CONFIDENTIAL MATERIALS OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE OMISSIONS.
CONFIDENTIAL
MATERIALS OMITTED AND FILED SEPARATELY WITH
THE
SECURITIES
AND EXCHANGE COMMISSION. ASTERISKS DENOTE OMISSIONS.
Contract
Manufacturing Agreement (Hereinafter this “Agreement”)
dated
|
January
08th, 2007
|
b
e
t w e e n
|
HOLOPACK
|
Xxxxxxxxxxxxxxxxxx
XxxX
Xxxxxxxxxxxxx
00000
Xxxxxxxx-Xxxxxx 1
-
hereunder referred to as -SUPPLIER-
a
n
d
|
CYTOGEN
CORPORATION
|
|
000
Xxxxxxx Xxxx Xxxx
|
|
Xxxxxxxxx,
Xxx Xxxxxx 00000 XXX
|
-
hereunder referred to as CUSTOMER -
In
consideration of the mutual covenants and promises contained herein, and
for
other good and valuable consideration, the receipt and sufficiency of which
hereby are acknowledged, SUPPLIER and CUSTOMER, intending to be legally bound,
agree as follows:
Page
1
from 24
§
1 Purpose
and Subject of this Agreement
The
purpose and subject of this Agreement is the manufacture of the products
listed
in Appendix 1 of this Agreement ("Contract Products").
Simultaneously
with, and as a condition to the effectiveness hereof, the parties are executing
a Quality Agreement (the “Quality Agreement”) with respect to the Contract
Products. In the event of an inconsistency of this Agreement and the
Quality Agreement, this (Contract Manufacturing) Agreement shall
prevail.
§
2 Manufacture
of the Contract Products
1.
|
SUPPLIER
agrees with CUSTOMER to manufacture and fill the Contract Products
listed
in Appendix 1, with the "bottelpack" process according to the
manufacturing, quality control, packaging and other directions
issued by
CUSTOMER and appended to this Agreement as Appendix 2 and 3 and
7.
|
CUSTOMER
is responsible for the first release to bring Contract Products to the market
according to § 5 MPG (a copy of which is attached to this Agreement) and to
fulfil all requirements according to § 6ff.MPG.
CUSTOMER
is manufacturer according to § 3,15 MPG
2.
|
During
the manufacture of the Contract Products, SUPPLIER will duly consider
the
recognised pharmaceutical rules and applicable legal regulations
in
Germany. SUPPLIER acknowledges and agrees that: (i) the Contract
Products
are to be distributed in the United States (the “Territory”); and (ii)
SUPPLIER’s manufacture of the Contract Products shall comply with
applicable pharmaceutical laws and regulations of the United States,
including without limitation current good manufacturing practices
(“cGMP”)
as promulgated under United States Federal Food, Drug and Cosmetic
Act.
|
3.
|
CUSTOMER
assumes the responsibility for the manufacturing, quality control,
packaging and other directions supplied by it, including the product
specifications according to Appendix 2, 3 and 7 of this Agreement,
and for
all properties of the Contract Products resulting from CUSTOMER’s
instructions. The same shall apply in the event SUPPLIER manufactures
Contract Products according to manufacturing, quality control and
packaging directions, which have been developed in collaboration
with
CUSTOMER.
|
The
manufacturing and quality control directions as well as other regulations
supplied by CUSTOMER must be in agreement with the prevailing industry standards
and applicable laws, rules, regulations and directives in the Territory and
Germany (including, without limitation current good manufacturing practices,
WHO).
If
amendments to these regulations are required, these regulations must be replaced
by a supplement to this Agreement. The new regulation becomes valid when
it has
been signed by both parties to this Agreement.
4.
|
SUPPLIER
is only responsible for fulfilment of its obligations under this
contract.
