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BLAKE DAWSON WALDRON L A W Y E R S Licence Agreement Novogen Research Pty Limited ABN 87 060 202 931 Marshall Edwards Pty Limited ABN 36 099 665 675 CONTENTS 1. INTERPRETATION 1 1.1 Definitions 1 1.2 Rules for interpreti

Tuesday, May 16, 2006 1 min read
Key Takeaway: BLAKE DAWSON WALDRON L A W Y E R S Novogen Research Pty Limited Marshall Edwards Pty Limited 1. INTERPRETATION 1 1.1 Definitions 1 1.2 Rules for interpreting this document 8 1.3 Business Days 9 2. LICENCE 9 2.1 Grant of licence 9

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BLAKE DAWSON WALDRON
L A W Y E R S
Novogen Research Pty Limited
Marshall Edwards Pty Limited
1. INTERPRETATION 1
1.1 Definitions 1
1.2 Rules for interpreting this document 8
1.3 Business Days 9
2. LICENCE 9
2.1 Grant of licence 9
2.2 Expiration of particular Licensed Patent Rights 9
2.3 Research licence 10
2.4 Sub-licences 10
2.5 Sub-contractors 11
2.6 No Exploitation outside the Field 11
2.7 Acknowledgements and reserved rights 11
2.8 Delivery up of Know How and Clinical Trial Materials 12
3. EXISTING AGREEMENTS 12
3.1 Existing Agreements 12
3.2 Acknowledgement by MEPL 12
3.3 Completion or novation 12
3.4 Licence for Existing Agreements 13
3.5 Performance of and payments under Existing Agreements 13
4. CLINICAL TRIALS 13
4.1 Clinical Trials to date 13
4.2 Obligation to conduct Clinical Trials 14
4.3 Conduct of Clinical Trials 14
4.4 Clinical Trial Materials 14
4.5 Records of Clinical Trials 14
4.6 Inspection of records 15
4.7 Reports on Clinical Trials 15
4.8 Publication of results of Clinical Trials 15
4.9 Intellectual Property Rights in Clinical Trial Materials 15
5. DEVELOPMENTS 16
5.1 MEPL Developments 16
5.2 Novogen Developments 16
6. MARKETING AND COMMERCIALISATION 16
6.1 Marketing and commercialisation 16
6.2 Diligence 16
6.3 Milestones 16
6.4 Revision of Milestones 17
6.5 Continuing obligation 17
6.6 Records and customer relations 17
6.7 Marketing and promotion 17
6.8 Marketing and distribution plan 18
6.9 Storage and handling 18
6.10 Manufacturing of Licensed Products 18
7. LICENCE FEES AND ROYALTIES 19
7.1 Up-front licence fee 19
7.2 Milestone licence fees 19
7.3 Payments upon default of milestones 19
7.4 Default by a Novogen Company 20
7.5 Royalties 20
7.6 Minimum royalties 20
7.7 How payments must be made 21
7.8 Deductions and withholdings 21
7.9 Interest on overdue amounts 22
8. REPORTS AND ACCOUNTING 22
8.1 Books and records 22
8.2 Auditor s certificates 22
8.3 Inspection 23
8.4 Quarterly statements 23
8.5 Certification 23
8.6 Adjustments 24
9. OTHER COSTS 24
9.1 Maintenance of Licensed Patent Rights 24
9.2 Reimbursement by MEPL 24
9.3 Consultation on maintenance of Licensed Patent Rights 24
9.4 Withdrawal or lapsing of Licensed Patent Rights 25
9.5 Registration of Licensed Products 25
10. INTELLECTUAL PROPERTY RIGHTS 26
10.1 Acknowledgment 26
10.2 Maintenance of Licensed Intellectual Property 26
10.3 Notification 26
10.4 Proceedings by MEPL 26
10.5 Joinder of Novogen Research 26
10.6 Proceedings by Novogen Research 26
10.7 Joinder of MEPL 27
10.8 Damages and settlement amounts 27
10.9 Assignment of Intellectual Property Rights 27
10.10 Infringements by MEPL 27
11. CONFIDENTIAL INFORMATION 28
11.1 Use by MEPL for Exploitation 28
11.2 Confidentiality 28
11.3 Security 28
11.4 Exceptions to obligations of confidentiality 28
11.5 Public domain 28
12. REPRESENTATIONS AND WARRANTIES 29
12.1 Warranties by each party 29
12.2 Representations and warranties by Novogen Research 30
12.3 Validity of Licensed Patent Rights 31
12.4 Exclusion of conditions and warranties 31
