Back to top

LICENCE AND DEVELOPMENT AGREEMENT

Development Agreement

LICENCE AND DEVELOPMENT AGREEMENT | Document Parties: XENOVA GROUP PLC | XENOVA LIMITED | XENOVA RESEARCH LIMITED | CANCER RESEARCH TECHNOLOGY LIMITED You are currently viewing:
This Development Agreement involves

XENOVA GROUP PLC | XENOVA LIMITED | XENOVA RESEARCH LIMITED | CANCER RESEARCH TECHNOLOGY LIMITED

. RealDealDocs™ contains millions of easily searchable legal documents and clauses from top law firms. Search for free - click here.
Title: LICENCE AND DEVELOPMENT AGREEMENT
Date: 5/27/2005
Industry: Biotechnology and Drugs     Sector: Healthcare

LICENCE AND DEVELOPMENT AGREEMENT, Parties: xenova group plc , xenova limited , xenova research limited , cancer research technology limited
50 of the Top 250 law firms use our Products every day

 

 

* CONFIDENTIAL INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE

SECURITIES AND EXCHANGE COMMISSION. REDACTED PORTIONS OF THIS EXHIBIT ARE MARKED

BY AN [_].

 

 

                                 XENOVA LIMITED

 

 

                                        AND

 

 

                             XENOVA RESEARCH LIMITED

 

 

                                       AND

 

 

                       CANCER RESEARCH TECHNOLOGY LIMITED

 

 

 

 

                   -------------------------------------------

 

                         LICENCE AND DEVELOPMENT AGREEMENT

 

                   -------------------------------------------

 

 

 

 

 

 

 

                               Anderson & Company

                              76 Wallingford Road

                                  Shillingford

                                  Oxon OX10 7EU

                           www.andersonsolicitors.com

                           --------------------------

 

<PAGE>

 

                        DEVELOPMENT AND LICENCE AGREEMENT

 

THIS AGREEMENT dated 10 January 2005 is made between:

 

(1)    XENOVA LIMITED ("Xenova") a company incorporated in England and Wales

      whose registered office is at 957 Buckingham Avenue, Slough, Berkshire SL1

      4NL; and

 

(2)    XENOVA RESEARCH LIMITED a company incorporated in England and Wales whose

      registered office is at 957 Buckingham Avenue, Slough, Berkshire SL1 4NL;

      and

 

(3)    CANCER RESEARCH TECHNOLOGY LIMITED ("CRT") a company incorporated in

      England and Wales whose registered office is at Sardinia House, Sardinia

      Street, London WC2A 3NL.

 

RECITALS:

 

A.     Xenova Research Limited (formerly known as Cantab Pharmaceuticals Research

      Limited) and Cancer Research Campaign Technology Limited (now Cancer

      Research Technology Limited) entered into a licence agreement dated 6

      March 1996 (the "Prior Licence Agreement") in respect of certain L2 Patent

      Rights. The Prior Licence Agreement was terminated by Xenova Research

      Limited in January 2004. Under Clause 9.1.3 of the Prior Licence

       Agreement, CRT is entitled to request a licence from Xenova Research

      Limited in respect of certain intellectual property rights that may be

      required by CRT for the commercial exploitation of the L2 Patent Rights.

      Xenova Research Limited and CRT intend that the licences granted to CRT

      under this Agreement shall be in satisfaction of such obligations as

      Xenova Research Limited may have under Clause 9.1.3 of the Prior Licence

      Agreement.

 

B.     Xenova Research Limited has assigned the beneficial interest in all of its

      right, title and interest in the Xenova Intellectual Property to Xenova,

      although certain Xenova Patents remain registered with Patent Offices in

      the name of Xenova Research Limited (or Cantab Pharmaceuticals Research

      Limited). Accordingly, Xenova is the beneficial owner of certain Xenova

      Patents, and possesses certain Xenova Know-how and Xenova Materials

      relating to TA-CIN, a recombinant fusion protein vaccine comprising

       L2/E6/E7 from HPV 16.

