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DEVELOPMENT AND LICENCE AGREEMENT

Development Agreement

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

XENOVA GROUP PLC | OXXON THERAPEUTICS LIMITED

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Title: DEVELOPMENT AND LICENCE AGREEMENT
Date: 5/27/2005
Industry: Biotechnology and Drugs     Sector: Healthcare

DEVELOPMENT AND LICENCE AGREEMENT, Parties: xenova group plc , oxxon therapeutics limited
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* CONFIDENTIAL INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE

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

BY AN [_].

 

                                                                    Confidential

 

 

                                  XENOVA LIMITED

 

 

 

                                       AND

 

 

 

                           OXXON THERAPEUTICS LIMITED

 

 

 

 

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

 

                        DEVELOPMENT AND LICENCE AGREEMENT

 

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

 

 

 

 

 

 

 

                               Anderson & Company

                               76 Wallingford Road

                                  Shillingford

                                   Oxon OX10 7EU

                           wwww.andersonsolicitors.com

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                        DEVELOPMENT AND LICENCE AGREEMENT

 

 

THIS AGREEMENT dated 12th January 2005 is made between:

 

(1)     XENOVA LIMITED (company registration number 01970244) ("Xenova") a

       company incorporated in England and Wales whose registered office is at

       957 Buckingham Avenue, Slough, Berkshire SL1 4NL; and

 

(2)     OXXON THERAPEUTICS LIMITED (company registration number 03671700)

       ("Oxxon") a company incorporated in England and Wales whose principal

       place of business is at Florey House, 3 Robert Robinson Avenue, The

       Oxford Science Park, Oxford OX4 4GP.

 

RECITALS:

 

A.      Xenova is the beneficial owner of certain Xenova Patent Rights, and

       possesses certain Xenova Know-how and Xenova Materials relating to the

       DISC-HSV Vector.

 

B.       Oxxon has expertise in developing immunotherapeutic products based on a

       proprietary Heterologous PrimeBoost approach. Oxxon also has expertise in

       developing viral based antigen delivery vectors for the treatment of

       cancer and infectious disease.

 

C.      Oxxon wishes to pursue the further development and commercialisation of

       the DISC-HSV Vector in Selected Indications and Fields, in accordance

       with the provisions of this Agreement.

 

D.      Xenova is willing to grant to Oxxon, and Oxxon is willing to accept, a

       licence in the Selected Indications in the Field under the Xenova Patent

       Rights 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                   In relation to a Party, means any entity or person

                           that Controls, is Controlled by, or is under common

                           Control with that Party.

 

ARISING INTELLECTUAL        Any and all of the Arising Patents, Arising Know-how

PROPERTY                    and Arising Materials.

 

ARISING KNOW-HOW            Technical, commercial and all other information

                           generated by Oxxon during the continuation of this

                           Agreement that relates to any of the Xenova

                           Intellectual Property or any Licensed Product(s),

                            including any scientific or regulatory data, product

                           licence applications and approvals, clinical trial

                           licence applications and approvals, and development

                            and marketing plans and activities.

 

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ARISING MATERIALS           Any and all materials that may be generated or

                            developed by Oxxon in the course of this Agreement,

                           including any materials based on or derived from any

                           Xenova Materials.

 

ARISING PATENTS             Any and all patents and patent applications that may

                           be applied for or obtained in respect of any

                           invention(s) made by Oxxon during the continuation

                           of this Agreement and which relate to any Xenova

                           Intellectual Property, 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.

 

BLA                         A biologies license application (as that term is

                           used in Title 21 of the United States Code of Federal

                           Regulations) filed with the FDA seeking regulatory

                           approval to market and sell any Licensed Product in

                           the United States for a particular indication or the

                           non-U.S. equivalent thereof.

 

COMMENCEMENT DATE           The date of execution of this Agreement by the

                           Parties.

 

CONTROL                     Direct or indirect beneficial ownership of 50% (or,

                           outside a Party's home territory, such lesser

                           percentage as is the maximum permitted level of

                           foreign investment) 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.

 

 

DEVELOPMENT AND             The development and commercialisation plan for

COMMERCIALISATION PLAN      Licensed Product(s), the initial programme for which

                           is briefly summarised in Schedule 3, to be further

                           defined in accordance with Clause 3.1 and as may be

                           amended from time to time by Oxxon.

 

 

DEVELOPMENT AND             The report described in Clause 3.4 as amended from

COMMERCIALISATION REPORT    time to time.