12.5 Reliance on representations and warranties 31
13. LIMITATION OF LIABILITY 31
13.1 Limitation of liability of Novogen Research 31
13.2 Liability for breach of certain warranties 31
13.3 Indirect and consequential loss 32
14. INDEMNITIES 32
14.1 Clinical Trial indemnity 32
14.2 Commercialisation indemnity by MEPL 32
15. INSURANCE 33
15.1 MEPL s insurance policies 33
15.2 Name of Novogen Research 33
15.3 Certificates of currency 33
15.4 Default 33
15.5 Expiry 33
15.6 Novogen Research s insurance 33
16. FORCE MAJEURE 33
16.1 Notice and suspension of obligations 33
16.2 Effort to overcome 34
16.3 Termination 34
17. TERM AND TERMINATION 34
17.1 Term 34
17.2 Termination by Novogen Research 34
17.3 Termination by Novogen Research as to a particular Compound 35
17.4 Termination by MEPL 35
17.5 Termination by MEPL as to a particular Compound 36
17.6 Confidential Information 36
17.7 Consequences to MEPL of termination 36
17.8 Existing contracts 37
17.9 Survival and accrued rights 37
18. DISPUTE RESOLUTION 37
18.1 Disputes 37
18.2 Notice of Dispute 37
18.3 Negotiation 38
18.4 Resolution of Dispute 38
18.5 Mediation 38
19. NOTICES 38
19.1 Notices 38
19.2 Addresses for notices 38
20. AMENDMENT AND ASSIGNMENT 39
20.1 Amendment 39
20.2 Assignment 39
21. GENERAL 39
21.1 Governing law 39
21.2 Liability for expenses 39
21.3 Relationship of the parties 39
21.4 Giving effect to this document 39
21.5 Waiver of rights 39
21.6 Operation of this document 40
21.7 Operation of indemnities 40
21.8 GST gross up and GST on claims 40
21.9 Consents 41
21.10 Exclusion of contrary legislation 41
21.11 Inconsistency with other documents 43
21.12 Counterparts 43
Schedules
1 LICENSED PATENT RIGHTS 42
2 COMPOUNDS 43
3 EXISTING AGREEMENTS 44
Novogen Research Pty Limited ABN 87 060 202 931 of 140 Wicks Road, North
NSW 2113 Australia (Novogen Research)
Edwards Pty Limited ABN 36 099 665 675 of 140 Wicks Road, North
A. Novogen Research and MEPL are parties to the Amended and Restated Licence Option Deed.
B. The compounds known as NV-196 and NV-143 are Option Compounds.
C. MEPL wishes to exercise the option granted to it in clause 3 of the Amended and Restated Licence Option Agreement with respect to NV-196 and NV-143 and acquire an exclusive licence to Exploit Licensed Products in the Field on the terms and conditions of this document.
D. Novogen Research agrees to grant that licence on the terms and conditions of this document.
OPERATIVE PROVISIONS
The following definitions apply in this document.
Accountant has the meaning given in clause 8.5(a).
Affiliate means:
(i) that body s related bodies corporate;
(ii) that body s directors; and
(iii) the persons who have a substantial holding (as that term is defined in the Corporations Act) in that body; and
(ii) relative by blood or adoption of that person or that person s spouse; and
(iii) body corporate in which that person and Affiliates of that person hold in aggregate more than 20% of the voting shares.
Amended and Restated Licence Option Deed means the agreement of that title between Novogen Research and MEPL dated 24 September 2003.
Authorisation means:
(a) an authorisation, consent, declaration, exemption, notarisation or waiver, however it is described; and
(b) in relation to anything that could be prohibited or restricted by law if a Government Agency acts in any way within a specified period, the expiry of that period without that action being taken,
including any renewal or amendment.
Business Day means a day that is not a Saturday, Sunday or public holiday in Sydney, Australia.
Certification has the meaning given in clause 8.5(d).
