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TERMINATION AGREEMENT

Termination Agreement

TERMINATION AGREEMENT | Document Parties: Valera Pharmaceuticals In You are currently viewing:
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Title: TERMINATION AGREEMENT
Date: 3/14/2005

TERMINATION AGREEMENT, Parties: valera pharmaceuticals in
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                                                                    Exhibit 10.5

 

                             TERMINATION AGREEMENT,

                             LICENCE BACK AND OPTION

 

DATED: 21st DECEMBER 2001

 

BETWEEN:

 

(1)   HYDRO MED SCIENCES, INC. ("HMS"), a subsidiary of GP Strategies Corporation

     ("GP"), a Delaware corporation with principal offices at 9 West Street,

     57th Street. Suite 4170, New York, NY 10019, USA; and

 

(2)   Shire US INC., a New Jersey Corporation with principal offices at 7900

     Tanners Gate Drive, Florence, Kentucky 41042, USA ("Shire").

 

RECITALS:

 

A.    Hydro Med Sciences, a division of GP (the "HMS Division"), and Shire

     entered into a Licence Agreement dated 24 March 1998 whereby Shire agreed

     to undertake the development of a pharmaceutical product containing

     Histrelin as an active pharmaceutical ingredient for the treatment of human

     prostatic carcinoma and was granted an exclusive licence to market such

     product in certain territories (the "Licence Agreement").

 

B.    The HMS Division and Shire entered into a manufacturing supply agreement

     dated 24 March 1998 in which the HMS Division agreed to supply Shire with

     research and commercial quantities of such product (as amended, the

     "Manufacturing Agreement").

 

C.    Shire and its Affiliates have undertaken certain development activities

     pursuant to the Licence Agreement and are in possession of valuable

     development data and know-how in relation to such product.

 

D.     The HMS Division has assigned the Licence Agreement and the Manufacturing

     Agreement to HMS.

 

E.    HMS has agreed to use its reasonable endeavors to either (i) seek a third

     party licensee to continue such development and to commercialise such

      product or (ii) develop and commercialise such product itself, and Shire

     and HMS have agreed to terminate the Licence Agreement and the

     Manufacturing Agreement and Shire has agreed to licence such development

     data to HMS for this purpose on the terms set out in this Agreement.

<PAGE>

OPERATIVE PROVISIONS

 

1.    INTERPRETATION

 

     1.1   Terms used in this Agreement shall (unless the context otherwise

          requires or unless specifically defined herein) have the same meanings

          as set out in the Licence Agreement.

 

     1.2   In this Agreement the following words shall have the following

          meanings unless the context otherwise requires:

 

     "Commercial Sale"          means a sale to a third party (other than an

                                Affiliate or a Sub-Licensee) for commercial use

                               of any Licensed Product in any country within the

                               Territory to include for the avoidance of doubt a

                                sale by a co-marketing partner or through a

                               contract sales force on reasonably standard

                               terms;

 

     "Development Data"         means all data, know-how and other information

                                relating to the Licensed Product generated in

                               connection with the Development Program in the

                               possession or control of Shire as at the date of

                               this Agreement:

 

     "Development Program"      means the development program for the Licensed

                               Product previously agreed by the Parties;

 

     "IND"                      means the Investigational New Drug authorisation

                                (No 40,772) given for the Licensed Product by the

                               Food and Drug Administration of the United States

                               of America;

 

     "Net Sales"                means "Net Sales" as defined in the License

                               Agreement with the additional deduction of the PC

                               Royalty and PROVIDED THAT sales by co-marketing

                               partners or through a contract sales force on

                                reasonably standard terms shall additionally

                               constitute Net Sales for the purposes of this

                               definition;

 

     "PC Royalty"               means any royalty payment properly paid by HMS to

                               the Population Council in respect of a sale of a

                               Licensed Product pursuant to the Termination of

                               Agreement

<PAGE>

                               dated September 12, 1990, dated September 26 and

                               October 1,1997, as amended, entered into by GP

                               and the Population Council;

 

     "Option"                   means the option granted by HMS to Shire to

                               market and distribute the Licensed Product in

                               each country of the Territory outside of the

                               United States of America as more particularly set

                                out in Clause 6 of this Agreement;

 

     "Sub-Licensee"             any person, firm or company (excluding

                               Affiliates, Shire pursuant to the exercise of the

                               Option and third parties who co-market the

                               Licensed Product in the Territory on reasonably

                               standard terms) licensed or appointed by HMS to

                               supply the Licensed Product in any country within

                               the Territory;

 

     "Sub-Licence Agreement"    means an agreement with a Sub-Licensee relating

                               to the development, use or sale of Licensed

                               Products;

 

     "Royalty Income"           all royalty or other Income received by HMS or an

                               Affiliate from any Sub-Licensee relating to the

                               sale or use of any part of the Development Data,

                                the Hydro Med Intellectual Property Rights and/or

                               the Licensed Product less the deduction of any PC

                               Royalty paid in respect of any sales of Licensed

                               Product by any such Sub-Licensee;

 

     "Transfer Date"            shall mean 23 April 2001.

 

     1.3   Except where the context otherwise requires, words denoting the

          singular include the plural and vice versa.

 

     1.4   Unless otherwise stated, a reference to a Clause is a reference to a

          Clause of this Agreement.

 

     1.5   Clause headings are for ease of reference only and do not affect the

          interpretation of this Agreement.

 

     1.6   This Agreement includes the Recitals.

 

2.    LICENCE GRANT

<PAGE>

\      2.1 Subject to the terms of the Option, Shire hereby grants to HMS with

          deemed effect from the Transfer Date an exclusive licence in the

          Territory (with the right to grant sub-licences) in the Field of Use

          to the Development Data for the development, manufacture, use, supply

          and sale of the Licensed Product.

 

     2.2   HMS shall use its reasonable endeavours to secure a Sub-Licensee or

          Sub-Licensees for the purposes of developing and commercialising the

          Licensed Product: provided that, in the United States of America. HMS

          may market the Licensed Product itself including by co-marketing or

          contract force arrangements. Any Sub-Licence Agreement shall be with a

           reputable pharmaceutical company on an arms-length basis and on

          commercial terms as favourable to HMS as is reasonably achievable in

          the circumstances. HMS shall notify Shire in advance of any

          Sub-Licence Agreement being entered into and shall provide Shire with

          a summary of relevant terms of such Sub-Licence Agreement, including

          royalties, up front and milestone payments.

 

     2.3   The term of the licence granted in Clause 2.1 shall continue for so

          long as royalties are payable pursuant to Clause 4; thereafter HMS

          shall have a fully paid up licence to the Development Data in the

          Territory in the Field of Use.

 

     2.4   In the event that HMS concludes a Sub-Licence Agreement outside of the

          United States of America, then the


 
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