 

C.     Xenova is willing to grant to CRT, and CRT is willing to accept, a licence

      in the Field under the Xenova Patents and to use the Xenova Know-how and

      Xenova Materials, all in accordance with the provisions of this Agreement.

 

IT IS AGREED AS FOLLOWS:

 

1      DEFINITIONS

 

In this Agreement, the following words shall have the following meanings:

 

AFFILIATE                   means in relation to a Party, any entity or person

                           that Controls, is Controlled by, or is under common

                           Control with that Party.

 

                                       1

 

<PAGE>

 

 

ARISING INTELLECTUAL        means any and all of the Arising Patents, Arising

PROPERTY                    Know-how and Arising Materials.

 

ARISING KNOW-HOW            means technical, commercial and all other information

                           generated by CRT or its Affiliates or Sub-licensees

                           during the continuation of this Agreement which is

                           not publicly known that relates to any of the Xenova

                           Intellectual Property or any Licensed Product,

                           including any scientific or regulatory data, product

                            licence applications and approvals, clinical trial

                           licence applications and approvals, and development

                           and marketing plans and activities.

 

ARISING MATERIALS           means any and all materials that may be generated or

                           developed by CRT or its Affiliates or Sub-licensees

                           in the course of this Agreement, including any

                           materials based on or derived from any Xenova

                           Materials.

 

ARISING PATENTS             means any and all patents and patent applications

                           that may be applied for or obtained in respect of

                           any invention(s) made by CRT, its Affiliates or

                           Sub-licensees during the continuation of this

                           Agreement and which relate to any Xenova Intellectual

                           Property or any Licensed Product, together with any

                            continuations, continuations in part, extensions,

                           reissues, divisions, and any patents, supplementary

                           protection certificates and similar rights that are

                            based on or derive priority from the foregoing.

 

COMMENCEMENT DATE           means the date of execution of this Agreement by the

                           Parties.

 

COMMERCIALISATION           means an agreement to be entered into between CRT

AGREEMENT                   and a permitted Sub-licensee (subject to the

                           provisions of this Agreement, including Clause 2.3)

                           as contemplated by Clause 5.1.

 

CONFIDENTIAL INFORMATION    means (a) all Know-How (including Arising Know-How),

                           (b) information relating to the Xenova Materials

                           and (c) information relating to the customers,

                           suppliers, business partners, clients, finances,

                           business plans, technical developments and products

                           (in each case actual or prospective) of a Party

                           which, in each case, is not publicly known and which

                            is acquired by the other Party pursuant to this

                           Agreement.

 

CONTROL                     means direct or indirect beneficial ownership of 50%

                           or more of the share capital, stock or other

                            participating interest carrying the right to vote or

                           to distribution of profits of that entity or person,

                           as the case may be; and "Controls" and "Controlled"

                            shall be interpreted accordingly.

 

CTM                         means finished product lot number 0864FP of TA-CIN

                           manufactured by Xenova and intended for use in

                           clinical trials

 

DEVELOPMENT AND             means the Development and Commercialisation Plan for

                           Licensed

 

                                       2

<PAGE>

 

COMMERCIALISATION PLAN      Product summarised in the attached Schedule 4, as

                           amended from time to time by agreement in writing of

                           the Parties.

 

DEVELOPMENT AND             means the report described in Clause 5.2 as amended

COMMERCIALISATION           from time to time.

REPORT

 

DILIGENT AND REASONABLE     means exerting such efforts and employing such

CRT EFFORTS                 resources as would normally be exerted or employed

                           by a reasonable third party company of similar size

                           to CRT for a product of similar market potential at

                           a similar stage of its product life, when utilizing

                           sound and reasonable scientific, business and medical

                           practice and judgment in order to appoint a

                           Sub-licensee in a timely manner who will undertake

                           to develop the product in a timely manner and

                           maximize the economic return to the Parties from

                            its commercialisation.

 

 

DILIGENT AND REASONABLE     means exerting such efforts and employing such

SUB-LICENSEE EFFORTS        resources as would normally be exerted or employed

                           by a reasonable third party company for a product of

                           similar market potential at a similar stage of its

                           product life, when utilizing sound and reasonable

                           scientific, business and medical practice and

                            judgment in order to develop the product in a timely

                           manner and maximize the economic return to the

                           Parties from its commercialisation.