Change of Control of MEPL means:
(a) the acquisition, by any person or group of more than 50% of the combined voting power of the then outstanding securities entitled to vote generally in the election of directors of MEPL; or
(b) any merger, consolidation, reorganization, recapitalization, tender or exchange offer or any other transaction with or effecting MEPL as a result of which a person or group other than the shareholders of MEPL immediately before the transaction owns after the transaction more than 50% of the combined voting power of the then outstanding securities entitled to vote generally in the election of the directors of MEPL,
but does not occur by reason only of an issue of, acquisition of, or transaction involving, MEI s securities.
Clinical Trial means a clinical evaluation of the stability, safety or efficacy of a Licensed Product for use in the Field involving administration of the Licensed Product to humans.
Clinical Trial Materials means all past, current and future Trial Protocols, data and results of Clinical Trials, patient enrolment and consent forms, case report forms, study aids, and any other documents (in any form or media) used in or in connection with, or arising out of, the conduct of Clinical Trials.
Clinical Trial Subject means a person enrolled at any time in a Clinical Trial (whether or not that person meets all eligibility criteria for enrolment into the Clinical Trial set out in any Trial Protocol or otherwise).
Commencement Date means the date this document is executed by the last of the parties to execute it.
Commercialisation Income means all gross income received by or on behalf of MEPL or any MEI Company from a third party (not being an MEI Company) as a result of or in connection with any assignment, sublicensing, or other dealing with MEPL s rights under this document, other than:
(a) income comprising Net Sales of Licensed Products; or
(b) royalties paid to MEPL on Net Sales of Licensed Products.
(i) was in the public domain when it was given to MEPL;
(ii) becomes, after being given to MEPL, part of the public domain, except through disclosure contrary to this document: or
(iii) was lawfully received by MEPL from another person having the unrestricted legal right to disclose that information without requiring the maintenance of confidentiality; and
(i) was in the public domain when it was given to Novogen Research;
(ii) becomes, after being given to Novogen Research, part of the public domain, except through disclosure contrary to this document; or
(iii) was lawfully received by Novogen Research from another person having the unrestricted legal right to disclose that information without requiring the maintenance of confidentiality.
Corporations Act means the Corporations Act 2001 (Cth).
Diligent Efforts, in relation to any obligation of a party, means the level of efforts required to carry out that obligation in a sustained manner consistent with the efforts a reasonable person in the same position would devote to a product of high market potential, profit potential or strategic value, based on conditions then prevailing. This requires that the party:
(a) promptly assign responsibility for such obligations to specific employees, contractors or agents who are held accountable for progress and monitor progress on an on-going basis;
(b) set and consistently seek to achieve specific and meaningful objectives for carrying out such obligations; and
(c) consistently make and implement decisions and allocate resources designed to advance progress on such objectives.
Disclosing Party in relation to any information means the party who disclosed that information to another party.
Dispute has the meaning given to that term in clause 18.1.
Dispute Notice has the meaning given to that term in clause 18.2.
Encumbrance means a mortgage, charge, pledge, lien, hypothecation or title retention arrangement, a right of set-off or right to withhold payment of a deposit or other money, a notice under section 255 of the Income Tax Assessment Act 1936 (Cth), subdivision 260-A in schedule 1 to the Taxation Administration Act 1953 ( Cth) or any similar legislation, or an easement, restrictive covenant, caveat or similar restriction over property, or an agreement to create any of them or to allow any of them to exist.
Existing Agreements means the agreements set out in Schedule 3.
Exploit means:
(a) in relation to a product or substance, to make, sell, supply, hire or otherwise dispose of the product, offer to make, sell, supply, hire or otherwise dispose of it, use or import it, or keep it for the purpose of doing any of those things; and
(b) in relation to a method or process, to use the method or process or do any of the actions in paragraph (a) in respect of an item resulting from such use.
Field means the prevention, treatment or cure of cancer in humans (which does not include purely benign conditions) by pharmaceuticals delivered or administered by injection or any other means other than Topical Application.
Force Majeure Event means an act of war (whether declared or not) or terrorism, the mobilisation of armed forces, insurrection, civil commotion or riot, natural disaster, lightning, explosions, flood, subsidence, industrial action or labour disturbance, currency restriction, embargo, action or inaction by a Government Agency, or a failure of a supplier, public utility or common carrier or any other event beyond the reasonable control of the affected party.
Government Agency means:
(a) a government or government department or other body;
(b) a governmental, semi-governmental or judicial person; or
Infringement Claim has the meaning given in clause 10.10.