 

DISC-GMCSF                  A recombinant virus that has been developed by

                           Xenova and is designated dH2T, and which is a

                           disabled infectious single cycle herpes simplex type

                           2 virus that expresses the cytokine human

                            granulocyte macrophage colony stimulating factor

                           from the gH locus from which the gH gene has been

                           deleted.

 

DISC-HSV VECTOR             A disabled infectious single cycle herpes simplex

                            virus from which the gH gene has been deleted and/or

                           from which another gene that is essential for virus

                           replication may be deleted, and into which a

                           different gene(s) is or will be substituted, as a

                           result of which substitution the virus expresses

                           heterologous gene(s). The foregoing definition shall

                           include DISC-GMCSF which has been genetically

                           modified.

 

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                           For the avoidance of doubt, a DISC-HSV vector that

                           is "empty" (including but not limited to the vector

                           known as dH2A), that is to say it does not express

                           any heterologous gene(s) as described in the

                            previous sentence of this definition, is excluded

                           from the definition of DISC-HSV Vector for the

                           purposes of this Agreement.

 

 

[_] YEAR PERIOD             The period commencing on the Commencement Date and

                           ending on the earlier of (a) the [_] anniversary

                           of the Commencement Date; and (b) any termination of

                           this Agreement.

 

 

FDA                         The United States Food and Drug Administration and

                           any successor agency or authority thereto.

 

FIELD                       Field A and Field B.

 

FIELD A                     The use of DISC-HSV Vector in Heterologous

                            PrimeBoost regimes (where the DISC-HSV Vector is

                           either the [_] or [_]) for prophylactic   and

                           therapeutic applications for the Indications.

 

                           For the avoidance of doubt, for the purposes of this

                           Agreement, Field A shall not include the use of

                           DISC-HSV Vector in the prophylactic setting for the

                           prevention of herpes virus infection/disease.

 

FIELD A INDICATIONS         Those Indications that Oxxon selects for use in

                           Field A in accordance with the provisions of

                           Clause 4.3.

 

FIELD B                     The use of DISC-HSV Vector or DISC-GMCSF as a

                           [_] for prophylactic and therapeutic

                           applications for the Indications.

 

                           For the avoidance of doubt, for the purposes of this

                           Agreement, Field B shall not include the use of

                           DISC-HSV Vector in the prophylactic setting for the

                           prevention of herpes virus infection/disease.

 

FIELD 8 INDICATIONS         Those Indications that Oxxon selects for use in

                           Field B in accordance with the provisions of

                           Clause 4.3.

 

FURTHER INDICATIONS         Those additional indications other than the

                           Indications and the Haematology Indications, as

                           defined in this Agreement that Oxxon selects in

                           accordance with Clause 4.3(d)(ii).

 

HAEMATOLOGY INDICATIONS     The application of Licensed Product to transduce

                            cells selected from the group consisting of

                           haematopoietic cells, malignant cells of the

                           haematopoietic lineage, and malignant or

                           non-malignant CD34+ cells.

 

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HETEROLOGOUS                A multi-stage heterologous regimen involving the

PRIMEBOOST                  sequential delivery of an antigen to both prime and

                           boost an immune response. The antigen used in the

                           prime and boost may or may not be identical. For the

                           avoidance of doubt, the prime and/or boost may be

                           undertaken one or more times.

 

IND                         An Investigational New Drug Application filed or to

                           be filed with the FDA with regard to a Licensed

                           Product prior to beginning clinical trials of any

                           Licensed Product or the non-U.S. equivalent thereof.

 

INDICATIONS                 [_]

 

INITIAL INDICATIONS         Those Field A Indications and/or Field B Indications

                            that Oxxon selects in accordance with Clauses 4.3(b)

                           and (c).

 

JOINT DEVELOPMENT           A committee to be established, and operating, in

FORUM                       accordance with the provisions of Clause 2.

 

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

 

LICENSED PRODUCT(S)         Any and all products that incorporate DISC-GMCSF or

                           DISC-HSV Vector and that are manufactured, sold or

                           otherwise supplied by Oxxon or Sub-licensees and

                           which (a) are within any Valid Claim of the Xenova

                           Patent Rights; and/or (b) incorporate, or their

                           development makes use of, any of the Xenova Know-how

                           or the Xenova Materials. References in this

                           Agreement to different Licensed Products (e.g., the

                           first and second Licensed Products) shall be

                            understood as referring to Licensed Products that

                           require, or will require, separate Marketing

                           Authorisations in the United States of America.