 

DIRECT COSTS                means:

 

                            (a)    the Xenova Internal Costs;

                           (b)    the CRT Filling Costs; and

                           (c)    costs incurred by CRT in prosecuting,

                                 maintaining, enforcing and defending and

                                  commercialising the L2 Patents and the Xenova

                                 Intellectual Property that consist of:

 

                                 (i)    official filing fees;

                                 (ii)   patent agent costs;

 

                                 (iii) travel and out-of-pocket expenses;

                                 (iv)   courier charges and third party printing

                                       costs;

                                 (v)     any non-recoverable taxes or charges

                                       including value added tax which may be

                                       imposed; and

                                 (vi)   any other similar, external costs and

                                        expenses specifically associated with

                                       commercialisation of the L2 patents

                                       or/and the Xenova Intellectual Property,

                                        excluding the costs of general partnering

                                       conferences such as BIO.

 

FIELD                       means the prevention and treatment of HPV-related

                           diseases (including but not limited to vulval, anal

                           and cervical intraepithelial neoplasias and cervical

                           cancer) in humans.

 

                                       3

 

<PAGE>

 

 

GROSS RECEIPTS              means the amount of any payment (excluding Value

                           Added Tax), and the value of any non-monetary

                           receipt, obtained by, CRT or its Affiliate, in

                           relation to the commercialisation or sub-licensing

                            (including the grant of any option over a

                           sub-licence) of any Xenova Intellectual Property,

                           including any of the following:

 

                           (a)    up-front, milestone (whether at the stage of

                                 development, marketing or otherwise), success,

                                 bonus, maintenance and periodic (including

                                 annual) payments, royalty and minimum royalty

                                 payments, due under any sub-licence agreement;

 

                           (b)    payments in respect of the funding of research

                                 or development activities related to any

                                  Licensed Product, to the extent that such

                                 payments exceed a fair market price for such

                                 research or development;

 

                           (c)    where any sub-licence is to be granted under

                                 cross-licensing arrangements, the value of any

                                 third party licence obtained under such

                                 arrangements;

 

                           (d)    any premium paid over the fair market value of

                                 shares, options or other securities in respect

                                 of any of the share capital of CRT or its

                                 Affiliate (such fair market value to be

                                 determined on the assumption that Xenova

                                 had not granted, nor agreed to grant, any

                                 rights to CRT in respect of any Xenova

                                  Intellectual Property);

 

                           (e)    any loan, guarantee or other financial benefit

                                 made or given other than on normal market

                                 terms; and

 

                            (f)    any shares, options or other securities

                                 obtained from a third party.

 

HPV                         means Human Papilloma Virus

 

KNOW-HOW                    means the Xenova Know-how and the Arising Know-how.

 

L2 PATENTS                  means the patents and patent applications described

                           in the attached Schedule 2 and, in the case of the

                           patent applications, all patents arising therefrom

                            and all progeny applications arising from PCT

                           applications and patents arising therefrom and all

                           patent applications (and patents granted thereon)

                           which are related to those listed by the fact that

                           they are based on the same specification and/or

                           claim priority from the same fore-runner application

                           and/or as filed contain substantially the same

                           claims, together with any continuations,

                           continuations in part, extensions, reissues,

                           divisions, and any patents, supplementary protection

                            certificates and similar rights that are based on or

                           derive priority from the foregoing.

 

LICENSED PRODUCT            means any product for use in the Field, that is

                           manufactured, sold or otherwise supplied by CRT or

                           its Affiliate or Sub-licensee and which (a) is

                           within any Valid Claim of the Xenova Patents and/or

                           (b) incorporates, or its development makes use of,

                           any of the Xenova Know-how or the Xenova Materials

                           (whether or not in combination with any third party

                           technology).

 

                                       4

 

<PAGE>

 

 

MANCHESTER PHASE II         A Phase II study meeting the description set out in

STUDY                       Schedule 5.

 

NET RECEIPTS                means Gross Receipts less Direct Costs.