Insolvency Event means, in relation to a person, being in liquidation or provisional liquidation or under administration, having a controller (as defined in the Corporations Act) or analogous person appointed to it or any of its property, being taken under section 459F(1) of the Corporations Act to have failed to comply with a statutory demand, being unable to pay its debts or otherwise insolvent, dying, ceasing to be of full legal capacity or otherwise becoming incapable of managing its own affairs for any reason, taking any step that could result in the person becoming an insolvent under administration (as defined in section 9 of the Corporations Act), entering into a compromise or arrangement with, or assignment for the benefit of, any of its members or creditors, or any analogous event.
Intellectual Property Rights means any and all existing and future intellectual and industrial property rights throughout the world, whether conferred by statute, common law or equity, including rights in relation to copyright, trade marks, designs, circuit layouts, plant varieties, business and domain names, trade secrets, Patent Rights and rights to require that Know How be kept confidential (including the right to apply for registration of any such rights) and other results of intellectual activity in the industrial, commercial, scientific, literary or artistic fields.
Know How means technical and other information which is not in the public domain, including inventions, discoveries, concepts, data, formulae, ideas, specifications, procedures for experiments and tests, results of experimentation and testing, results of research and development and information in laboratory records, Clinical Trial Materials, case reports, data analyses and summaries and submissions to and information from ethics committees and Government Agencies.
Licensed Intellectual Property means the Licensed Patent Rights and the Intellectual Property Rights in the Licensed Know How.
Licensed Know How means:
(a) all Know How of a Novogen Company directly relating to the synthesis, manufacture, uses, applications, reduction to practice or clinical research and development in the Field, of the Compounds (and not any other compound) or of any actual or potential Licensed Products as at the Commencement Date; and
(b) all Know How in Novogen Developments and MEPL Developments; and
(c) all Know How of a Novogen Company in and in relation to Clinical Trial Materials.
Licensed Patent Rights means all existing and future Patent Rights in the patents and patent applications set out in Schedule 1, all Patent Rights in any Novogen Developments and all Patent Rights in any MEPL Developments.
Licensed Product means any product or formulation containing one or more Compounds for use in the Field which:
(a) falls within the scope of a Valid Claim or in which a Compound falls within the scope of a Valid Claim; or
(b) uses, reproduces or applies any Licensed Know How, or the development or manufacture of which involved the use, reproduction or application of any Licensed Know How.
MEI means Marshall Edwards, Inc., a company incorporated under the laws of Delaware, United States of America, c/- The Corporation Trust Company, Corporation Trust Center, 1209 Orange Street, Wilmington, Delaware, USA.
MEI Company means MEPL, MEI and any of its subsidiaries.
MEPL Developments means all developments of, improvements to, enhancements to, or adaptations of Licensed Products or the Licensed Know How, whether patentable or otherwise, which during the Term are made or acquired by MEPL or any MEI Company or their employees, contractors or agents, but does not include any new isoflavonoid compound having a formula which does not fall within the claims of the Licensed Patent Rights.
Milestone Licence Fees means the fees set out in clause 7.2(b).
Milestones means the milestones set out in clause 6.3.
Minimum Royalty has the meaning given in clause 7.6(a).
Net Sales in relation to any Licensed Product means the gross amount actually received by MEPL or any sublicensees for that Licensed Product (whether in combination with any other compound or component, active or otherwise) sold, supplied, hired or otherwise disposed of by MEPL or any sublicensee to the first person who is not an MEI Company or sublicensee, after deducting (to the extent not already deducted):
(a) freight, packing and insurance costs included in the invoice or price;
(b) returns, rebates and allowances and discounts actually taken;
(c) any GST, value added Tax or similar Tax levied on the sale or supply of Licensed Products borne by an MEI Company.
NV-143 means an isoflavonoid compound of the formula II in Schedule 2 (known as the compound NV-143) and any Pharmaceutically Acceptable Salt of that compound.
NV-196 means an isoflavonoid compound of the formula I in Schedule 2 (known as the compound NV-196) and any Pharmaceutically Acceptable Salt of that compound.
Novogen Companies means Novogen Limited, Novogen Research and Novogen Laboratories.
