EXCLUSIVE COMMERCIAL LICENCE OF TECHNOLOGY

1

Interpretation

1

2

Grant of Licence

2

3

Emergent Licence and Publication

5

4

Materials

7

5

Overall Development Plan

8

6

Isis Licence Agreement and Aeras Agreement

11

7

Infant Phase III Study

13

8

Manufacturing

14

9

Regulatory Matters

15

10

Exploitation

18

11

Data

18

12

Know-how, Improvements and Inventions

19

13

Patent Filing and Maintenance

22

14

Enforcement and Defence

24

15

Confidentiality

27

16

Payments

29

17

Emergent Parent Payment Obligation

31

18

Royalty Reports and Audit

31

19

Duration and Termination

32

20

Warranties

38

21

Liability and Indemnities

41

22

General

43

Schedule 1

Definitions and Interpretation

Schedule 2

Key Terms

Schedule 3

Overall Development Plan

Schedule 4

Data

Schedule 5

Groups of Territories

Schedule 6

Net Sales Adjustment

Schedule 7

University Collaborators

Schedule 8

University Agreements

Schedule 9

Infant Phase IIb Study Protocol

Schedule 10

Material Transfer Agreements

THIS AGREEMENT is made on

2008 (the “ Effective Date ”)

(1)

BADHUL LIMITED to be renamed OXFORD-EMERGENT TUBERCULOSIS CONSORTIUM LIMITED (Company No. 6631227) whose registered office is at 9400 Garsington Road, Oxford Business Park, Oxford OX4 2HN (the “ Company ”) ;

(2)

EMERGENT PRODUCT DEVELOPMENT UK LIMITED (Company No. 032070465) whose registered office is at 545 Eskdale Road, Winnersh, Wokingham, Berkshire RG41 5TU, England, United Kingdom (“ Emergent ”);

(3)

EMERGENT BIOSOLUTIONS INC. , a Delaware corporation with a place of business at 2273 Research Boulevard, Suite 400, Rockville, MD 20850, United States of America (“ Emergent Parent ”); and

(4)

ISIS INNOVATION LIMITED (Company No. 2199542) whose registered office is at University Offices, Wellington Square, Oxford OX1 2JD, England (“ Isis ”).

A.

Emergent and the University have established the Company as a joint venture company pursuant to a subscription and shareholders’ agreement of even date herewith (the “ SSA ”) for the purpose of developing and commercialising one or more vaccines incorporating MVA85A (or any improvements thereto) against Mycobacterium tuberculosis disease in humans, whether or not in combination with one or more other vaccines, against other diseases in humans.

B.

Isis is a wholly owned subsidiary of the University and the University has assigned its rights in certain technology and data to Isis.

C.

Isis has granted the Company a licence to certain technology and data pursuant to the Isis Licence Agreement and has given its consent to the Company to grant a sub-licence under such technology and data to Emergent.

D.

The Company wishes to license the Licensed Technology and the Company Data and Emergent wishes to acquire a licence to the Licensed Technology and the Company Data, on the terms of this agreement.

E.

Emergent Parent is the holding company of Emergent and joins this agreement solely for the purpose of agreeing to the payment obligation set forth in clause 17.

F.

Isis joins this agreement solely for the purposes of agreeing to the obligations in, and receiving the benefit from, clauses 2.3, 13 and 19.6.

1

Interpretation

1.1

Words and expressions used in this agreement have the meanings set out in schedule 1.

1.2

The provisions relating to interpretation set out in schedule 1 shall apply to this agreement.

1.3

Unless the context otherwise requires, any reference in this agreement to the Licensed Product is to each and every Licensed Product independently of each other.

1.4

If there is any inconsistency between the main body of this agreement and any schedule, the main body of this agreement shall prevail.

2

Grant of Licence

2.1

The Company grants to Emergent a licence under the Licensed Technology to:

2.1.1

undertake research with a view to Developing Licensed Products and Combination Products for use in the Field;

2.1.2

Develop and have Developed Licensed Products and Combination Products for use in the Field;

2.1.3

apply for, obtain and maintain Regulatory Approvals (other than Marketing Authorisations) for Licensed Products and Combination Products for use in the Field;

2.1.4

Manufacture, have Manufactured and otherwise make and have made, use and have used Licensed Products and Combination Products for use in the Field;

2.1.5

apply for, obtain and maintain Marketing Authorisations for Licensed Products and Combination Products in the Field in the Territory; and

2.1.6

Market Licensed Products and Combination Products in the Field in the Territory.

2.2

In addition to the rights granted pursuant to clause 2.1, the Company grants to Emergent a royalty-free, non-exclusive perpetual, irrevocable, worldwide licence (with the right to grant sub-licences without consent of, or accounting to, the Company) to use the Emergent ODP Technology and Company Manufacturing Technology in any field for any purpose and to access, reference and otherwise use and reproduce any Company New Data generated by any Emergent Company jointly with others, for any purpose.

2.3

The Company grants to Emergent a licence to access, reference and otherwise use and reproduce the Company Data and the Company Regulatory Documents for the purposes set out in clause 2.1. Subject to clauses 2.9 and 2.11, the licence in this clause 2.3 is co-exclusive with the Company for the purposes set out in clauses 2.1.1, 2.1.2 and 2.1.3, and exclusive for the purposes set out in clauses 2.1.4, 2.1.5 and 2.1.6, in each case other than in respect of the data detailed in schedule 4, part B, which is licensed on a non-exclusive basis. Isis will use its Efforts to obtain Control of the data, protocols, standard operating procedures and written documentation relating to trial TB012 (the “ TB012 Data ”) and trial GM920 (the “ GM920 Data ”) such that such data, protocols, standard operating procedures and written documentation may be licensed to the Company and, through the Company, to Emergent as Company Existing Data. The Company shall notify Emergent when it obtains such Control and such notice shall include details of whether TB012 Data and the GM920 Data should be included in part A or part B of schedule 4 and such schedule shall be deemed to be updated accordingly.

2.4

The Parties anticipate collaborating with each other and with Aeras to establish Correlates. If either Party establishes a Correlate whether solely or jointly with the other Party or Third Parties, then whether or not patentable:

2.4.1

that Party will provide the other Party with details of, and a perpetual, non-exclusive right to use and to permit others to use, any rights it has in, any Correlate; and

2.4.2

where the Correlate was established by the collaboration of the Parties with each other or with Aeras the Parties will, and will use their Efforts to procure that Aeras (and their or its sub contractors) will, comply with the provisions of clause 3.7 on publication.

2.5

As soon as is reasonably possible after the Effective Date and in any event within thirty (30) days of the Effective Date (or, with respect to the Documents, sixty (60) days of the Effective Date), the Company will:

2.5.1

at the Company’s cost, supply Emergent with the Documents and the Existing Data;

2.5.2

transfer or cause to be transferred to Emergent or its designee the reports from IDT to the University regarding process development forming part of the Company Manufacturing Technology; and

2.5.3

use Efforts, at Emergent’s cost, to commence the process to transfer the OMP Designation to Emergent.

2.6

Emergent may grant sub-licences under clauses 2.1 and 2.3 in accordance with this agreement through multiple tiers with the Company’s prior written consent, such consent not to be unreasonably withheld, conditioned or delayed; provided that, subject to clause 5.14, Emergent may, without the prior consent of the Company, grant sub-licences under clauses 2.1 and 2.3 to (i) sub-contractors appointed to undertake activities under the Overall Development Plan if and to the extent that such sub-licence is required to enable the sub-contractor to provide such services and does not include any right to Market any Licensed Product or Combination Product on its own account; and (ii) other Emergent Companies. Emergent may grant sub-licences under clause 2.2 through multiple tiers without the Company’s prior written consent. Emergent shall be entitled to perform any of its obligations under this agreement through Emergent Companies, sub-licensees and sub-contractors.