 

MARKETING AUTHORISATION     Regulatory approval to market and sell a Licensed

                           Product in any part of the Territory and shall

                           include, without limitation, approval granted with

                           respect to any BLA, NDA or the non-US equivalent

                           thereof.

 

NDA                         A new drug application (as that term is used in

                           Title 21 of the United States Code of Federal

                           Regulations) filed with the FDA seeking Regulatory

                           Approval to market and sell any Licensed Product(s)

                           in the United States for a particular indication or

                           the non-U.S. equivalent thereof.

 

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NET SALES VALUE             The invoiced price of Licensed Product(s) sold by

                           Oxxon or any of its Affiliates (or, in the context

                           of Clause 6.6(b) its Sublicensees, or in the context

                           of Clause 6.7 and 6.11 Oxxon or any of its Affiliates

                           and/or its Sublicensees) to independent third

                            parties in arm's length transactions exclusively for

                           money or, where the sale is not at arm's length, the

                           price that would have been so invoiced if it had

                            been at arm's length, after deduction of normal trade

                           discounts actually granted and any credits actually

                           given, and, provided the amounts are separately

                           charged on the relevant invoice, any costs of

                           packaging, insurance, carriage and freight, any

                           value added tax or other sales tax, and any import

                           duties or similar applicable government levies.

 

OPT-IN FEES                 The fees described in Clause 6.4.

 

PARTIES                     Xenova and Oxxon, and "Party" shall mean either of

                           them.

 

PATENTS                     Any and all of the Xenova Patent Rights and the

                           Arising Patents.

 

PHASE I STUDIES             As to a specific Licensed Product, one or more

                           controlled and lawful studies in humans, the

                           principal purpose of which is a preliminary

                           determination of safety of the Licensed Product for

                           its intended use in healthy individuals or patients

                           to support its continued testing in similar clinical

                            trials prescribed by the FDA or any relevant foreign

                           regulatory authority.

 

PHASE II STUDIES            As to a specific Licensed Product, one or more

                           controlled and lawful studies in humans of the

                           safety, dose ranging and efficacy of such Licensed

                           Product, which is prospectively designed to generate

                           sufficient data (if successful) to commence Phase III

                           Studies of such product.

 

PHASE III STUDIES           As to a specific Licensed Product, one or more

                           controlled and lawful studies in humans of the

                           efficacy and safety of such Licensed Product, which

                           is prospectively designed to demonstrate

                           statistically whether such Licensed Product is

                           effective and safe for use in a particular indication

                            in a manner sufficient to file a BLA or NDA to

                           obtain regulatory approval to market and sell that

                           Licensed Product in any part of the Territory for

                            the indication being investigated by the study.

 

PRE-CLINICAL STUDIES        As to a specific Licensed Product, in vitro or in

                           vivo (non-human) studies, including but not limited

                           to evaluation of the safety, immunogenicity,

                           pharmacology or toxicity profile of a therapeutic

                           agent.

 

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REASONABLE AND DILIGENT     Exerting such efforts and employing such resources as

EFFORTS                     would normally be exerted or employed by a

                           reasonable, [_] when utilizing sound and   reasonable

                            scientific, business and medical practice and

                           judgment in order to develop the product in a timely

                           manner and maximise the economic return to the

                           Parties from its commercialisation.

 

 

REVOCATION PROCEEDINGS      Any proceedings before a national or international

                           Patent Office where the validity of any of the

                           Xenova Patent Rights is at issue including opposition

                           proceedings in respect of European patents and

                           interference proceedings in respect of US patents,

                           but excluding any proceedings that form part of, or

                            are linked with, proceedings in which allegations of

                           patent infringement are made.

 

ROYALTY RECEIPTS            The amount of any royalties received by, or due to,

                           Oxxon or any of its Affiliates calculated on the

                           sale of Licensed Product(s) less any Value Added

                           Tax.

 

SELECTED INDICATIONS        The Field A Indications (if any) and the Field B

                           Indications (if any).

 

SUB-LICENSEE                Any third party (including an Affiliate of Oxxon) to

                           whom Oxxon has sub-licensed any of Oxxon's rights

                           under this Agreement.

 

TERRITORY                   The World.