Besides that CUSTOMER assumes responsibility for the fulfilment
of its
obligations as manufacturer according to §3,15
MPG.
|
Page
2
from 24
5.
|
Prices
and payment conditions shall be according to Appendix
IX.
|
6.
|
In
the event that SUPPLIER determines to discontinue the manufacture
of
Contract Products, SUPPLIER shall give CUSTOMER prompt notice of
such
determination.
|
§
3 Supply
of Starting and Secondary Packaging Materials, Release for
Manufacture
1.
|
SUPPLIER
shall provide the starting materials required and the packing materials
according to Appendix 4.
|
2.
|
CUSTOMER
shall provide the starting materials required and the packaging
materials
according to Appendix 5 free of charge at the latest [**] prior
to the
start of production.
|
3.
|
SUPPLIER
shall inspect all starting materials, to be provided by it for
quality
according to the quality control directions in Appendix 3, and
shall
release conforming materials for
manufacture.
|
SUPPLIER
shall inspect all secondary packaging material, to be provided by it for
suitability, and sends samples of each delivery to the CUSTOMER and CUSTOMER
shall release conforming materials for manufacture.
4.
|
CUSTOMER
shall supply SUPPLIER with: (i) certificates of analysis for all
starting
materials supplied by CUSTOMER according to Appendix 5, if any;
(ii)
releases for manufacture for all starting materials supplied by
CUSTOMER,
if any. CUSTOMER shall provide to the SUPPLIER a sufficient amount
of the
reference standards required for identity, content and purity tests
of the
active substances for the current order
campaign.
|
The
packaging material supplied by CUSTOMER will be checked for quality and released
for manufacture by the CUSTOMER. SUPPLIER shall only check the supplied
packaging material for identity.
§
4 Documentation,
Samples, Retain Samples, Responsible Persons
1.
|
SUPPLIER
will supply to CUSTOMER a report (production protocol or batch
record) for
each lot manufactured as the documentation for the authorities,
containing
the following:
|
|
-
|
the
description and mode of
application,
|
|
-
|
the
lot identification or inspection number of the starting materials
used,
|
|
-
|
the
manufacturing date and the lot
number,
|
|
-
|
a
statement on the amount of medication manufactured in one lot and
its
ingredients during the individual processing
steps,
|
|
-
|
the
results of the in-process
inspections,
|
Page
3
from 24
|
-
|
the
confirmation of proper manufacture according to the manufacturing
instruction signed with the names of the persons responsible for
the
individual processing steps,
|
|
-
|
special
observations during the
manufacture,
|
|
-
|
information
on the kind of containers, outer coverings, and other packaging
materials
used, and
|
|
-
|
information
on the kind and number of lot
samples.
|
The
parties agree that the production protocol may refer to specific information
in
other documents.
2.
|
SUPPLIER
shall have the right to vary the lot size within validated
parameters. Any lot size outside of validated parameters shall
require the written consent of CUSTOMER. SUPPLIER shall file the
documentation and retain samples of each medication for at least
[**]
longer than the expiration date of the contract product or longer
if
required by law and
SUPPLIER shall make such materials available as soon as reasonably
practicable to CUSTOMER after SUPPLIER’s receipt of CUSTOMER’s written
request for access to such records
and/or
samples.
|
3.
|
SUPPLIER
will furnish to CUSTOMER a summary of all the data in the manufacturing
protocol which is required to evaluate the contract product (according
to
Appendix 6).
|
4.
|
The
responsible persons are listed in Appendix 8. Such responsible
persons will coordinate work carried out hereunder with the other
party’s
responsible persons. The responsible persons of the respective
parties shall be the day-to-day contacts between the parties hereto
and
shall receive copies of all written correspondence exchanged between
the
parties with respect to the designated work. In the event
either party identifies an issue relating to the manufacture, quality,
delivery, customer service, or the like with respect to contract
product,
the applicable responsible persons of each party shall promptly
confer to
resolve such issue. If a responsible person leaves the employ
of a party, an equally competent, acceptable, responsible person
shall be
assigned by such party.
|
§
5 Primary
Packing Materials, Labelling, Packing, Shipping
1.
|
As
packing material coming in direct contact with the product manufactured
by
SUPPLIER (primary packing material), SUPPLIER will use only materials
by
manufacturers which have been accepted in writing by
CUSTOMER. SUPPLIER shall conduct an identity check of all
primary packing material to be used in the packaging of the Contract
Products. Such identity check shall be in accordance with the
quality control directions in Appendix
3.
|
2.
|
Packing
of the "Contract Products" is made according to the packing directions
defined in Appendix 7. CUSTOMER assumes the responsibility for
the
suitability of the labelling and packing materials (primary and
secondary
packing materials) for packing and labelling of the Contract Products,
including labels which might be supplied by SUPPLIER. SUPPLIER
does not
incur liability for the effect of these materials on the contract
product.