2.7

Subject only to termination by the Company in accordance with clauses 19.2 (Emergent’s insolvency) or 19.4 (Emergent’s breach) or by Emergent in accordance with clauses 19.3.1 (termination without cause), 19.3.3 (unsuccessful clinical trial) or 19.3.4 (safety concerns), the Licence is perpetual and irrevocable. The licence granted under clause 2.2 shall survive expiration or termination of this agreement for any reason with respect to Company Manufacturing Technology, Emergent ODP Technology and Company New Data conceived, discovered, developed or otherwise made prior to the Termination Date.

2.8

To the extent not previously disclosed to Emergent, within fifteen (15) Business Days of it being disclosed to the Company, the Company shall disclose and supply to Emergent all Company New Data, Licensed Technology and Company Regulatory Documents arising or generated after the Effective Date.

2.9

During the Term, the Company undertakes that it shall not except as expressly permitted by this agreement, grant or agree to grant any rights in the Licensed Technology, the Company Data or the Company Regulatory Documents in the Field; or assign, mortgage, charge or otherwise encumber or transfer any of the same; or disclose any Confidential Information contained therein; provided that the Company retains the right to:

2.9.1

use and sub-license Third Parties (with Emergent’s prior written consent, such consent not to be unreasonably withheld, conditioned or delayed), to use the Licensed Technology, the Company Data and the Company Regulatory Documents to develop the Manufacturing Process;

2.9.2

sub-license Isis (and through Isis, the University) to use the Licensed Technology, the Company Data and the Company Regulatory Documents for Non-Commercial Use in accordance with the Isis Licence Agreement;

2.9.3

enter into the Aeras Agreement; and

2.9.4

grant, if Emergent is unable or unwilling to supply Licensed Product or Licensor Combination Product to the University for use in Phase I Clinical Trials to be conducted by the University and notified to Emergent in accordance with clause 6.7, a non-exclusive, royalty-free licence under the Company Manufacturing Technology to a Third Party approved by Emergent (such approval not to be unreasonably withheld, conditional or delayed) to the extent necessary to enable that Third Party to Manufacture the required supplies of such Licensed Product or Licensor Combination Product for such Phase I Clinical Trial; provided that the Company shall procure that such Third Party shall keep the Company Manufacturing Technology confidential and shall not use it for any other purpose.

2.10

The Parties acknowledge that additional licences from Third Parties may be necessary to Exploit Licensed Products and Combination Products and, except as otherwise agreed, the Company shall be responsible for obtaining such licences. For the avoidance of doubt, if Emergent obtains any licence from a Third Party that is necessary to Exploit Licensed Products and Combination Products (if, and in the form, Developed or being Developed under the Overall Development Plan), in the Field, Emergent shall grant the Company a sub-licence for such purpose, subject to reimbursement of any royalties or other fees that Emergent is required to pay to such Third Party pursuant to such sub-licence.

2.11

If the Company requests Emergent to Manufacture Licensor Combination Product and such Manufacture requires access to or use of Manufacturing Technology or other Intellectual Property Rights Controlled by the University, Isis or the Company, the Company shall procure that Emergent is granted such access and licence for the sole purpose of Manufacturing such Licensor Combination Product for supply to the University or Company.

2.12

In the event that the Company determines that Emergent is not using Efforts to Market the Licensed Product within a specific country or countries in the Developed World (other than the public markets in China and India) in accordance with the Marketing Plan, the Company shall provide Emergent with written notice of such failure and a suggested corrective plan to enable Emergent to correct the asserted lack of diligence. Upon receipt of such notice and suggested corrective plan, Emergent

3

Emergent Licence and Publication

3.1

Emergent grants to the Company a royalty-free licence to use the Emergent Manufacturing Technology, to:

3.1.1

develop the Manufacturing Process;

3.1.2

apply for, obtain and maintain Regulatory Approvals (other than Marketing Authorisations) for Licensed Products and Company Combination Products for use in the Field; and

3.1.3

apply for, obtain and maintain Marketing Authorisations for Licensed Products and Company Combination Products for use in the Field outside the Territory.

3.2

Emergent grants to the Company a royalty-free licence to access, reference and otherwise use and reproduce the Emergent Data and the Emergent Regulatory Documents, to:

3.2.1

undertake research with a view to Developing Licensed Products and Company Combination Products for use in the Field;

3.2.2

Develop and have Developed Licensed Products and Company Combination Products for use in the Field;

3.2.3

apply for, obtain and maintain Regulatory Approvals (other than Marketing Authorisations) for Licensed Products and Company Combination Products for use in the Field;

3.2.4

apply for, obtain and maintain Marketing Authorisations for Licensed Products and Company Combination Products for use in the Field outside the Territory; and

3.2.5

Market Licensed Products and Company Combination Products in the Field outside the Territory.

3.3

Except as set out in clause 3.5, the Company may not grant sub-licences under clause 3.1 or 3.2 without Emergent’s prior written consent, such consent not to be unreasonably withheld, conditioned or delayed. The Parties acknowledge that Emergent has given its consent to the appointment by the Company of Aeras as a sub-licensee on the terms of the Aeras Agreement and to the performance of activities under the Overall Development Plan by the University.

3.4

As soon as reasonably practicable after it becomes available to Emergent, Emergent shall disclose and supply to the Company, all Emergent Data and Emergent Regulatory Documents arising or generated after the Effective Date.

3.5

The Company may grant:

3.5.1

to Isis and the University a non-exclusive, royalty-free licence for the University, University Personnel and University Collaborators to use and have used and, subject to prior review by Emergent, publish Emergent Data, in each case for Non-Commercial Use for so long and to the extent that the Company grants to Isis and the University an equivalent licence to use the Company Data; and

3.5.2

if the Company is unable or unwilling to supply Licensed Product or Licensor Combination Product to the University for use in Phase I Clinical Trials to be conducted by the University and notified to Emergent in accordance with clause 6.7, a non-exclusive, royalty-free licence under the Emergent Manufacturing Technology to a Third Party approved by Emergent (such approval not to be unreasonably withheld, conditional or delayed) to the extent necessary to enable that Third Party to Manufacture the required supplies of such Licensed Product or Licensor Combination Product for such Phase I Clinical Trial; provided that the Company shall procure that such Third Party shall keep the Emergent Manufacturing Technology confidential and shall not use it for any other purpose.

3.6

The Company will provide Emergent with a list of University Collaborators who have been granted access to or provided with MVA85A within sixty (60) days of the Effective Date. On Emergent’s written request within sixty (60) days of the end of each Licence Year, or at such other times as Emergent may reasonably request in writing, the Company shall update such schedule to include any other University Personnel or University Collaborators who have been granted access to or provided with MVA85A after the Effective Date.

3.7

Each Party (the “ Publishing Party ”) shall give to the other Party for review and approval all proposed academic, scientific and medical publications and public presentations, including audio visual presentations and posters, relating to activities conducted under the Overall Development Plan or otherwise generated using any Emergent Data, or Company Data, intended for publication no less than ten (10) Business Days before submission for publication or, if an abstract or materials for an oral presentation, five (5) Business Days before submission of the abstract or materials. The other Party may require any of its Confidential Information to be redacted from any such materials and may request that publication (through any media) be delayed for a period not exceeding three (3) months from the date of notification if such delay is necessary in order to protect Intellectual Property Rights in Emergent Data or Company Data. If the Publishing Party has not received any request for delay within ten (10) Business Days or, if an abstract or materials for an oral presentation, five (5) Business Days of the date of notification, the Publishing Party will be free to assume that the other Party has no objection to the proposed publication. Each Party shall comply with standard academic practice regarding authorship of scientific publications and recognition of the contribution of the other Party (and its sub-licensees and sub-contractors) in any publications and presentations.