 

UPFRONT RECEIPTS            Subject to Clause 6.6(a)(iii) and (iv), the amount of

                           any payment (excluding Value Added Tax), and the

                           value of any non-monetary receipt, obtained by, or

                            due to, Oxxon or its Affiliate, by way of "upfront"

                           or initial consideration (whether payable in one or

                           more instalments) in relation to the sub-licensing

                           (including the grant of any option over a

                           sub-licence) of any Xenova Intellectual Property,

                           and including any of the following:

 

                           (a)   up-front payments due under any sub-licence

                                 agreement;

 

                           (b)   payments in excess of a fair market rate for

                                the funding of research or development

                                activities related to any Licensed Product;

 

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

                                cross- licensing arrangements, the value of any

                                third party licence obtained under such

                                 arrangements;

 

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

                                 shares, options or other securities in respect

                                of any of the share capital of Oxxon 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

                                Oxxon 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.

 

VALID CLAIM                 A claim of a patent or patent application that has

                           not expired or been held invalid or unenforceable by

                           a court of competent jurisdiction in a final and

                           non-appealable judgment.

 

XENOVA INTELLECTUAL         Any and all of the Xenova Patent Rights, Xenova

PROPERTY                    Know-how and Xenova Materials.

 

XENOVA KNOW-HOW             Technical information in the possession of Xenova or

                           its Affiliates in the Field relating to (a) DISC-HSV

                           Vector and/or (b) the inventions claimed in the

                           Xenova Patent Rights, and being further described in

                           the attached Schedule 2.

 

XENOVA MATERIALS            Physical materials in the possession of Xenova or its

                           Affiliates in the Field relating to (a) DISC-HSV

                            Vector and/or (b) the inventions claimed in the

                           Xenova Patent Rights, being those described in the

                           attached Schedule 2 and such other materials in the

                           possession of Xenova or its Affiliates that:

 

                           (a)   were developed by Xenova or its Affiliates in

                                its research and development programme for

                                DISC-HSV prior to the Commencement Date; and

 

                           (b)   fall within the categories set out in Schedule

                                2; and

 

                           (c)   Oxxon may reasonably request for the development

                                of Licensed Product(s); and

 

                           (d)   of which Xenova or its Affiliates is the

                                beneficial owner; and

 

                           (e)   which Xenova or its Affiliates is not prevented

                                 from providing as a result of a pre-existing

                                agreement with a third party.

 

 

XENOVA PATENT RIGHTS        The patents and patent applications described in the

                           attached Schedule 1 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.

 

 

XENOVA REPRESENTATIVES      Mr Terry Stancliffe and Dr Elizabeth Rollinson and

                           the executive board directors of Xenova.

 

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2       JOINT DEVELOPMENT FORUM

 

2.1     Formation, Within 90 days after the Commencement Date, the Parties shall

       establish a Joint Development Forum, by each Party designating its

       initial members to serve on the Joint Development Forum and notifying the

       other Party of its dates of availability for the first meeting of the

       Joint Development Forum. At the Joint Development Forum Oxxon shall

        report to Xenova on its progress in developing Licensed Product(s) for

       purposes of commercialization in the Field in the Territory. The Joint

       Development Forum shall consist of up to three (3) representatives

       designated by each Party. Each Oxxon representative shall have relevant

       and appropriate development expertise in order to report on and discuss

       the development of the Licensed Product(s). If a representative of a

       Party is unable to attend a meeting of the Joint Development Forum, such

       Party may designate an alternate to attend such meeting. In addition,

       each Party may, at its discretion, invite a reasonable number of other

       employees, consultants or scientific advisors to attend the meetings of

       the Joint Development Forum, provided that such invitees are bound by

       appropriate confidentiality obligations. Each Party may change one or all

       of its representatives to each Joint Development Forum at any time upon

       notice to the other Party.

 

2.2     Meetings, The Joint Development Forum shall meet every six months and at

       such other times as the Parties may agree. The first meeting of the Joint

       Development Forum shall be held as soon as reasonably practicable, but in

       no event later than 90 days after the Commencement Date. Meetings shall

       be held at such place or places as are mutually agreed or by

       teleconference or videoconference; provided, however, that there shall be

       at least one face-to-face meeting per calendar year.