|
Page
4
from 24
3.
|
If
CUSTOMER requires inspections exceeding the specifications in § 5.1 of
this Agreement, a separate agreement in writing between the parties
describing such inspections and cost thereof shall be
required.
|
4.
|
SUPPLIER
shall ship and deliver the Contract Products [**]. SUPPLIER
’s facility located
in
Xxxxxxxx-Laufen/Untergröningen. SUPPLIER
shall
arrange and organize shipment on behalf of the CUSTOMER under controlled
temperature conditions, without prejudice to CUSTOMERS responsibility
for
the Transport [**].
|
§
6 Quality
Control, Release from Manufacture
Quality
control, in accordance with the quality control directions set forth in APPENDIX
3, and the Quality Agreement is the responsibility of SUPPLIER.
Release
from manufacture and for the market for the Contract Products manufactured
by
SUPPLIER is the responsibility of CUSTOMER.
§
7 Storage
1.
|
The
starting materials supplied by CUSTOMER, if any, and the Contract
Products
manufactured by SUPPLIER shall be stored by SUPPLIER between [**]
without
further protective measures.
|
2.
|
If
the starting materials or Contract Products cannot be stored properly
under these conditions or if further storage measures are required,
especially protective measures, CUSTOMER must inform SUPPLIER to
this
effect in writing.
|
3.
|
If
special storage conditions according to § 7.2 of this Agreement require
additional investment, e. g. air conditioning, external storage
etc.,
CUSTOMER will cover the reasonable costs incurred by SUPPLIER in
connection therewith.
|
§
8 Marketing
of the Contract Product
1.
|
CUSTOMER
shall market the Contract Products on its own
behalf.
|
2.
|
CUSTOMER
assumes the responsibility for the selling of the Contract Products
including the labelling thereof, including without limitation supplements
to packing, instruction sheets, and
labels.
|
3.
|
CUSTOMER
is the responsible person for putting on the market (as contemplated
by §
5 MPG) and is further responsible for obtaining the right to affix
the
XX-xxxx and shall be responsible for the manner of use of the
XX-xxxx.
|
4.
|
CUSTOMER
shall have the appropriate qualified personnel in accordance with
§§ 30
and 31 MPG.
|
Page
5
from 24
§
9 Confidentiality
“Confidential
Information” within the meaning of this Agreement shall mean such written, oral,
or other, tangible or non-tangible notices, disclosures, materials, and other
information of the Parties, their Affiliates, or other third parties, provided
to one Party or its Affilliates by the other Party or its Affilliates or
which
has become known to the other Party under or on the occasion of this Agreement
or the preceding Mutual Nondisclosure Agreement dated September 1,
2006.
Such
information shall not be Confidential Information to the extent that it can
be
proved by demonstration of competent written records by the Recipient that
such
information:
|
a.
|
was
already known to the Recipient at the time of disclosure and was
not
acquired directly or indirectly from the Discloser or any of its
Affiliates or from any other Party in breach of an agreement of
confidentiality to the Discloser or any of its
Affiliates;
|
|
b.
|
at
the time of disclosure was generally known or easily
accessible;
|
|
c.
|
after
the time of disclosure became generally known or easily accessible,
except
by breach of this Agreement or by breach by any third party being
under an
obligation of confidentiality to the Discloser or any of its
Affiliates;
|
|
d.
|
is
disclosed to the Recipient by a third party and was not acquired
directly
or indirectly from the Discloser or its Affiliates or from any
other party
in breach of an agreement of confidentiality to Discloser or any
of its
Affiliates; or
|
|
e.
|
information,
which is or was developed by the Recipient independently of receipt
hereunder;
|
|
f.
|
Information
expressly marked by the Discloser as non
confidential.
|
Confidential
Information shall include the terms of this Agreement.
The
Parties agree to keep all Confidential Information strictly secret and not
to
disclose, provide, transfer or otherwise make available all or any part of
such
Confidential Information to third parties, except to the extent necessary
for
the performance of this Agreement to their respective directors, officers,
employees, insurers and / or attorneys, and Affiliates, provided that the
receiving Party shall ensure, that the respective directors, officers, employees
and / or attorneys their respective Affiliates, agree to abide by the terms
of
this Agreement or an equally or more restrictive confidentiality obligation
prior to receiving any Confidential Information.