Novogen Developments means all developments of, improvements to, enhancements to, or adaptations of Licensed Products or Licensed Know How, whether patentable or otherwise, in the Field which during the Term are made or acquired by a Novogen Company or their employees, contractors or agents, which Novogen Research is free to license or disclose to
MEPL, but does not include any Option Compound (other than NV-196 and NV-143) or any new isoflavonoid compound having a formula which does not fall within the claims of the Licensed Patent Rights.
Novogen Laboratories means Novogen Laboratories Pty Limited ABN 42 002 489 947.
Novogen Limited means Novogen Limited ABN 37 063 259 754.
Option Compound has the meaning given in the Amended and Restated Licence Option Deed.
Patent Rights means rights with respect to existing and future patents (including any divisions, continuations, continuations in part, renewals, reissues, extensions, supplementary protection certificates, utility models and foreign equivalents of any such patents) and rights with respect to existing and future patent applications and patentable inventions, including the right to apply for registration of any such rights.
Pharmaceutically Acceptable Salt has the meaning given in Schedule 2.
Phase I Clinical Trial means a Clinical Trial in any country intended to obtain data regarding safety and pharmacokinetics of a Licensed Product that would satisfy the requirements of the United States Code of Federal Regulations 21 CFR 312.21(a) or any corresponding law in another country.
Phase II Clinical Trial means a Clinical Trial in any country intended to evaluate the safety, dose range and efficacy of a Licensed Product for a particular indication or indications in human subjects with the disease or indication under study or that would otherwise satisfy the requirements of the United States Code of Federal Regulations 21 CFR 312.21(b) or any corresponding law in another country but does not include a Phase III Clinical Trial.
Phase III Clinical Trial means a Clinical Trial that is a pivotal human clinical trial in any country the results of which could be used to establish statistical safety and efficacy of a Licensed Product as a basis for a New Drug Approval (NDA) or that would otherwise satisfy the requirements of the United States Code of Federal Regulations 21 CFR 312.21(b) or any corresponding law in another country.
Quarter means, in respect of any calendar year in the Term, the four quarters of that year, the first of which commences on 1 January of that year.
St George Clinical Trial has the meaning given in clause 4.1(a).
Tax means a tax, levy, duty, charge, deduction or withholding, however it is described, that is imposed by law or by a Government Agency, together with any related interest, penalty, fine or other charge, other than one that is imposed on net income in any jurisdiction.
Term means the term of this document as determined under clause 17.
Territory means the world.
Third Party Licence has the meaning given in clause 10.10(b).
Topical Application in respect of any product, means application of the product to the external surface of the skin by any means.
Trial Protocol means a protocol for the conduct of a Clinical Trial.
Valid Claim means:
(i) a claim which has been revoked by a decision of a Government Agency or court of competent jurisdiction from which no appeal lies or in respect of which no appeal has been filed within the time allowed; or
(ii) a claim which has been admitted by Novogen Research to be invalid or unenforceable, through reissue or otherwise; or
1.2 Rules for interpreting this document
(i) legislation (including subordinate legislation) is to that legislation as amended, re-enacted or replaced, and includes any subordinate legislation issued under it;
(ii) a document or agreement, or a provision of a document or agreement, is to that document, agreement or provision as amended, supplemented, replaced or novated;
(iii) a party to this document or to any other document or agreement includes a permitted substitute or a permitted assign of that party;
(iv) a person includes any type of entity or body of persons, whether or not it is incorporated or has a separate legal identity, and any executor, administrator or successor in law of the person; and
(v) anything (including a right, obligation or concept) includes each part of it.
(b) A singular word includes the plural, and vice versa.
(c) A word which suggests one gender include the other genders.
(d) If a word is defined, another part of speech has a corresponding meaning.
(e) If an example is given of anything (including a right, obligation or concept), such as by saying it includes something else, the example does not limit the scope of that thing.
(f) The word agreement includes an undertaking or other binding arrangement or understanding, whether or not in writing.
(g) The words subsidiary, holding company and related body corporate have the same meanings as in the Corporations Act.
(h) A reference to US$ is to the currency of the United States of America.
(a) if the act involves a payment that is due on demand, the person must do it on or by the next Business Day; and
(b) in any other case, the person must do it on or by the previous Business Day.