3.8

The Company acknowledges that the Exploitation of Licensed Products and Company Combination Products and Licensor Combination Products by the Company or its permitted sub-licensees pursuant to clause 3 may require a licence under additional Intellectual Property Rights, including Intellectual Property Rights Controlled by Third Parties, and acknowledges that:

3.8.1

Emergent does not grant and shall not grant to the Company any rights with respect to any Licensed Product, Company Combination Product or Licensor Combination Product except as set out in clauses 3.1 and 3.2 and then only to the extent that the relevant Intellectual Property Rights are Controlled by Emergent;

3.8.2

any licence that may be granted to the Company pursuant to this agreement shall be subject to the rights (if any) that any Third Party may have in the relevant Licensed Product, Company Combination Product or Licensor Combination Product; and

3.8.3

Emergent does not make any warranties of any kind with respect to Emergent Data, Emergent ODP Technology or Emergent Manufacturing Technology or the Exploitation of Licensed Products or Combination Products including warranties with respect to quality, suitability or non-infringement.

4

Materials

4.1

The Master Seed Stock is and will remain the property of Isis.

4.2

As between the Parties, the Company Seed Stock will belong to the Company.

4.3

Emergent may use and have used the Master Seed Stock and the Company Seed Stock within the scope of the Licence and will not use or permit them to be used for any other purpose.

4.4

During the Term and for so long as Emergent has the right to manufacture Licensed Products or Combination Products, Emergent will have access to the Master Seed Stock and the Company Seed Stock as reasonably required in connection with the Exploitation of Licensed Products and Combination Products. In addition, Emergent will be entitled to exercise such Control over the Master Seed Stock (or a reasonable portion of it) and the Company Seed Stock as may be reasonably required by Emergent in connection with obtaining or maintaining any Regulatory Approval and the Company shall not unreasonably refuse to take, at Emergent’s cost, any action reasonably required by Emergent to protect the continuing availability and integrity of the Master Seed Stock and the Company Seed Stock as reasonably required for the Exploitation of Licensed Products and Combination Products. The Company will have access to the Master Seed Stock and the Company Seed Stock on reasonable notice and as reasonably required in connection with the exercise of the Company’s rights pursuant to clause 3; provided that the Company shall not exercise such rights of access in any manner that might adversely affect obtaining or maintaining any Regulatory Approval.

4.5

At the Effective Date the progenitor seed stock is held by the University and the remainder of the Master Seed Stock is held by IDT. If during the Term or while Emergent has the right to manufacture Licensed Products or Combination Products, IDT ceases to manufacture the Licensed Product or an additional manufacturer is

4.6

As between the Parties, Emergent Seed Stock will belong to Emergent.

4.7

Subject to clause 3.8, the Company and the University may use and have used the Master Seed Stock, the Company Seed Stock and the Emergent Seed Stock to the extent necessary to make, or have made, Licensed Product or Company Combination Products for use in their research in accordance with clause 3; provided that at all times there remains sufficient stock of Master Seed Stock, Company Seed Stock and Emergent Seed Stock to complete all activities planned under the Overall Development Plan.

5

Overall Development Plan

5.1

The Parties acknowledge that the Development of Licensed Products and Combination Products will be governed by the Overall Development Plan. The Overall Development Plan will identify all activities to be conducted by or on behalf of the Parties relating to the Development of any Licensed Product or Combination Product and will include the anticipated timelines for such activities; provided that if the Company does not wish to include the Development of an Emergent Combination Product in the Overall Development Plan, Emergent shall be entitled to Develop such Emergent Combination Product outside the Overall Development Plan. The Parties acknowledge that they will each be responsible for conducting certain activities under the Overall Development Plan and will cooperate in the performance of their respective activities under the Overall Development Plan.

5.2

Unless Emergent terminates this agreement pursuant to clause 19.3.6, or otherwise terminates this agreement prior to the commencement of the Infant Phase III Study, Emergent shall be responsible for obtaining funds for and undertaking the Infant Phase III Study in accordance with clause 7.1. The Parties will cooperate in preparing a draft protocol for the Infant Phase III Study at least six (6) months prior to the proposed commencement of the Infant Phase III Study and the Company shall provide such draft protocol to Aeras for review and comment in accordance with the Aeras Agreement. Emergent shall be responsible for finalising the draft protocol, provided that all comments provided by Aeras to the Company within the time permitted by the Aeras Agreement will be reasonably considered by Emergent. Emergent shall, not less than six (6) weeks prior to submission of such draft protocol to the relevant Regulatory Authorities and Ethics Committees, submit to the Company the final draft protocol together with the plan and budget for the Infant Phase III Study and the Overall Development Plan shall be updated in accordance with the Company’s procedures for adopting changes to the Overall Development Plan. If a relevant Regulatory Authority or Ethics Committee requires an amendment to the protocol, or Emergent otherwise chooses to amend the protocol, plan or budget for the Infant

5.3

For so long as any ongoing activities are being conducted by either Party under the Overall Development Plan:

5.3.1

Emergent shall have the right to appoint at least one (1) director to the Board;

5.3.2

the Company shall establish a steering committee to oversee the conduct of the Overall Development Plan and Budget and, acting by consensus, make recommendations to the Board;

5.3.3

Emergent shall have the right to appoint at least two (2) members to the Steering Committee; and

5.3.4

Emergent shall have the right to appoint at least one (1) representative on any steering committee established by Aeras, Isis, Emergent and Wellcome Trust in accordance with the Aeras Agreement;

5.4

The Company shall procure that the Steering Committee shall from time to time, and at least once in each Licence Year, review the Overall Development Plan and the Budget and recommend to the Board any changes, updates or amendments to the Overall Development Plan and/or the Budget it considers necessary. The Company shall procure that whenever the Steering Committee recommends to the Board any changes, updates or amendments to the Overall Development Plan and/or the Budget, the Steering Committee will provide a copy of such changes, amendments or updates to Emergent and the Company will specify the date on which it intends to adopt such updated Overall Development Plan and/or the Budget as the Overall Development Plan and/or the Budget (as the case may be).

5.5

Except with respect to the incorporation of Emergent’s protocol, plan and budget for the Infant Phase III Study and any amendments thereto submitted by Emergent to the Company in accordance with clause 5.2, any proposed change, update or amendment to the Overall Development Plan and the Budget, as the case may be, shall constitute a “ Material Change ” if such change, update or amendment would, if implemented:

5.5.1

result in Emergent being obliged to commit to the Company material additional finances or resources;

5.5.2

be reasonably likely to result in a delay (as against the then current timelines shown in the Overall Development Plan) of six (6) months or more in obtaining any Marketing Authorisation for a Licensed Product or any Combination Product (other than an Emergent Combination Product being Developed outside the Overall Development Plan) in the Territory and such delay:

5.5.2.1

is not commercially reasonable taking into account the resources then available to the Company; or

5.5.2.2

does not arise as a consequence or result of a delay to the completion of another activity under the Overall Development Plan where such original delay was beyond the reasonable control of the Company; or

5.5.3

result in a net reduction in the financial and other resources being committed to the Company and such reduction in resources would have a material adverse effect on the prospects of the Company obtaining Marketing Authorisation for a Licensed Product or Combination Product for any Indication.

5.6

No Material Change to the Overall Development Plan and/or the Budget of the type described in clause 5.5.1 may be adopted by the Company without the prior approval of Emergent to such change.

5.7

No Material Change to the Overall Development Plan and/or the Budget of the types described in clause 5.5.2 or clause 5.5.3 may be adopted by the Company without the prior approval of Emergent to such change (such approval not to be unreasonably withheld, delayed or conditioned).