Notwithstanding
anything set forth herein to the contrary, this § 9 shall not prohibit the
receiving party from disclosing confidential or proprietary information of
the
disclosing party that is required to be disclosed by the receiving party
to
comply with applicable laws, including without limitation the rules and
regulations promulgated by the Food and Drug Administration or the United
States
Securities and Exchange Commission, or to comply with governmental regulations,
provided that the receiving party provides prior written notice of such
disclosure to the disclosing party and takes reasonable and lawful actions
to
avoid and/or minimize the degree of such disclosure.
Page
6
from 24
§
10 Complaints
1.
|
SUPPLIER
shall manufacture and fill the Contract Products listed in Appendix
1,
with the [**] process according to the manufacturing, quality
control, packaging and other directions issued by CUSTOMER and
appended to
this Agreement as Appendix 2 and 3 and
7.
|
The
terms
and condition of this agreement and/or its Annexes shall in no way be considered
as an implied warranty or guarantee. However, even where such warranty or
guarantee should be expressly declared within or in connection with this
Agreement, it shall be valid only under the provision and to the extent,
that it
shall in no way restrict or exclude SUPPLIER’s limitation of liability according
to § § 11.1 to 11.3.
2.
|
CUSTOMER
is obligated to inspect the Contract Products promptly upon receipt
and to
present complaints to SUPPLIER without delay in writing, stating
the
reasons as well as the invoice, order, and lot
numbers.
|
Obvious
faults must be complained on within [**] of the shipment by CUSTOMER, and
hidden
defects must be complained on within [**] from the date they have been found.
Shipments which are not complained on in time according to the specifications
of
this clause shall be deemed faultless.
3.
|
The
limitation period for all claims related to defects of the Contract
Products is [**], beginning with delivery of the Contract Products.
Statements on minimum expiry dates are based on stability experiments
of
CUSTOMER and have no influence on the warranty period, and especially
do
not extend it.
|
4.
|
If
SUPPLIER has manufactured faulty Contract Products
[**].
|
Any
further warranty (gesetzliche Gewahrleistung) is excluded.
§
11 Liability
1.
|
SUPPLIER
is liable to CUSTOMER
for [**].
|
2.
|
SUPPLIER
has concluded a company liability insurance covering personal damages
up
to [**], with maximum coverage for a single incidence.
[**].
|
The
extent of the liability for damages of SUPPLIER is limited according to § 11.1
and § 11.2 of this agreement to those amounts covered by the company liability
insurance of SUPPLIER. CUSTOMER declares a waiver of recourse for all exceeding
claims.
Page
7
from 24
3.
|
The
limitation of liability under § 11.2 shall not apply in cases of [**] of
the obligations under this
Agreement.
|
4.
|
If
third parties claim damages from SUPPLIER, CUSTOMER will indemnify
and
hold SUPPLIER harmless from such claims inasmuch as SUPPLIER is
not liable
for such damages on the basis of § 11.1 and § 11.3 of this
agreement.
|
5.
|
As
a manufacturer of medical products according to §3,15 MPG, CUSTOMER has
secured a insurance coverage for product liability with limits
of [**] (US
Dollars) and guarantees to maintain this insurance for the duration
of
this agreement.
|
§
12 Property,
Insurance, Transport
1.
|
The
starting materials and other materials supplied by CUSTOMER remain
its
sole property until they are processed by SUPPLIER in the manufacture
of
Contract Products. SUPPLIER agrees to inform CUSTOMER without delay
of
legal execution against these materials and to inform third parties
of the
property rights of CUSTOMER.
|
2.
|
The
parties agree that SUPPLIER gains co-ownership of the starting
materials
and other materials or the contract product by processing the starting
materials and other materials, to the extent of the value of the
processing and the starting materials and other materials possibly
supplied by SUPPLIER in relation to the value of the finished contract
product. The co-ownership of SUPPLIER remains in force until full
payment
of all amounts due SUPPLIER from CUSTOMER hereunder. However, CUSTOMER
is
entitled to sell the contract product in the course of its regular
business operation.
