- ----------------------------------------------------------------------------------------------
13. REFERENCE DATE AND TIME Date (Day, Month, Year),
LABELLING 12:00 (Singapore local time)
- ----------------------------------------------------------------------------------------------
14. SHELF- LIFE Reference date +/- 2 days
- ----------------------------------------------------------------------------------------------
15. PRODUCT PACKAGING P6 injection vial with puncture stopper
and crimped caps
- ----------------------------------------------------------------------------------------------
16. WRAPPING / SHIPPING PACKAGING Typ A Shipping Packaging
- ----------------------------------------------------------------------------------------------
17. REDEMPTION/ DISPOSAL Product: Hazardous Waste
- ----------------------------------------------------------------------------------------------
18. MISCELLANEOUS --
- ----------------------------------------------------------------------------------------------
43
SCHEDULE E PRICING
In accordance with Article 9.3, prior to the commencement of the Commercial
Phase, the Parties shall agree the price that shall be paid by pSiMedica for
each Source that QSA produces to Specification. [***].
At the Effective Date QSA is unable to provide definitive pricing schedules that
will be relevant to the supply of sources during the Commercial Phase, however,
good faith indications of the prices will be confirmed at the end of the
relevant portion of the Development Phase and prior to the commencement of the
Commercial Phase. The definitive pricing schedules will be communicated via an
amended Schedule E.
It is anticipated that pricing will vary by required batch size and that the
price schedules will reflect this fact. Source prices will be cited for
different order quantities, however, the prices will be dictated by the
effective number of Sources demanded per batch. Both Parties recognise that the
Facility will be designed to cope with a maximum Source throughput (Sources per
year) that will be agreed before the end of the Development Phase.
[***]