5.8

Emergent will notify the Company in writing within twenty (20) Business Days of receipt of the draft revised Overall Development Plan and/or Budget, if it considers that any proposed change, update or amendment constitutes a Material Change. Such notice shall also indicate whether Emergent is granting or withholding its approval. If it is withholding its approval, such notice shall also include its reasons for withholding its approval. If no notification of approval or objection is sent to the Company within such twenty (20) Business Day period and at least one (1) reminder has been sent to Emergent during such twenty (20) Business Day period, Emergent shall have been deemed to have given its approval to the Material Change.

5.9

If Emergent approves the Material Change or it is deemed approved pursuant to clause 5.8, the Company shall be entitled to adopt the proposed Overall Development Plan and/or Budget incorporating such Material Change.

5.10

If Emergent does not approve a Material Change, the Company shall not implement such proposed Material Change.

5.11

If the Parties cannot, after using their respective reasonable endeavours, agree whether a proposed change, update or amendment to the Overall Development Plan and/or the Budget constitutes a Material Change, then the Company may and on Emergent’s requests shall, on not less than two (2) Business Days’ notice, procure that a meeting of the Steering Committee is convened to attempt to resolve the matter.

5.12

If following such meeting, the matter has not been resolved to the satisfaction of the Parties, either Party shall, within twenty (20) Business Days of such Steering Committee meeting, be entitled to refer the matter for determination by an Expert.

5.13

If the Expert Opinion determines that a proposed change, update or amendment to the Overall Development Plan and/or Budget constitutes a Material Change, then Emergent’s approval of such change shall be required in accordance with clauses 5.6 and 5.7. If the Expert Opinion determines that a proposed change, update or amendment to the Overall Development Plan and/or Budget does not constitute a Material Change, then the Company may adopt any such proposed change, update or amendment as the Overall Development Plan and/or the Budget for the purposes of

5.14

Each Party may sub-contract performance of its obligations under this agreement provided that:

5.14.1

the sub-contract protects the Licensed Technology, the Emergent Manufacturing Technology, the Data and the Regulatory Documents to no less extent than this agreement does;

5.14.2

the sub-contract imposes obligations of confidentiality equivalent to those contained in clause 15 and compliance with all relevant Regulatory Approvals and Applicable Law;

5.14.3

the sub-contracting Party uses its Efforts to obtain all rights arising under such sub-contract and which are necessary for the Exploitation of Licensed Product and Combination Products (if and in the form Developed or being Developed under the Overall Development Plan) in the Field; and

5.14.4

the sub-contracting Party uses its Efforts to procure that the sub-contract is assignable without consent to the other Party on termination of this agreement.

6

Isis Licence Agreement and Aeras Agreement

6.1

The Parties acknowledge that this agreement is a sub-licence to the Isis Licence Agreement and that the Aeras Agreement is also a sub-licence to the Isis Licence Agreement. The Company will not terminate either the Isis Licence Agreement or the Aeras Agreement (other than for the breach or insolvency of respectively Isis or Aeras) without Emergent’s prior written consent.

6.2

The Company will use its Efforts to enforce its rights and perform its obligations under the Isis Licence Agreement and the Aeras Agreement. Without prejudice to the generality of the foregoing, the Company will enforce its rights under the Isis Licence Agreement to procure that:

6.2.1

if requested by Emergent, the University shall remove Emergent’s Confidential Information from proposed publications and delay publication to protect any Intellectual Property Rights in Emergent Data;

6.2.2

the University shall handle, use and store any Samples, to which it has been granted access, in accordance with Applicable Law and the relevant Study Subject’s consent;

6.2.3

for any clinical trial involving a Licensed product or Combination Product conducted by the University, the University shall obtain the required consent from each Study Subject;

6.2.4

Isis and the University shall take such actions as Emergent may require in connection with securing Patent Extensions;

6.2.5

Isis and the University shall, if requested by Emergent, join as a party in legal actions against any misappropriation or infringement of any rights included in the Licensed Technology in the Field in the Territory; and

6.2.6

if requested by Emergent, the Isis License Agreement shall be terminated if Isis commits a material breach of that agreement and fails to remedy such breach within the applicable cure periods.

6.3

The Company will not amend, vary or terminate the Isis Licence Agreement or the Aeras Agreement without Emergent’s prior written consent (such consent not to be unreasonably withheld, conditioned or delayed). The Company will not enter into, or amend, vary or terminate, any further agreements with Aeras or any agreements with Third Parties relating to the supply or distribution of Licensed Products or Combination Products, without Emergent’s prior written consent (such consent not to be unreasonably withheld, conditioned or delayed). The Company shall not grant consent for Aeras to grant sub-licences in accordance with the Aeras Agreement, or to sub-contract the performance of Aeras’s Development activities under the Overall Development Plan, in each case without Emergent’s consent (such consent not to be unreasonably withheld, conditioned or delayed).

6.4

Emergent and the Company will explore avenues to supply Licensed Product to the public markets in China and India in consultation with Aeras. The Company will put forward Emergent’s proposal regarding such supply and if such proposal demonstrates to the reasonable satisfaction of Aeras that Emergent, acting with the Company, has a strategy for and the capability (including through partnering with Third Parties) to supply Licensed Products or Combination Products to the public markets in China and/or India in accordance with the principles set out in clause 8.2.1, then the public markets in China and/or India as appropriate will be deleted from the definition of the Developing World for this agreement and the Aeras Agreement with effect from the date on which such capability was demonstrated. Following such change to the definition of Developing World, Emergent shall, on reasonable notice and during reasonable business hours, permit the Company (and through it, Aeras) to audit Emergent’s supply of Licensed Products and Combination Products to the public markets in China and/or India. If the Company receives notice from Aeras that Emergent is materially failing to supply Licensed Products and Combination Products to the public markets in China and/or India in accordance with the principles set out in clause 8.2.1, the Company shall promptly forward such notice to Emergent. If, six (6) months after the date of such notice received by the Company from Aeras, Emergent is still materially failing to supply Licensed Products and Combination Products to the public markets in China and/or India in accordance with the principles set out in clause 8.2.1, the relevant public markets will be added back to the definition of the Developing World with effect from the end of such six (6) month period.

6.5

Other than in accordance with clauses 6.6 and 6.7, the Company will not permit Aeras to conduct any clinical trials on a Licensed Product or a Combination Product (other than the Infant Phase IIb Study), which are reasonably necessary or useful for Aeras to obtain a Regulatory Approval in the Developing World, without Emergent’s prior written approval of the protocol and study plans for such clinical trial (such consent not to be unreasonably withheld, conditioned or delayed), and the Company will not permit Aeras to conduct any other clinical trials on a Licensed Product or a Combination Product (other than the Infant Phase IIb Study) without Emergent’s prior written consent.

6.6

The Company will not permit the University to conduct any clinical work (other than a Phase I Clinical Trial notified to Emergent in accordance with clause 6.7) on a Licensed Product or a Combination Product outside the Overall Development Plan without

6.7

If the Company receives a request from the University to conduct a Phase I Clinical Trial, outside the Overall Development Plan, of a Licensed Product or a Licensor Combination Product, the Company shall, promptly upon receiving the draft protocol for such Phase I Clinical Trial from the University, provide a copy of such draft protocol to Emergent and shall notify Emergent of the deadline for the Company to provide comments to the University. The Company shall consider any and all comments received from Emergent before such deadline and, if requested by Emergent, shall provide such comments to the University.

7

Infant Phase III Study

7.1

Without prejudice to the generality of clause 5.1, and subject to clause 19.3.6, the availability of suitable trial sites, sufficient quantities of Licensed Product appropriate for the applicable clinical trial use being available and the relevant Regulatory Approvals having been obtained, Emergent will, if the Trial Success Criteria of the Bridging Study, the De-escalation Study and the Infant Phase IIb Study are achieved:

7.1.1

meet all the costs and expenses of a Phase III Clinical Trial for the Infant Indication (the “ Infant Phase III Study ”);

7.1.2

unless otherwise agreed by the Parties, act as sponsor of the Infant Phase III Study; and

7.1.3

use its Efforts to enrol the first subject in the Infant Phase III Study within twelve (12) months of the later of:

7.1.3.1

the date on which Regulatory Approval for the Infant Phase III Study is granted; and

7.1.3.2

the Successful Completion Date of the Bridging Study, the De-escalation Study, and the Infant Phase IIb Study.