|
3.
|
CUSTOMER
is responsible to insure all delivered goods according to Appendix
5 and
the manufactured Contract Products, as long as they are at SUPPLIER’s
premises, against fire, theft and extended coverage
perils.
|
4.
|
CUSTOMER
is responsible for suitable transport conditions for the starting
materials and other materials supplied according to this Agreement,
and
the Contract Products manufactured of it by SUPPLIER. The assumption
of
further responsibilities by SUPPLIER requires special agreement
and
adjustment of costs.
|
§
13 Further
Storage and Manufacture by CUSTOMER
1.
|
CUSTOMER
bears the sole responsibility for proper storage of the products
in its
own works or by a third party, once the product has left the premises
of
SUPPLIER.
|
2.
|
CUSTOMER
is responsible for further manufacturing steps that are conducted
by
itself or by third persons, after the products have left SUPPLIER’s
premises.
|
3.
|
CUSTOMER
is responsible to insure that the further manufacturing steps do
not have
adverse effects to the Contract
Products.
|
Page
8
from 24
§
14 Passing
on of Complaints and Product Observations by CUSTOMER
1.
|
CUSTOMER
is obligated to inform SUPPLIER without delay of all third party
complaints with respect to Contract Products manufactured by
SUPPLIER.
|
2.
|
The
obligation to observe the product and the development of scientific
knowledge, especially according to the rules of product liability,
is the
sole responsibility of CUSTOMER. Correspondingly, § 14.1 of this Agreement
applies to the results of the
observation.
|
3.
|
If
SUPPLIER receives any complaint or report of an adverse event with
respect
to Contract Products manufactured for CUSTOMER hereunder from a
third
party, such complaint or adverse event report shall be communicated
in
writing by SUPPLIER to CUSTOMER within
[**].
|
§
15 Protected
Rights
CUSTOMER
represents that no protected rights, patents or other intellectual property
rights of third parties will be infringed on by manufacturing the contract
product, and especially by passing on of the manufacturing and inspection
instructions from CUSTOMER to SUPPLIER, including the instructions on the
starting and packing materials.
Except
as
expressly stated herein, nothing in this Agreement shall constitute or grant
any
implied license or ownership in proprietary rights or permission to file
any
patent, copyright or any other intellectual property rights to either party
under the other Party’s intellectual property.
§
16 Inspections
Upon
reasonable notice to SUPPLIER, CUSTOMER is entitled to inspect SUPPLIER’s
installations for manufacture and control of medication, and to look into
the
lot documentation maintained by SUPPLIER according to Appendix 6 for "Contract
Products" manufactured on behalf of CUSTOMER. Such inspections may
include, but will not be limited to, cGMP inspections, quality audits, and
system audits, including observation of the actual process of manufacture
of the
contract product. Representatives of CUSTOMER will have access during
such inspections to all contract product related documents, records, reports,
data, procedures, facilities, and all other information required to be
maintained by applicable legal regulations or the requirements of governmental
agencies.
SUPPLIER
will permit the inspection by any relevant regulatory authority of the Territory
which is required as part of the regulatory approval of the Contract Products,
including the inspection of: (a) the manufacturing facilities; (b) quality
control procedures; and (c) records and reports pertinent to the manufacture
of
the Contract Products.
SUPPLIER
will inform CUSTOMER promptly, but in no event later than [**], of any inspection
or audit
by any governmental agency that is specifically related to the contract product.
Moreover, SUPPLIER will inform CUSTOMER of the result of any such audit or
inspection within [**] of
the conclusion of such audit or
Page
9
from 24
inspection.
SUPPLIER will promptly provide CUSTOMERwith copies of any government issued
inspection observation reports and related correspondence that specifically
affect the contract product. SUPPLIER and CUSTOMER will cooperate in
resolving any concerns with the applicable governmental agency.
§
17 Legal
Situation Upon Termination of the Agreement
SUPPLIER
agrees to return all materials not yet processed and supplied free of charge
by
CUSTOMER, as well as all instructions and documents received from CUSTOMER,
not
withholding any copies, to CUSTOMER upon termination of this
Agreement.
Documents
which may be required for presentation to the authorities are
excluded.