 

PARTIES                     means Xenova and CRT, and "Party" shall mean either

                           of them.

 

PATENTS                     means any and all of the Xenova Patents and the

                           Arising Patents.

 

QUARTER                     means each 3 month period ending on 31 March, 30

                            June, 30 September and 31 December.

 

SUB-LICENCE                 has the meaning given in Clause 2.3.

 

SUB-LICENSEE                means any person with whom CRT has entered into a

                           Sub-licence, subject to the provisions of Clause 2.3.

 

TA-CIN                      means a recombinant protein vaccine that has been

                           developed by Xenova that is a fusion protein

                           comprising HPV 16 L2/E6/E7 proteins.

 

TERRITORY                    means the World.

 

TOBACCO PARTY               means any corporation, company, partnership or other

                           organisation or person   with a material interest in

                           or links to the tobacco industry (other than

                           interests held by investment firms as part of a

                           portfolio of investments).

 

VALID CLAIM                 means a claim of a patent or patent application that

                           has not expired, been withdrawn, abandoned or

                           surrendered or been refused, revoked or held invalid

                           or unenforceable by a court or other governmental

                           agency of competent jurisdiction in a final and

                           non-appealable judgment.

 

XENOVA INTELLECTUAL         means any and all of the Xenova Patents, Xenova

PROPERTY                    Know-how and Xenova Materials.

 

XENOVA INTERNAL COSTS       means internal costs incurred or to be incurred by

                           Xenova in relation to the filling and lot release of

                           CTM for the proposed Manchester Phase II Study up to

                           a total aggregate sum of [_].

 

XENOVA KNOW-HOW             means technical information which is not publicly

                           known (including regulatory   dossiers) in the

                           possession of Xenova in the Field relating to (a)

                           TA-CIN and/or (b) the inventions claimed in the

                           Xenova Patents, and being further described in the

                           attached Schedule 3.

 

XENOVA MATERIALS            means physical materials (including cell banks and

                            CTM) in the possession of Xenova in the Field

                           relating to (a) TA-CIN and/or (b)

 

                                       5

 

<PAGE>

 

                           the inventions claimed in the Xenova Patents, and

                            being further described in the attached Schedule 3.

 

XENOVA PATENTS              means the patents and patent applications described

                           in the attached Schedule 1 and, in the case of the

                            patent applications, all patents arising therefrom

                           and all progeny applications arising from PCT

                           applications and patents arising therefrom and all

                           patent applications (and patents granted thereon)

                           which are related to those listed by the fact that

                           they are based on the same specification and/or claim

                           priority from the same fore-runner application

                           and/or as filed contain substantially the same

                           claims, together with any continuations,

                           continuations in part, extensions, reissues,

                           divisions, and any patents, supplementary protection

                           certificates and similar rights that are based on or

                           derive priority from the foregoing.

 

2.     GRANT OF RIGHTS

 

2.1    Licences to Xenova Intellectual Property. Xenova hereby grants to CRT,

      subject to the provisions of this Agreement:

 

(a)    an exclusive licence in the Field under the Xenova Patents, with the right

      to sub- license, subject to clause 2.3 below, to develop, manufacture,

       have manufactured, use and sell Licensed Product in the Field in the

      Territory; and

 

(b)    an exclusive licence in the Field to use the Xenova Know-how and the

      Xenova Materials, with the right to sub-license, subject to clause 2.3

      below, to develop, manufacture, have manufactured, use and sell Licensed

      Product in the Field in the Territory.

 

2.2    Formal licences. If requested by CRT, and at CRT's administrative cost,

      the Parties shall execute such formal licences as may be necessary or

      appropriate for registration with Patent Offices and other relevant

      authorities in particular jurisdictions. In the event of any conflict in

      meaning between any such licence and the provisions of this Agreement, the

      provisions of this Agreement shall prevail. The Parties shall use

      reasonable endeavours to ensure that, to the extent permitted by relevant

      authorities, this Agreement shall not form part of any public record. To

      the extent that Xenova Research Limited retains any right, title or

      interest in the Xenova Patents it joins with Xenova in granting the rights

      referred to in Clause 2.1 and undertakes to execute the formal licences

      referred to in this Clause 2.2.