7.2

If (i) the Trial Success Criteria for the Infant Phase IIb Study are not achieved; (ii) Emergent does not exercise its right to terminate this agreement pursuant to clause 19.3.6; and (iii) an Emergent Company subsequently commences the Infant Phase III Study pursuant to clause 7.1, the Trial Success Criteria for the Infant Phase IIb Study shall be deemed to have been achieved on the date the first Study Subject is dosed in the Infant Phase III Study and the Milestone Fee that would have been due upon the Successful Completion Date of the Infant Phase IIb Study shall become due on the date of such dosing and shall be payable in accordance with clause 16.3.

7.3

Emergent will, and will use its Efforts to ensure that its sub-contractors will, comply in all material respects with all relevant Regulatory Approvals and Applicable Law whilst conducting the Infant Phase III Study.

7.4

If, after completion of the Infant Phase III Study and production of the final clinical trial report, any Samples collected by or on behalf of Emergent during the Infant Phase III Study remain and are not required to be retained by the protocol, Emergent shall permit the Company or, at its direction, the University to access and use for Non-Commercial Use such excess Samples, subject to Applicable Law and the relevant

8

Manufacturing

8.1

The Parties will, through the Steering Committee, cooperate to develop the Manufacturing Process. It is anticipated that the Company will appoint one or more mutually acceptable Third Party manufacturers with appropriate expertise to undertake process development activities. Without prejudice to clause 5.14, if a Party appoints a Third Party to undertake any activities in connection with the Development of the Manufacturing Process, that Party will procure that the Company is licensed or otherwise granted access to any Intellectual Property Rights underlying such process development which do not vest in that Party. The Parties acknowledge that certain activities relating to the development of such manufacturing process will be funded by the Wellcome Grant.

8.2

Emergent will, working with the Company in accordance with clause 8.1, use its Efforts to develop a manufacturing process for a Licensed Product which:

8.2.1

is capable of producing [**] doses of Licensed Product in each year of manufacture within a specified number of years from the date on which the Infant Marketing Approval is granted (such number to be determined when the Aeras supply agreement is entered into) with the objective of being able to make, at the end of that number of years, at least [**] doses per year of the Licensed Product available to Humanitarian Organisations at an affordable level for use in the Developing World and on such development to supply Aeras or other Humanitarian Organisations such quantities of Licensed Product; provided that if and to the extent that Emergent or its sub-licensee is supplying the public markets in China and/or India at affordable prices, the number of doses to be made available to Humanitarian Organisations shall be reduced by the number of doses made available by Emergent or such sub-licensee at such prices to such markets.

8.2.2

with respect to Manufacture in or for EEA countries, fulfils the requirements of EMEA for the grant of Marketing Authorisation for the Licensed Product in the EEA.

8.3

Each of the Parties will, and will use its Efforts to ensure that its sub-contractors will, comply in all material respects with all relevant Applicable Law whilst conducting the manufacturing process development set out in clause 8.2.

8.4

Each of the Parties will, and will use its Efforts to ensure that its sub-contractors will, use its Efforts to ensure that all Regulatory Approvals required to undertake the work set out in clause 8.2 and any Manufacture of Licensed Product are obtained.

8.5

Each of the Parties will, and will use its Efforts to ensure that its sub-contractors will, provide to the other Party all chemistry, manufacturing and controls data (or a drug master file containing the same) relating to the Manufacture of Licensed Products or Combination Products and shall grant to the other Party a right of reference to such data and drug master files for the purpose of obtaining and maintaining Regulatory Approvals relating to the Exploitation of such Licensed Products or Combination Products.

8.6

Subject to clauses 2.9.1 and 8.1, the Company acknowledges that Emergent has the sole right to Manufacture and have Manufactured Licensed Products and Combination Products and that it is anticipated that Emergent may enter into agreements with one or more Third Parties to fulfil its obligations pursuant to clause 8.2. The Company will provide Emergent with all information relating to the anticipated demand for Licensed Product in the Developing World within ten (10) Business Days of receiving the same from Aeras or any other Developing World Distributor.

9

Regulatory Matters

9.1

Provided that the OMP Designation has been transferred to Emergent in accordance with clause 2.5.3 Emergent will use its Efforts to maintain the OMP Designation.

9.2

Each Party shall communicate to the other Party in writing any data relating to a Licensed Product or Combination Product of which it becomes aware which discloses a serious adverse event, promptly (and in any event within forty-eight (48) hours) and where that serious adverse event is a SUSAR, immediately. The Parties will (and where appropriate will use their Efforts to procure that their respective sub-licensees and sub-contractors will) enter into such further data safety exchange agreements as reasonably necessary to enable the Parties to comply with their reporting obligations under Applicable Law from time to time.

9.3

Neither Party will use in any capacity, in connection with the conduct of any activities involving any Licensed Product or Combination Product, the services of any party who has been debarred pursuant to Section 306 of the Federal Food, Drug, and Cosmetic Act, as amended, or who is the subject of a conviction described in such section.

9.4

Each Party will inform the other Party in writing immediately if it becomes aware that it, or any party who conducts any activities involving any Licensed Product or Combination Product, is debarred or is the subject of a conviction described in Section 306 of the Federal Food, Drug, and Cosmetic Act, as amended, or that any action, suit, claim, investigation or legal or administrative proceeding is pending or is threatened, relating to the debarment or conviction of it, or any party who conducts any activities pursuant to or authorised by this agreement.

9.5

Unless otherwise agreed by the Parties, Emergent shall be responsible for seeking, obtaining and maintaining all Regulatory Approvals necessary or reasonably useful for the conduct of all clinical trials conducted under the Overall Development Plan (other than the Infant Phase IIb Study and any clinical trial ongoing at the Effective Date) and shall be responsible for all communications with Regulatory Authorities or Ethics Committees concerning any such trial; provided that the Parties acknowledge that:

9.5.1

Aeras, the University and the Company shall be responsible for seeking, obtaining and maintaining all Regulatory Approvals necessary or reasonably useful for the conduct of the Infant Phase IIb Study and shall

9.5.2

the University shall be responsible for seeking, obtaining and maintaining all Regulatory Approvals necessary or reasonably useful for the conduct of any clinical trial ongoing at the Effective Date and any Phase I Clinical Trial notified to Emergent in accordance with clause 6.7 and shall be responsible for all communications with Regulatory Authorities or Ethics Committees concerning any such trials; and

9.5.3

subject to clause 6.5 and 9.10, Aeras shall be responsible for seeking, obtaining and maintaining all Regulatory Approvals necessary or reasonably useful for the conduct of any other clinical trials reasonably necessary or useful to secure Regulatory Approvals in the Developing World and shall be responsible for all communications with Regulatory Authorities or Ethics Committees concerning any such trials.

9.6

Subject to clauses 9.5 and 9.10, and unless otherwise agreed by the Parties, Emergent and its permitted sub-licensees shall be responsible for seeking, obtaining and maintaining all Regulatory Approvals relating to the Exploitation of Licensed Products and Combination Products in the Territory and the Company and its permitted sub-licensees (including Aeras) shall be responsible for seeking, obtaining and maintaining all Regulatory Approvals relating to the Exploitation of Licensed Products and Company Combination Products outside the Territory, provided that Emergent and its permitted sub-licensees shall have the exclusive right to seek, obtain and maintain all Marketing Authorisations in the Territory.

