Contract Manufacturing Agreement dated as of January 8, 2007 between the Company and Holopack Verpackungstechnik GmbH

dated

January 08th, 2007

b e t w e e n

HOLOPACK

a n d

CYTOGEN CORPORATION

 

650 College Road East

 

Princeton, New Jersey 08540 USA

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.

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.

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.

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.

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.

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.

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,

 

-

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.

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.

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.

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 Sulzbach-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 [**].

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.

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 CE-mark and shall be responsible for the manner of use of the CE-mark.

4.

CUSTOMER shall have the appropriate qualified personnel in accordance with §§ 30 and 31 MPG.

 

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.

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.

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.

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 [**].

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. [**].

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.

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.

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.

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 [**].

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.

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 Sulzbach-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:

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.

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.

 

Princeton, New Jersey USA

Sulzbach-Laufen,......

Cytogen Corporation

HOLOPACK

By: /s/ Michael D. Becker

By: /s/ Hans Weiss

 

Michael D. Becker, President

Hans Weiss

 

and Chief Executive Officer

Managing Director