 

2.3     Responsibilities. During the continuation of this Agreement, the Joint

       Development Forum shall:

 

       (a)     receive reports from Oxxon on the progress of the development of

              Licensed Products;

 

       (b)     provide Xenova with an opportunity to comment on the Development

              and Commercialisation Plan;

 

       (c)     enable Xenova to provide information to Oxxon that it has in its

              possession or control which may facilitate Oxxon's development of

              Licensed Products; and

 

       (d)     facilitate the initial transfer of Xenova Know-How between the

              Parties for purposes of enabling Oxxon to develop Licensed

              Products;

 

        For the avoidance of doubt the Joint Development Forum shall not have any

       role or responsibility in relation to determining whether Oxxon has

       complied or will comply with its obligations to Xenova under Clauses 3 or

       7.1.

 

2.4     Disputes. If agreement cannot be reached within the Joint Development

       Forum, Oxxon shall have the right to make the final determination

       concerning the resolution of the disagreement.

 

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3       DEVELOPMENT

 

3.1     Development and Commercialisation Plan; IND filing. Without prejudice to

       the generality of Oxxon's obligations under Clause 7.1, Oxxon shall:

 

       (a)     Within [_] of Oxxon making its selection of its first Indication

              pursuant to Clause 4.3(b) Oxxon shall create a Development and

              Commercialisation Plan based on the initial, summary Development

              and Commercialisation Plan set out in Schedule 3, which will set

              out Oxxon's proposed development of Licensed Product(s) in

              relation to such first Indication. The Development and

              Commercialisation Plan shall describe in outline Oxxon's

              development activities for the applicable Licensed Product in the

              applicable Indication. Oxxon will update the Development and

              Commercialisation Plan on a regular (and at least six-monthly)

              basis, and such updates shall address the relevant stage of

              development and commercialization of the Licensed Product(s)

              including information under the headings set out in Part 2 of

              Schedule 3 as and when such information is available; and

 

       (b)     Oxxon shall use Reasonable and Diligent Efforts to file, within

              [_] of selecting each Indication in accordance with Clause 4.3, an

              IND for a Licensed Product for such Indication. In the event that

              Oxxon is in breach of its obligation to use Reasonable and

              Diligent Efforts to file in accordance with this Clause 3.1(b)

              then Xenova shall only be entitled to exercise any right of

              termination under Clause 10.2.2 if Oxxon is in breach of its

              obligation in respect of all Selected Indications.

 

3.2     Development activities. With respect to each Licensed Product, Oxxon

       shall be responsible for the development and commercialisation of such

       Licensed Product in the Field in the Territory in accordance with the

       Development and Commercialisation Plan. Such development and

       commercialisation shall be carried out in accordance with the provisions

       of this Agreement.

 

3.3     Development costs. Oxxon shall bear all costs associated with the

       development of Licensed Product(s), including costs incurred in

       connection with the Development and Commercialisation Plan save that

       Xenova shall bear its own costs associated with attending and

       participating in the Joint Development Forum as set out in Clauses 2.1 to

       2.4 . If Xenova agrees with Oxxon to conduct work as part of the

       Development and Commercialisation Plan, Xenova's costs of conducting such

       work shall be borne by Oxxon, with the time costs of Xenova

       representatives being charged to Oxxon on a full-time equivalent (FTE)

       basis. Xenova's FTE rate for its representatives shall be agreed between

       the Parties but in any event it shall be not less than [_] per annum (on

       a pro-rata basis) plus all product-related consumable costs and external

       costs associated with such work. For the avoidance of doubt, these rates

       shall not apply to any manufacturing work performed by Xenova, which

       would be the subject of separate manufacturing agreement(s) as may be

       agreed in writing by the Parties.

 

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3.4     Reporting. Without prejudice to the generality of Oxxon' s obligations

       under Clause 7.1, Oxxon shall provide a Development and Commercialisation

       Report to Xenova at least twice per year to Xenova (and in any event

       prior to each meeting of the Joint Development Forum), summarising its

       past, current and projected activities taken or to be taken by Oxxon to

       bring Licensed Product(s) to market and maximise the sale of Licensed

       Product(s) worldwide; and from time to time at Xenova's reasonable

       request and on reasonable notice Oxxon shall provide details of such

       activities. Xenova's receipt or approval of any such report shall not be

       taken to waive or qualify Oxxon's obligations under Clause 7.1.