9.7

Prior to making any submission to a Regulatory Authority, including any application or document in support of a Marketing Authorisation or other Regulatory Approval (other than with respect to a Combination Product Developed or being Developed outside the Overall Development Plan in accordance with clause 5.1), the Parties shall, and the Company shall procure that the University and Aeras shall, through the Steering Committee and, where appropriate any committee established under the Aeras Agreement, consult and cooperate in preparing such filings. Each Party shall have the right to review and comment on all such submissions to Regulatory Authorities in accordance with specific timelines or other arrangements agreed on by the Steering Committee; provided that, unless otherwise agreed in writing by the Parties, each Party shall allow the other Party at least thirty (30) days to review and comment on any such submissions to Regulatory Authorities and shall reasonably consider any and all timely comments received from the other Party with respect to such submissions.

9.8

Subject to clauses 9.5 and 9.10, and unless otherwise agreed by the Parties, Emergent shall be responsible for responding to all communications relating to a Licensed Product or Combination Product received from a Regulatory Authority or Ethics Committee in the Territory and the Company shall be responsible for responding to all communications relating to a Licensed Product or Company Combination Product received from a Regulatory Authority or Ethics Committee outside the Territory.

9.9

Each Party will, and the Company will use its Efforts to procure that the University and Aeras, promptly notify the other Party of (i) any communication received by it from any Regulatory Authority or Ethics Committee relating to a Licensed Product or Combination Product and (ii) any proceedings initiated by any Regulatory Authority relating to a Licensed Product or Combination Product. To the extent practicable, the Party responsible for responding to such communication pursuant to clauses 9.5, 9.8 or 9.10 will allow the other Party a reasonable opportunity to review and comment upon, prior to submission to any Regulatory Authority or Ethics Committee, any response that Party proposes to submit to the relevant Regulatory Authority or Ethics Committee in response to such communication. Each Party will notify the other Party of any meeting or teleconference to be held with any Regulatory Authority relating to a Licensed Product or Combination Product and, to the extent permissible, will allow the other Party or its designee to attend and participate in such meeting or teleconference.

9.10

Emergent shall have the first right to seek, obtain and maintain all Regulatory Approvals reasonably useful or necessary for the Exploitation of Licensed Products and Combination Products in China and India. If Emergent declines to submit, within four (4) years of the date on which the first Marketing Authorisation for any Licensed Product or Combination Product in the Territory is granted, any application for, or other document in support of, a Regulatory Approval, that is reasonably necessary or useful for the Exploitation of Licensed Products and Combination Products in China or India, the Company (or, at its discretion, Aeras) shall be responsible for seeking, obtaining and maintaining such Regulatory Approval in such country. If the Company (or Aeras) seeks any Regulatory Approval in China or India in accordance with this clause 9.10, Emergent shall reimburse the Company (or Aeras) for half of the out-of-pocket expenses incurred by the Company (or Aeras) in connection with the preparation and submission of any application for such Regulatory Approval. Whichever Party is responsible for seeking, obtaining and maintaining Regulatory Approvals in China or India pursuant to this clause 9.10 shall also be responsible for all communications with Regulatory Authorities and Ethics Committees in such country in connection with the Development or Exploitation of Licensed Products or Combination Products in such Country.

9.11

In the event that any Regulatory Authority issues or requests a recall or takes similar action in connection with a Licensed Product or Combination Product, or in the event either Party (or any of its sub-licensees) determines that an event, incident or circumstance has occurred that may result in the need for a recall or market withdrawal of a Licensed Product or Combination Product, the Party notified of or desiring such recall or similar action shall, within twenty four (24) hours, advise the other Party thereof by telephone or facsimile. Following notification of a recall (i) with respect to Licensed Products or Combination Products in the Developing World or in China or India, when the Company (or Aeras) is responsible for obtaining Regulatory Approvals in such country pursuant to clause 9.10, as between the Parties, the Company shall decide in its sole discretion whether to conduct a recall (except in the case of a government mandated recall) and the manner in which any such recall shall be conducted, and (ii) with respect to Licensed Products or Combination Products in the Territory or in China or India, when Emergent is responsible for obtaining Regulatory Approvals in such country pursuant to clause 9.10, Emergent shall decide in its sole discretion whether to conduct a recall (except in the case of a government mandated recall) and the manner in which any such recall shall be conducted. Unless

10

Exploitation

10.1

Emergent shall use its Efforts to Market a Licensed Product (or, if Developed, a Combination Product) in the Field in the Territory.

10.2

Within six (6) months of the Successful Completion Date of the Infant Phase IIb Study, Emergent will deliver to the Company a marketing plan, which will describe Emergent’s planned activities to Market Licensed Products in the Territory.

10.3

Emergent will review and, where appropriate, update the Marketing Plan at least once every Licence Year and will deliver to the Company, not less than one (1) month prior to the commencement date of the revised Marketing Plan, the revised Marketing Plan together with an update on the implementation of the Marketing Plan including what has and has not been achieved since the last written update on the implementation of the Marketing Plan.

10.4

Emergent will use its Efforts to apply for, as promptly as possible, and if the application is accepted use its Efforts to obtain, the Infant Marketing Approval within two (2) years of the Successful Completion Date of the final Phase III Clinical Trial for the Infant Indication. If the Infant Marketing Approval is granted, Emergent will use its Efforts to Market such approved Licensed Product for the Infant Indication in the Field in the Territory.

10.5

If the Infant Marketing Approval is granted, Emergent will, unless otherwise agreed as part of an Approved Alternative Strategy, use its Efforts to apply for, as promptly as possible, and if the application is accepted use its Efforts to obtain, the Adolescent Marketing Approval within two (2) years of the Successful Completion Date of the final Phase III Clinical Trial for the Adolescent Indication. If the Adolescent Marketing Approval is granted, Emergent will use its Efforts to Market such approved Licensed Product for the Adolescent Indication in the Field in the Territory.

10.6

If the Adolescent Marketing Approval is granted, Emergent will, unless otherwise agreed as part of an Approved Alternative Strategy, use its Efforts to apply for, as promptly as possible, and if the application is accepted use its Efforts to obtain, the HIV Marketing Approval within two (2) years of the Successful Completion Date of the final Phase IIb Clinical Trial for the HIV Indication or, if necessary for Marketing Authorisation, the final Phase III Clinical Trial for the HIV Indication. If the HIV Marketing Approval is granted, Emergent will use its Efforts to Market such Licensed Product for the HIV Indication in the Field in the Territory.

10.7

Emergent will use its Efforts to prepare marketing materials and train its own and/or its sub-licensees’ sales staff in good time before the grant of Marketing Authorisation for a Licensed Product in the Territory as reasonably necessary to achieve the Overriding Aims.

10.8

Following commercial launch of the first Licensed Product in the Territory, Emergent shall use its Efforts to increase sales of Licensed Product in the Territory to [**] doses per year.

10.9

The Parties acknowledge that the provisions of clauses 10.5 and 10.6 reflect (i) the current Overall Development Plan, (ii) the Parties’ expectations regarding the Development of the Licensed Product (and in particular the order in which Indications

10.10

Emergent shall have the sole right to select the Trademarks for the marketing and sale of the Licensed Products in the Territory. Emergent shall own such Trademarks and all rights and goodwill with respect thereto.

11

Data

11.1

The Company will communicate all Company New Data to Emergent in writing promptly in accordance with an agreed timetable or failing such agreement as reasonably required by Emergent. The Company will procure that the Company New Data are complete and include, with respect to each clinical trial from which Company New Data are obtained, all completed case report forms and all other clinical trial documentation required to be in the possession of a clinical trial sponsor by Article 15(5) of Directive 2001/20/EC, Article 16 of Directive 2005/28/EC or other relevant Applicable Law and any other clinical trial documentation that is otherwise reasonably requested by Emergent.