2.1 Grant of licence
(a) Exploit Licensed Products in the Territory for use in the Field;
(b) use, reproduce and apply the Licensed Know How in the Territory in the Field for the purpose of Exploiting Licensed Products in the Field; and
(c) develop, modify and enhance the Licensed Know How in the Territory for the purpose of Exploiting Licensed Products in the Field.
2.2 Expiration of particular Licensed Patent Rights
(a) subject to clause 17.1, the licence granted in clause 2.1 applies and continues in full force and effect in that country for the Term on the same terms as a licence under the Intellectual Property Rights in the Licensed Know How only; and
(b) the royalty rate specified in clause 7.5(a) payable on Licensed Products which are entirely manufactured and supplied in such a country (or countries) will be reduced by 50% of the rate specified in clause 7.5(a).
2.3 Research licence
(i) conduct its own research and development on and in relation to any Licensed Product; and
(ii) use, reproduce, apply, develop, modify and enhance the Licensed Know How for the purpose of conducting its own research and development on and in relation to any Licensed Product.
(a) Subject to paragraphs (b), (c) and (d), MEPL may not grant sub-licences under any of the rights granted to it under this document without the prior written consent of Novogen Research.
(b) MEPL may grant sub-licenses under the rights granted to it in clause 2.1 to third parties to manufacture and supply to MEPL all or part of the Licensed Products without the consent of Novogen Research.
(c) MEPL may grant sub-licenses under the rights granted to it in clause 2.1 to its related bodies corporate without the consent of Novogen Research.
(d) If MEPL wishes to grant any sub-licence under any of the rights granted to it under this document other than as permitted in paragraph (b) and (c):
(i) MEPL must request the consent of Novogen Research in writing, stating the identity of the proposed sub-licensee and providing a copy of the proposed sub-licence agreement;
(ii) Novogen Research must provide or decline its consent in writing within 30 days of MEPL s request, providing reasons;
(iii) if Novogen Research wishes to decline its consent, it must first engage in discussions with MEPL (for no more than 21 days) to attempt to resolve any reasonable concerns it has with respect to the proposed sub-licence or sub-licensee with a view to determining if those concerns can be overcome by appropriate amendment of the proposed sub-licence arrangements; but
(iv) Novogen Research must not unreasonably withhold its consent.
(ii) ensure that any sub-licence granted under this clause 2.4 contains obligations of the sub-licensee with respect to confidentiality of Novogen s Confidential Information at least as onerous as the obligations of MEPL under this document.
(iii) ensure that any sub-license granted under this clause 2.4 is expressed to terminate immediately upon termination of this document; and
(iv) provide to Novogen Research a complete copy of any executed sub-licence agreement within 21 days of its execution.
(a) MEPL may sub-contract the manufacture and supply to MEPL of all or part of the Licensed Products without the consent of Novogen Research. Such sub-contracts must be granted on terms which are consistent with this document and do not relieve MEPL of its obligations under this document.
(b) Except as provided in clause 2.4 and 2.5(a), MEPL may not engage agents or contractors to perform its obligations under this document unless such agents or sub-contractors first agree in writing:
(i) to comply with confidentiality obligations substantially identical to those of MEPL under this document; and
(ii) to assign to MEPL all Intellectual Property Rights in the Field created or acquired by them in the course of their engagement.
2.6 No Exploitation outside the Field
(a) Exploit Licensed Products outside the Field; or
(b) market, advertise, promote or Exploit Licensed Products to any person who MEPL knows or suspects will or is likely to Exploit the Licensed Products outside the Field.
2.7 Acknowledgements and reserved rights
(a) that Novogen Research remains the legal and beneficial owner of the Licensed Intellectual Property and nothing in this document effects an assignment or transfer to MEPL of the Licensed Intellectual Property;
(b) that nothing in this document prevents Novogen Research and its Affiliates (other than MEPL or MEI) from Exploiting any product or process outside the Field; and
2.8 Delivery up of Know How and Clinical Trial Materials
3. EXISTING AGREEMENTS
3.1 Existing Agreements
(a) that Novogen Research is a party to Existing Agreements 2 to 6 (inclusive);
(b) that Novogen Limited is a party to Existing Agreement 1;
(c) that obligations under each of the Existing Agreements remain to be performed;
(d) that neither Novogen Research nor Novogen Limited is in breach of its obligations under any Existing Agreement; and
(c) that to its knowledge no other party is in breach of its obligations under any Existing Agreement.