 

2.3    Sub-licensing. CRT shall be entitled to grant sub-licences (which for the

      purposes of this clause shall include any option or right to acquire a

      sub-licence) of its rights under this Agreement to any person (including

      without limitation any Affiliate of CRT) ("Sub- licences), provided that:

 

      (a)    CRT shall (i) obtain Xenova's prior written consent (such consent

            not to be unreasonably withheld or delayed) to the execution of a

            term sheet, letter of intent or

 

                                        6

 

<PAGE>

 

            similar document ("Term Sheet") with the Sub-licensee, (ii) keep

            Xenova regularly informed of the progress of negotiations with each

            sub-licensee who has agreed a Term Sheet with CRT, and (iii) if it

            is proposed that the sub-licence agreement shall survive termination

            of this Agreement, obtain Xenova's prior written consent to the

            terms of the sub-licence agreement and to CRT's execution of the

             sub-licence agreement;

 

      (b)    the Sub-licence shall include obligations on the Sub-licensee which

            are equivalent to the obligations on CRT under Clauses 3, 5.2, 6.6,

            9.3 and 10 of this Agreement, as well as obligations on the

            sub-licensee to use at least Diligent and Reasonable Sublicensee

            Efforts to develop and commercialise Licensed Products, and CRT

            shall ensure that the Sub-licence agreement provides that Xenova

            may, in its own right, enforce all such obligations against the

            Sub-licensee;

 

      (c)    the Sub-licence shall include obligations on the Sub-licensee that

            all Licensed Products marketed by it are of satisfactory quality and

             comply with all applicable laws and regulations in each part of the

            Territory relevant to such Sub-licence.

 

      (d)    the Sub-licence shall terminate automatically on the termination of

            this Agreement for any reason (unless Xenova has given consent under

            clause 2.3(a)(iii)); and

 

      (e)    within 30 days of the grant of any Sub-licence CRT shall provide to

            Xenova a true copy of it.

 

2.4    Reservation of rights. For the avoidance of doubt, Xenova reserves the

      right to use Xenova Intellectual Property in the Field for the purposes of

      its own internal research only. It is understood and agreed that Xenova

      will be required under regulatory GCP to retain archive samples of Xenova

      Materials.

 

2.5    No other licence. It is acknowledged and agreed that except for the

      licence(s) expressly granted by the provisions of this clause 2, Xenova

      reserves all its rights. Without prejudice to the generality of the

      foregoing Xenova reserves all rights under the Xenova Intellectual

      Property outside the Field.

 

3      KNOW-HOW AND CONFIDENTIAL INFORMATION

 

3.1    Provision of Know-how. Within 30 days of the Commencement Date, Xenova

      shall supply CRT or its Sub-licensee (if any) with the Xenova Know-how. In

      addition, Xenova shall supply, in confidence, information in respect of

      the Xenova Intellectual Property, as available and to the extent Xenova is

      free to disclose it, to Sub-licensees or potential Sub-licensees of CRT as

      CRT shall reasonably request and as is required by such Sub-licensees or

      potential sub-licensees to decide whether to enter into or terminate any

      Sub-licence. The Xenova Know-how shall be subject to the confidentiality

       provisions of Clause 3.4. The method of such supply shall be as specified

      in the Schedule 3, but shall not require Xenova to undertake more than 5

      man-days work in respect of the obligation under this Clause 3.1 to

      provide the Xenova Know-How to the University of Manchester and potential

      Sub-licensees and more than 5 man-days work in respect of the obligation

      under this Clause 3.1 to provide the Xenova Know-How to actual

      Sub-licensees (ie a total

 

                                        7

 

<PAGE>

 

 

      maximum of 10 man-days) free of charge, unless otherwise agreed in writing

      between the Parties

 

3.2    Status of Know-how and Materials. CRT acknowledges that the Xenova

      Know-how and Xenova Materials are at an early stage of development.