11.2

Emergent acknowledges and agrees that, as between the Parties, the Company New Data belong to the Company.

11.3

Emergent will communicate in writing to the Company within a reasonable time all Emergent Data reasonably requested by the Company.

11.4

The Company acknowledges and agrees that, as between the Parties, Emergent Data belong to Emergent.

11.5

Each Party acknowledges that even if Study Subjects are not explicitly identified by name, clinical trial data may not be exempt from applicable data protection rules. The Parties will in relation to any clinical trial involving a Licensed Product or a Combination Product, comply fully with the requirements of Applicable Law relating to the collection and transfer of Study Subject data and implement appropriate quality control and quality assurance procedures having regard to the purpose for which the data are being obtained and further processed, including by obtaining appropriate Study Subject consent.

11.6

Each Party will obtain from each Study Subject, prior to enrolment into, and as a condition of that Study Subject’s participation in, any clinical trial involving a Licensed Product or a Combination Product, his or her consent to:

11.6.1

direct access to his or her medical records;

11.6.2

the processing of data relating to him or her and to the movement of that data to other countries, including countries outside of the EEA; and

11.6.3

the transfer of such data to Emergent, the Company and Isis, and in each case their permitted sub-licensees, and the use of those data in obtaining Regulatory Approvals.

12

Know-how, Improvements and Inventions

12.1

To the extent not previously disclosed, the Company will communicate all Company Know-how and Company Manufacturing Technology in writing to Emergent within a reasonable time of the date on which such Company Know-how or Company Manufacturing Technology was first documented or reported to the Company. Emergent acknowledges and agrees that, as between the Parties, the Company Know-how belongs to the Company; provided that any Know-how conceived, discovered, developed or otherwise made solely by the Company under the Wellcome Grant shall vest in the University and shall be licensed to the Company pursuant to the Isis Licence Agreement.

12.2

Emergent will communicate Emergent ODP Technology and Emergent Manufacturing Technology to the Company as reasonably required in connection with the activities to be performed under the Overall Development Plan or as otherwise reasonably requested by the Company. The Company and Emergent acknowledge and agree that, as between the Parties:

12.2.1

the Emergent Manufacturing Technology belongs to Emergent; and

12.2.2

the Emergent ODP Technology: (i) that is conceived, discovered or otherwise made under the Wellcome Grant shall vest in the University; provided that such rights are licensed to the Company and Emergent pursuant to the Isis Licence Agreement; and (ii) otherwise shall be owned by the Company and licensed to Emergent pursuant to clauses 2.1 and 2.2.

12.3

The Parties agree that as between themselves all Intellectual Property Rights in any Invention conceived, discovered, developed or otherwise made jointly by the Company and an Emergent Company (or their respective sub-contractors) which relates to or is reasonably useful for the Exploitation of a Licensed Product or Combination Product in the Field:

12.3.1

that is made under the Wellcome Grant, shall vest in the University, provided that such rights are licensed to the Company pursuant to the Isis Licence Agreement and to Emergent pursuant to clauses 2.1 and 2.2; and

12.3.2

other than an Invention conceived, discovered, developed or otherwise made under the Wellcome Grant, shall vest in the Company.

12.4

The Parties agree that as between themselves all Intellectual Property Rights in any Invention conceived, discovered, developed or otherwise made jointly by the Company or an Emergent Company (or their respective sub-contractors) which does not relate to or is not reasonably useful for the Exploitation of a Licensed Product or Combination Product in the Field:

12.4.1

that is conceived, discovered, developed or otherwise made under the Wellcome Grant, shall vest in the University provided that such rights are licensed to the Company pursuant to the Isis Licence Agreement and to Emergent as Licensed Technology pursuant to clause 2;

12.4.2

other than an Invention conceived, discovered, developed or otherwise made under the Wellcome Grant, shall vest in the Party better placed to exploit such Invention; provided that if neither Party is better placed to exploit such Invention, all the Intellectual Property Rights in such Invention shall be owned by the Company.

12.5

The Party in whom the Intellectual Property Rights in an Invention vest pursuant to clause 12.3.2 or 12.4.2 shall grant or Emergent shall procure that the relevant Emergent Company shall grant to the assigning Party (or, where the relevant Emergent Company is not Emergent, to Emergent) a non-exclusive, perpetual, royalty-free licence to use all Intellectual Property Rights in the Invention, in the case of any such licence in favour of the Company, to Exploit Licensed Products and Company Combination Products in the Field and in the case of any such licence in favour of Emergent, for any purpose; and on assignment in accordance with clause 12.10 the Parties shall enter into a revenue sharing agreement that reflects the relative inventive contributions of each Party to such Invention.

12.6

Subject to clause 12.7, but notwithstanding any other provision in this clause 12, the Parties agree as between themselves that any Manufacturing Technology conceived, discovered, developed or otherwise made jointly by the Company and an Emergent Company in the performance of activities under the Overall Development Plan:

12.6.1

that are conceived, discovered, developed or otherwise made under the Wellcome Grant, shall vest in the University, provided that such rights are licensed to the Company pursuant to the Isis Licence Agreement and to Emergent pursuant to clauses 2.1 and 2.2; and

12.6.2

other than Manufacturing Technology conceived, discovered, developed or otherwise made under the Wellcome Grant, shall, subject to clause 12.7, vest in the Company.

12.7

Where any Manufacturing Technology is the subject of a patent or patent application Controlled by Emergent (a “ Manufacturing Patent ”) the Parties agree that, as between themselves, any development of the Manufacturing Technology made by the Company, an Emergent Company, or an Emergent Company jointly with the Company, in the performance of the Overall Development Plan which would, if commercially practised, infringe and/or be dominated by or rendered unpatentable by that Manufacturing Patent, shall:

12.7.1

if made under The Wellcome Grant, vest in the University provided that such rights are licensed to the Company pursuant to the Isis Licence Agreement and Emergent pursuant to clauses 2.1 and 2.2; and

12.7.2

if not made under the Wellcome Grant, vest in Emergent (an “ Emergent Improvement ”).

12.8

Unless otherwise agreed by the Parties, any data, protocols, standard operating procedures and written documentation prepared jointly by the Company and an Emergent Company in the performance of activities under the Overall Development Plan:

12.8.1

that is made under the Wellcome Grant, shall vest in the University, provided that such rights are licensed to the Company pursuant to the Isis Licence Agreement and to Emergent pursuant to clause 2.1; and

12.8.2

other than works made under the Wellcome Grant, shall vest in the Company; provided that such data, protocols, standard operating procedures and written documentation shall constitute Company New Data and in addition to the rights granted pursuant to clause 2.3, Emergent shall have a royalty free, non-exclusive, worldwide perpetual, irrevocable licence (with the right to sub-license through multiple tiers) to access, reference and otherwise use and reproduce such Company New Data for any purpose.

12.9

If and to the extent that any Intellectual Property Rights (including Manufacturing Technology) conceived, discovered, developed or otherwise made (i) solely by Emergent or (ii) jointly by the Company and one or more Emergent Companies, vest in the Company pursuant to this clause 12, Emergent shall have a non-exclusive, perpetual, irrevocable, worldwide, royalty-free licence (with the right to grant sub-licences without the consent of or accounting to the Company) to practice, access, reference, reproduce and otherwise use such Intellectual Property Rights for any purpose.

12.10

Each of the Parties shall, and does hereby, assign and shall cause its employees, affiliates, sub-contractors and sub-licensees (and their respective employees) to assign to the other, such right, title and interest in and to any Intellectual Property Rights, as is necessary to fully effect the ownership provisions set out in this clause 12. If and to the extent that such Intellectual Property Rights are Know-How, the transferring Party shall treat such Know-How as if it were the Confidential Information of the other Party and shall not use or disclose such Know-How except as permitted by this agreement.