Contract
Products ordered by CUSTOMER and already manufactured by SUPPLIER will be
supplied to CUSTOMER against the payment agreed on.
Already
purchased starting materials will be paid by CUSTOMER
In
the
event of the termination of this Agreement pursuant to § 20.1 hereof, SUPPLIER
will fulfil all orders given prior to the date of termination, even when
Contract Products will be delivered after the contract terminates
§
18 Prohibition
of Transfer
This
Agreement and the rights granted herein shall be binding upon, and shall
inure
to the benefit of the legal successors or assigns to any party. Both parties
shall not be entitled to assign, subcontract or transfer any rights or any
obligations under this Agreement to a third party except upon prior written
consent of the other party.
§19
Trademarks
Each
party hereby acknowledges that no party has, nor shall it acquire, any interest
in any of the other party’s trademarks or trade names unless otherwise expressly
agreed to in writing. The parties agree not to use any trademark or
trade name of the other party, except as specifically authorized by the other
party.
§
20 Recall
CUSTOMER
shall be responsible for instituting a contract product recall. If SUPPLIER
with
reasonable cause were of the opinion that the contract product should be
recalled, and CUSTOMER does not agree, then CUSTOMER shall release SUPPLIER
from
all consequent financial and liability obligations.
CUSTOMER
shall notify SUPPLIER of any recall, which may be related to manufacture,
components, testing or any other work performed by SUPPLIER.
SUPPLIER
shall provide a rapid initial response and then a full report as soon as
possible. The two parties shall cooperate on the response to the
authorities.
Page
10
from 24
§
21 Final
Provisions
1.
|
This
Agreement becomes valid when it has been signed by both parties
to this
Agreement. It is concluded for two years and automatically extends
for one
year unless one party terminates this Agreement giving 3 months
notice to
the end of the first or to the end of any subsequent validity periods
by
registered letter.
|
2.
|
Each
party shall have the right to terminate this Agreement on written
notice
to the other party, if the other party breaches a material term
of this
Agreement and if breaching party fails to remedy the breach within
[**] of
receiving written notice of the
breach.
|
Each
party may terminate this Agreement immediately in its entirety if the other
party files a petition of bankruptcy, is adjudged bankrupt, takes advantage
of
any insolvency act, or executes a xxxx of sale, deed of trust, or assignment
for
the benefit of creditors.
3.
|
Amendments
and supplements to this Agreement and its appendices can be made
only in
mutual agreement and must be set out in
writing.
|
4.
|
Place
of settlement for all deliveries and payments is 74429
Xxxxxxxx-Laufen.
|
5.
|
The
exclusive jurisdiction for all disputes arising from this contract
shall
be with the courts of70173 Stuttgart,
Germany.
|
6.
|
If
individual provisions of this Agreement should be or should become
invalid, the agreement in its entirety shall remain valid. With
reference
to the invalid provisions the parties to this Agreement will endeavour
to
replace the invalid provision by a valid provision, resembling
the
original, invalid provisions as closely as possible, and which
fulfil the
economic purposes of the original, invalid
provisions.
|
|
7.
|
This
Agreement shall be subject to German Law, to the exclusion of the
conflict
of laws provisions thereof.
|
8.
|
All
necessary changes regarding this Agreement and the appendices,
shall be
documented in Appendix 0.
|
9.
|
Any
notice given under this Agreement must be in writing and will be
deemed
duly given or made if given to a party personally or sent by registered
post, mail or facsimile to the address or facsimile number shown
below:
|
If
to
CUSTOMER:
Cytogen
Corporation
000
Xxxxxxx Xxxx Xxxx, Xxxxx 0000
Xxxxxxxxx,
Xxx Xxxxxx 00000
Attn:
Xxxxxxx X. Xxxxxxxxx, Ph.D., Senior Vice President, Operations
FAX:
(000) 000-0000
Mail:
xxxxxxxxxx@xxxxxxx.xxx
Page
11
from 24
With
a
copy to:
Xxxxxxx
X. Xxxxxx, Esq.
Senior
Vice President and General Counsel
Cytogen
Corporation
000
Xxxxxxx Xxxx Xxxx
Xxxxxxxxx,
XX 00000
Fax
No.: (000) 000-0000
Mail:
xxxxxxx@xxxxxxx.xxx
If
to
SUPPLIER:
HOLOPACK
Xxxxxxxxxxxxxxxxxx
XxxX
Xxxxxxxxxxxxx
00000
Xxxxxxxx-Xxxxxx 1
Attn:
Managing Director
FAX:
0000
0000 0000
Mail:
xxxx@xxxxxxxx.xx
10.