      Accordingly, specific results cannot be guaranteed and any results,

      materials, information or other items, including the Xenova Know-how and

      Xenova Materials and inventions claimed in the Xenova Patents provided

      under this Agreement are provided "as is" and without any express or

      implied warranties, representations or undertakings. As examples, but

      without limiting the foregoing, Xenova does not give any warranty that

      Xenova Materials are of merchantable or satisfactory quality, are fit for

      any particular purpose, comply with any sample or description, or are

      viable, uncontaminated, safe or non-toxic.

 

3.3    Use of Know-how. CRT undertakes that for a period of 10 years from the

      date of first commercial sale of Licensed Product in the Territory or for

      so long as any substantial part of the Xenova Know-how remains subject to

      the obligations of confidence of Clause 3.4, whichever is the shorter, it

      will not use the Xenova Know-how for any purpose except as expressly

      licensed hereby and in accordance with the provisions of this Agreement,

      including, but not limited to clause 8 hereof.

 

3.4    Confidentiality obligations. Each Party ("Receiving Party") undertakes:

 

      (a)    save as permitted by this Agreement to maintain as secret and

            confidential Confidential Information obtained directly or

            indirectly from the other Party ("Disclosing Party") in the course

            of or in anticipation of this Agreement and to respect the

            Disclosing Party's rights therein,

 

      (b)    to use the same exclusively for the purposes of this Agreement, and

 

      (c)    to disclose the same only to those of its employees, contractors,

            customers, potential customers, potential Sub-licensees and

            Sub-licensees pursuant to this Agreement (if any) to whom and to the

            extent that such disclosure is reasonably necessary for the purposes

            of this Agreement.

 

3.5    Exceptions to obligations. The provisions of Clause 3.4 shall not apply to

      Confidential Information which the Receiving Party can demonstrate by

      reasonable, written evidence:

 

      (a)    was, prior to its receipt by the Receiving Party from the Disclosing

            Party, in the possession of the Receiving Party and at its free

            disposal;

 

      (b)    is subsequently disclosed to the Receiving Party without any

            obligations of confidence by a third party who has not derived it

            directly or indirectly from the Disclosing Party;

 

      (c)    is or becomes generally available to the public through no act or

            default of the Receiving Party or its agents, employees, Affiliates

             or sub-licencees; or

 

      (d)    in the case of Know-how, it has independently developed

 

                                       8

 

<PAGE>

 

 

3.6    Disclosure to court, etc. If the Receiving Party is required to disclose

      Confidential Information to the courts of any competent jurisdiction, or

      to any government regulatory agency or financial authority, such

      disclosure shall not be a breach of this clause 3, provided that the

      Receiving Party shall (i) inform the Disclosing Party as soon as is

      reasonably practicable, and (ii) at the Disclosing Party's request seek to

      persuade the court, agency or authority to have the information treated in

      a confidential manner, where this is possible under the court, agency or

       authority's procedures.

 

3.7    Disclosure to employees. The Receiving Party shall procure that all of its

      employees, contractors, consultants, advisers, customers, potential

      customers, potential sub-licensees and sub-licensees pursuant to this

      Agreement (if any) who have access to any of the Disclosing Party's

      Confidential Information to which Clause 3.4 applies, shall be made aware

      of and subject to these obligations and shall have entered into written

      undertakings of confidentiality at least as restrictive as Clauses 3.4 and

      which apply to the Disclosing Party's information.

 

4      MATERIALS

 

4.1    Supply of materials. Xenova shall supply the Xenova Materials or any of

      them, including CTM, to CRT (or CRT's nominee) in such quantities as CRT

      may reasonably request, within 30 days of such request. All such CTM

      supplied by Xenova under or in connection with this Agreement shall remain

      the absolute property of Xenova. For the avoidance of doubt, where Xenova

      Materials ot


 
SITE SEARCH

AGREEMENTS / CONTRACTS

Document Title:

Entire Document: (optional)

Governing Law:(optional)


Try our advanced search >>
 

CLAUSES

Search Contract Clauses >>

Browse Contract Clause Library>>

Get Email Updates
Email:
This is only a partial view of this document. We have millions of legal documents and clauses drafted by top law firms. learn more search for free browse for free learn more