12.11

As between the Parties, for the purpose of allocating ownership of Intellectual Property Rights in accordance with this Agreement, the determination of whether Intellectual Property Rights are conceived, discovered, developed or otherwise made by a Party shall be made in accordance with English law.

13

Patent Filing and Maintenance

13.1

Emergent will pay the Company the Past Patent Costs, representing Emergent’s sole contribution to the patent costs incurred by the Company prior to the Parties entering into this agreement, within thirty (30) days of the later of receipt of an invoice for the same from the Company and the Effective Date.

13.2

Subject to the remainder of this clause 13, the Company will, at Emergent’s cost, prosecute, defend, maintain and renew the Company Patent Rights in the countries in

13.2.1

the Company Patent Rights can no longer be renewed;

13.2.2

the Company is advised by patent counsel that there is no further principled argument to be advanced in favour of patentability;

13.2.3

there is no reasonable prospect of obtaining a Marketing Authorisation for any Licensed Product for any Indication in the relevant country;

13.2.4

Emergent and, in the case of any Isis Application, Isis consent, such consent not to be unreasonably withheld, conditioned or delayed, that the Company may discontinue pursuit of the Company Patent Rights; or

13.2.5

Emergent and the Company and, in the case of any Isis Application, Isis agree to discontinue pursuit of the Company Patent Rights;

13.3

In relation to the prosecution, defence, maintenance and renewal of the Company Patent Rights, the Company will:

13.3.1

use patent professionals reasonably acceptable to Emergent;

13.3.2

keep Emergent fully informed of all material developments, consult fully with Emergent in relation to all material matters of tactics and strategy and will in good faith take account of any comments of the Company, in particular before taking any material patenting decisions, and will give Emergent adequate advance notice of its intention to file any Company Patent Rights, to designate any country in Company Patent Rights, or to take any material decision in relation to Company Patent Rights (before or after grant), and will provide copies of all relevant documents to Emergent;

13.3.3

as reasonably necessary to allow Emergent to exercise its rights pursuant to clause 13.3.2, allow representatives from Emergent and any professional advisors of Emergent to attend any meetings with the Company’s patent professionals in person or by telephone and will arrange additional meetings with Emergent’s patent professionals as and when reasonably requested by Emergent, at the expense of Emergent;

13.3.4

provide Emergent with adequate notice of any formal hearings or other proceedings which the Company is entitled to attend and will permit representatives of Emergent to attend as well;

13.3.5

disclose to the United States Patent and Trademark Office (and where required by Applicable Law, its equivalent in any jurisdiction) any information considered material for patentability as required by 37 C.F.R. § 1.56 (or the equivalent in any jurisdiction) and, if Emergent has any

13.3.6

provide (or procure that its patent professionals will provide) copies of all official correspondence to and from patent offices relating to the Licensed Technology to Emergent (including renewal notices) within fourteen (14) days of dispatch or receipt;

13.4

If, with respect to the Company Patent Rights, the Company intends not to (i) pursue in any country the filing, prosecution (including any interferences, re-issue proceedings and re-examination) or maintenance (including the defence of oppositions) of an Isis Application, or (ii) take any other action with respect to Company Patent Rights in a country that is necessary or useful to establish or preserve rights thereto, in either case as permitted by clause 13.2, then the Company shall so notify Emergent and, if related to the Isis Application, Isis, promptly in writing to enable Emergent, subject to, with respect to an Isis Application, Isis’s prior written consent (such consent not to be unreasonably withheld, delayed or conditioned) to meet any deadline by which an action must be taken to establish or preserve any rights in the Patent Rights, as applicable, in such country; provided, however, that any such notification shall be made at least thirty (30) days prior to such deadline. Emergent shall, subject to, with respect to an Isis Application, Isis’s prior written consent (such consent not to be unreasonably withheld, delayed or conditioned), have the right, but not the obligation, to pursue the filing or registration, or support the continued prosecution or maintenance, of such Company Patent Rights in such country through patent attorneys or agents of its choice. If Emergent elects to pursue such filing or registration, as the case may be, or continue such support, then Emergent shall notify the Company of such election.

13.5

If, at any time, the Company is unwilling to prosecute or maintain Company Patent Rights as required pursuant to clause 13.2, Emergent will consider in good faith the Company’s reasons for wishing to allow such Patent Rights to lapse in the country in question. If there is a dispute as to whether the Company is permitted to allow any Patent Rights to lapse pursuant to clause 13.2, such dispute shall be determined by an Expert. If the dispute involves an Isis Application, Isis shall participate in such determination. If the expert determines that the Company is not entitled to allow an Isis Application to lapse, Emergent shall be entitled, and Isis and the Company shall permit Emergent to assume responsibility for such prosecution and maintenance in that country.

13.6

The Parties acknowledge that if Isis or the University grants a Third Party a licence under the Isis Application in all or part of the Territory which includes exclusive rights to commercialise a product (that is not a Licensed Product), with effect from the date of such licence, the Company shall only be required to pay for half of the external legal costs and expenses reasonably incurred in the prosecution, defence or maintenance of any Isis Application in the territory in which the Third Party is granted a licence which claim such product and the Licensed Product. In such circumstances, the amount payable by Emergent in respect of patent costs pursuant to clause 13.2 shall be

13.7

The Parties and Isis shall cooperate with each other in obtaining patent term restoration or supplemental protection certificates or their equivalents relating to the Company Patent Rights (“ Patent Extensions ”). In the event that elections with respect to obtaining such Patent Extensions are to be made, Emergent shall have the right to make the election and the Company and Isis agree to abide by such election and take such actions as Emergent may require in connection with securing such Patent Extensions. Neither the Company nor Isis shall seek to obtain any other Patent Extension for the Company Patent Rights with respect to a Licensed Product or any other product without Emergent’s prior consent.

13.8

Where reasonably necessary under the law of any country, Emergent will use its Efforts to register its interest in the Licensed Technology with the relevant patent office (or equivalent) in that country. The Company will, at the Licensee’s request and expense, take all actions (including using its reasonable endeavours to procure any necessary Third Party’s consent) and execute all deeds and documents that may be reasonably necessary in connection with such registration.

14

Enforcement and Defence

14.1

Each Party will notify the other in writing of any misappropriation or infringement of any Intellectual Property Rights in the Licensed Technology of which it becomes aware.

14.2

The Company has the first right (at its cost and expense) to, and shall at Emergent’s request (and at Emergent’s cost and expense), take legal action against any misappropriation or infringement of any rights included in the Licensed Technology in the Field in the Territory. The Company must discuss any proposed legal action, other than emergency actions, with Emergent prior to the legal action being commenced and the Parties shall consider in good faith what action is appropriate in all the circumstances. Emergent may, in its sole discretion (at its cost and expense), and shall at the Company’s request (at the Company’s cost and expense), join the action as a party; provided that Emergent shall not be required to join any such action unless:

14.2.1

the Company has a bona fide legal action against a third party for misappropriation or infringement of any rights included in the Licensed Technology; and

14.2.2

on balance, with due regard for all relevant circumstances, including Applicable Law, the Company has a more than fifty (50%) percent chance of success in such action (and if the parties do not agree on the likely chance of success either may refer the dispute to an expert in accordance with clause 22.14; provided that in such circumstances the expert shall be an independent lawyer of at least ten (10) years’ standing in contentious patent matters);

14.2.3

the Company cannot achieve the same result by bringing the legal action under a different law or in a different jurisdiction; and

14.2.4

in order to bring the action, as a matter of law, Emergent is required to be a party.

14.3

With respect to any action pursuant to clause 14.2, the Company will:

14.3.1

keep Emergent fully informed and consult with Emergent at each stage of the legal action;

14.3.2

use legal counsel reasonably acceptable to Emergent;

14.3.3

save with the prior written consent of Emergent, such con