|
The
rights and obligations contained in § § 4.2, 10, 11.1, 17, 19 20 and 21
shall survive termination of this Agreement, as will any rights
to payment
or other rights or obligations have accrued under this Agreement
prior to
termination. Termination will not affect a party's liability
by
reason of any act, default, or occurrence to termination. Section
9 shall
survive termination of this Agreement for an additional 5
years.
|
11.
|
A
party's failure to require another party to comply with any provision
of
this Agreement shall not be deemed a waiver of such provision or
any other
provision of this Agreement.
|
12.
|
Except
as otherwise expressly provided in this Agreement, each party shall
pay
its own expenses and costs incidental to the preparation of this
Agreement
and to the consummation of the transactions contemplated
hereby.
|
13.
|
The
parties shall be deemed to be independent contractors, and this
Agreement
shall not be construed to create between SUPPLIER and CUSTOMER
a
relationship such as, by way of example only, that of employer-employee,
principal agent, joint-venturer, co-partners or any similar relationship,
the existence of which is expressly denied by the parties
hereto.
|
14.
|
This
Agreement and the Quality Agreement constitute the full, complete,
final
and integrated agreement between the parties hereto relating to
the
subject matter hereof and supersedes all previous written or oral
negotiations, commitments, agreements, transactions or understandings
with
respect to the subject matter hereof. Any modification,
amendment or supplement to this Agreement must be in writing and
signed by
authorized representatives of both parties. In addition to the
foregoing, in the event of a conflict or inconsistency between
this
Agreement and the Quality Agreement, this Agreement shall prevail
and
control.
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12
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15.
|
Each
party agrees not to issue any press release or other public statement,
or
any communication or response to a third party, whether oral or
written,
disclosing the existence of this Agreement or any information or
activity
relating to this Agreement without the prior written consent of
the other
parties, provided however, that neither party will be prevented
from complying with any duty of disclosure it may have pursuant
to law or
governmental regulation, including any international, federal or
state
securities laws.
|
16.
|
The
titles and headings herein are for convenience only and shall not
be used
to interpret or construe the terms and conditions of this
Agreement.
|
17.
|
This
Agreement may be executed in counterparts, each of which shall
be deemed
an original, but all of which together shall constitute one and
the same
instrument. The parties expressly agree that signatures
received via facsimile shall be accepted as
originals.
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|
Appendices:
|
Appendix
1:
|
Contract
Products
|
Appendix
2:
|
Manufacturing
directions
|
Appendix
3:
|
Quality
control directions/Product
Specifications
|
Appendix
4:
|
Starting
Material/Packing
material Specifications
|
|
-
Supplied by SUPPLIER -
|
Appendix
5:
|
Starting
Material/Packing material
Specifications
|
|
-
Supplied by CUSTOMER -
|
Appendix
6:
|
Documentation
|
Appendix
7:
|
Packing
Directions
|
Appendix
8:
|
Responsible
Personnel
|
Appendix
9:
|
Prices,
Payment Terms
|
Appendix
0:
|
Revision
history
|
Princeton,
New Jersey USA
|
Xxxxxxxx-Laufen,......
|
Cytogen
Corporation
|
HOLOPACK
|
Verpackungstechnik
GmbH
By:
/s/ Xxxxxxx X. Xxxxxx
|
By:
/s/ Xxxx Xxxxx
|
|
Xxxxxxx
X. Xxxxxx, President
|
Xxxx
Xxxxx
|
|
and
Chief Executive Officer
|
Managing
Director
|
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APPENDIX
1
[**]
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APPENDIX
2
[**]
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APPENDIX
3
[**]
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APPENDIX
4
[**]
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APPENDIX
5
[**]
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APPENDIX
6
[**]
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APPENDIX
7
[**]
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APPENDIX
8
[**]
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APPENDIX
9
[**]
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APPENDIX
0
[**]
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