 

4.      GRANT OF RIGHTS

 

4.1     Licences to Xenova Intellectual Property. Xenova hereby grants to Oxxon,

       subject to the provisions of this Agreement, the following licences in

       the Field:

 

        (a)     an exclusive licence under the Xenova Patent Rights, with the

              right to sub-license, subject to Clause 4.6, to develop,

              manufacture, have manufactured, use and sell product(s) in the

              Field in the Territory for the Selected Indications; and

 

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

              Materials, with the right to sub-license, subject to Clause 4.6,

              to develop, manufacture, have manufactured, use and sell

              product(s) in the Field in the Territory for the Selected

              Indications.

 

       For the avoidance of doubt, Oxxon shall only be entitled to exploit the

       rights granted to Oxxon under the licences set out in Clauses 4.1 (a) and

       4.1(b) in respect of the Field A Indications in Field A, and in respect

       of the Field B Indications in Field B.

 

4.2     [_]

 

4.3     Selection of Indications. The licences granted under Clause 4.1 are

       limited to the Indications that Oxxon selects in accordance with the

       provisions of this Clause 4.3, as follows:

 

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       (a)     Oxxon shall have the exclusive right to select one or more of the

              Indications, in Field A and/or in Field B, subject to the

              provisions of the following paragraphs of this Clause 4.3. In

              respect of each Indication, Oxxon shall exercise this right from

              time to time by giving written notice to Xenova, within the

              relevant time-limit referred to in this Clause, stating the

              Indication and whether it is selected for Field A or Field B.

 

       (b)     Within [_] of the Commencement Date, Oxxon will select [_]

              Indications in Field A.

 

 

       (c)     Within [_] of the Commencement Date, Oxxon will select [_]

              Indications in Field B.

 

       (d)     Provided that Oxxon has selected [_] Indications in Field A and

              [_] Indications in Field B in accordance with the time limits

              stated in paragraphs (b) and (c) above:

 

              (i)     during the [_], Oxxon may select [_] further Indications in

                      Field A and/or in Field B, subject to payment of the Opt-in

                     Fees in respect of each Indication that is selected in

                     either of Field A or Field B.

 

              (ii)    Provided that Oxxon has [_] develop such Further

                     Indications in accordance with this Agreement, during the

                     [_] Oxxon may notify Xenova of Further Indications in Field

                     A and/or in Field B that it wishes to select.

 

               (iii)   On receipt of a valid notice pursuant to Clause 4.3(d)(ii)

                     Oxxon shall, subject to Clause 4.3(d)(iv) be entitled to a

                     licence to such Further Indication in accordance with

                     Clause 4.1.

 

              (iv)    In the event that Xenova has granted prior rights to any

                     third party and as a result is not able to grant a licence

                     to Oxxon in accordance with Clause 4.3(d)(iii) or such

                      grant would result in Xenova being in breach of its

                     obligations under any agreement with a third party, Xenova

                     shall offer to Oxxon a licence to the Further Indication to

                     the extent available. Such licence shall, to the extent

                     possible, reflect the terms of the licence granted to Oxxon

                     under Clause 4.1 and the other provisions of this Agreement

                     (including its financial provisions) save that, if the

                     rights granted are less than those provided for under

                     Clause 4.1, the Parties will negotiate in good faith to

                     agree the appropriate royalty rate payable in respect of

                      such licence and for the avoidance of doubt no such licence

                     shall be granted until all of the terms of the licence

                     agreement have been agreed in writing.

 

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                                                                    Confidential

 

              (v)     Oxxon's right of selection under this paragraph (d) shall

                     continue during the [_], except that this right shall [_]

                      of the Commencement Date if Oxxon [_], on or before the due

                     date, the annual fee that is due on that [_] under Clause

                     6.4(a) ("Payment Default"). Except where Oxxon's rights

                     have expired due to [_], Oxxon may extend its right of

                     selection under Clause 4.3(d)(ii) beyond the [_] for

                     successive periods of [_] by [_] on or before the [_] of

                     the Commencement Date and on [_] of the Commencement Date

                     the annual fee due under Clause 6.4(b).

 

4.4     Arising Intellectual Property.

 

4.4.1   Oxxon shall own all Arising Intellectual Property.

 

4.4.2   Oxxon agrees to grant to Xenova an exclusive, worldwide licence under

       Arising Intellectual Property outside the Field on reasonable commercial

       terms, to research, develop, make, have made, import, use, sell and

       otherwise deal in any and all products and processes outside the Field.

       If the Parties are unable to agree such terms within 90 days of either

       Party requesting the negotiation of such terms ("Exclusivity Period")

       then Oxxon shall not be obliged to grant a licence to Xenova and shall be

       free to discuss and conclude with third parties licensing agreements

       relating to the Arising Intellectual Property.

 

4.5     Formal licences. If requested by Oxxon, and at Oxxon'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 territories. 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.

 

4.6     Sub-licensing. Oxxon shall be entitled to grant sub-licences (which for

       the purposes of this Clause 4.6 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 Oxxon), provided that:

 

       (a)     Oxxon enters into a written agreement with each Sub-licensee;

 

       (b)     the sub-licence shall impose appropriate obligations on the

              Sub-licensee which are equivalent to the obligations on Oxxon

              under Clauses 3.4,4.4, 5.5 to 5.8, 6.12, 7 and 10 of this

              Agreement; and

 

                                       13

 

 

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                                                                    Confidential

 

       (c)     [_]

 

       (d)     within [_] following the grant of any sub-licence Oxxon shall

              notify Xenova that a sub-licence has been entered into and provide

              a true copy of the sub-licence agreement to Xenova; and

 

       (e)     for as long as Oxxon remains a party to the sub-licence agreement,

              Oxxon shall be [_] of the sub-licence agreement by the

              sub-licensee, as if [_] had been that of Oxxon under this

              Agreement.

 

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

       licence(s) expressly granted by the provisions of this Clause 4, 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. It is understood and agreed that under

       regulatory GCP Xenova will be required to retain archive samples of

       Xenova Materials and archive originals or copies of Xenova Know-how. For

       the avoidance of doubt, no rights are granted under this Agreement in the

       Haematology Indications.

 

4.8     Quality. Oxxon shall be responsible for ensuring that all Licensed

       Product(s) marketed by it or its Sub-licensees are of satisfactory

       quality and comply with all applicable laws and regulations in each part

       of the Territory. Oxxon's liability in respect of such responsibilities

       shall be in accordance with the provisions of Clause 9.2.3.

 

5.      KNOW-HOW AND CONFIDENTIAL INFORMATION

 

5.1     Provision of Know-how. Upon Oxxon's reasonable request, Xenova shall free

       of charge supply Oxxon with all Xenova Know-how in existence at the

       Commencement Date that Xenova is at liberty to disclose and that has not

       previously been disclosed to Oxxon and which is reasonably necessary to

       enable Oxxon to undertake the further development of the Licensed

       Product(s). In addition, Xenova shall free of charge supply to Oxxon all

       information which Xenova or its Affiliates receives from any regulatory

       body after the Commencement Date in response to filings made before the

       Commencement Date to the extent that such information relates to the

       Xenova Intellectual Property and would assist Oxxon in the development of

       Licensed Products. The Xenova Know-how shall be subject to the

       confidentiality provisions of Clause 5.6. If Oxxon requires any technical

       support or training to enable it to develop Licensed Products then the

       parties will discuss such requirements and negotiate in good faith to

       agree the terms under which such support or training will be provided.

 

                                       14

 

 

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                                                                    Confidential

 

5.2     Transfer of Materials. Xenova shall supply to Oxxon the Xenova Materials

       in accordance with the provisions of Schedule 2 and in such manner as the

       Parties may agree with a view to ensuring the stability and safe delivery

        of the samples of the Xenova Materials.

 

5.3     Status of Know-how and Materials. Oxxon acknowledges that the Xenova

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

       Subject to Clause 9, 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 Patent

       Rights provided under this Agreement are provided "as is" and without any

        express or implied warranties, representations or undertakings.

 

5.4     Responsibility for development of Licensed Product(s). Oxxon shall be

       exclusively responsible for the technical and commercial development and

       manufacture of Licensed Product(s) and for incorporating any

       modifications or developments thereto that may be necessary or desirable

       and for all Licensed Product(s) sold or supplied, and accordingly Oxxon

       shall indemnify Xenova in the terms of Clause 9.2.3.

 

5.5     Use of Know-how. Oxxon undertakes that for a period of [_] from the

       date of first commercial sale of Licensed Product(s) hi the Territory or

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

       the obligations of confidence of Clause 5.6, whichever is the shorter, it

       will not use the Xenova Know-how for any purpose except [_].

 

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

 

       (a)     to maintain as secret and confidential all Know-how and other

              technical or commercial 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

              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.

 

5.7     Exceptions to obligations. The provisions of Clause 5.6 shall not apply

        to Know-how and other information which the Receiving Party can

       demonstrate by reasonable, written evidence;

 

       (a)     was, pr


 
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