3.2 Acknowledgement by MEPL
3.3 Completion or novation
(a) that Novogen Research shall continue to exercise its rights and perform its obligations under Existing Agreements 4 and 6 until the rights and obligations of Novogen Research under each of those Existing Agreements with respect to the Compounds are novated to MEPL as soon as reasonably practicable on reasonable terms agreed by the parties and the other parties to each of those Existing Agreements;
(b) that Novogen Limited shall continue to exercise its rights and perform its obligations under Existing Agreement 1 until the rights and obligations of Novogen Limited under that Existing Agreement with respect to the Compounds are novated
to MEPL as soon as reasonably practicable on reasonable terms agreed by the parties and the other parties to that Existing Agreement; and
(c) that Novogen Research shall continue to exercise its rights and perform its obligations under Existing Agreements 2, 3 and 5 until completion of those Existing Agreements.
3.4 Licence for Existing Agreements
(i) the novation to MEPL of the rights and obligations of Novogen Research (or Novogen Limited as the case may be) under the Existing Agreement with respect to the Compounds; and
(ii) the completion of the Existing Agreement with respect to the Compounds.
3.5 Performance of and payments under Existing Agreements
(a) Novogen Research shall use reasonable endeavours (and shall procure that Novogen Limited uses reasonable endeavours) not to breach any obligation under the Existing Agreement; and
(b) MEPL shall reimburse Novogen Research the full amount of any payment made by Novogen Research or Novogen Limited under the Existing Agreement, within 21 days of the payment being made.
4.1 Clinical Trials to date
(a) Novogen Laboratories sponsored and funded a Phase 1 Clinical Trial in Australia at the St George Hospital (the St George Clinical Trial ) before the Commencement Date;
(b) Novogen Laboratories obtained the approval of the relevant Human Research Ethics Committee (HREC) to conduct the St George Clinical Trial; and
(c) the St George Clinical Trial has completed.
4.2 Obligation to conduct Clinical Trials
4.3 Conduct of Clinical Trials
(a) fund or arrange adequate third party funding of Clinical Trials;
(b) use Diligent Efforts to design and conduct Clinical Trials to generate outcomes which are calculated to result in marketing approval of a Licensed Product for use in the Field;
(c) conduct Clinical Trials diligently, in good scientific manner and in compliance with any applicable laws and requirements of any relevant Government Agency (including any applicable laws governing the protection and privacy of personal and health information);
(d) conduct Clinical Trials in accordance with the relevant Trial Protocol, consistently with any applicable codes of Good Clinical Practice from time to time;
(e) use appropriate skill, experience, equipment and facilities in the conduct of Clinical Trials;
(f) ensure that all Clinical Trial Materials are handled appropriately and stored securely by MEPL, its employees, contractors and agents for the duration of the Clinical Trials;
(g) use Diligent Efforts ensure that MEPL s employees, contractors and agents who are involved in carrying out Clinical Trials fully understand and adhere to any Trial Protocol; and
(h) take all reasonable measures, in consultation with Novogen Research, to protect Clinical Trial Subjects at risk following any adverse drug experience.
4.4 Clinical Trial Materials
4.5 Records of Clinical Trials
(a) the design of all Trial Protocols and approval of any Government Agency, institutional review board or hospital ethics committee;
(b) all work done and results achieved in the course of Clinical Trials;
(c) details of MEPL s employees, agents and contractors engaged to conduct Clinical Trials, all Clinical Trial Subjects and all other persons involved in Clinical Trials; and
(d) the Clinical Trial Materials.
4.6 Inspection of records
4.7 Reports on Clinical Trials
(a) Within 10 Business Days of a written request by Novogen Research from time to time during the Term, MEPL must submit to Novogen Research a written report on the status of all Clinical Trials.
(b) MEPL must:
(i) notify Novogen Research of any serious adverse drug experience which occurs during the course of Clinical Trials within 1 Business Day of becoming aware of that event; and
(ii) if requested by Novogen Research, assist in reporting that event to any relevant Government Agency, institutional review board or hospital ethics committee.
Publication of results of Clinical Trials
(a) Subject to any obligations MEPL or any related body corporate of MEPL has under any law or rule of any relevant stock exchange, MEPL must not, and must ensure that its employees, agents and contractors do not, publish, present in public or make available to any third party the results of any Clinical Trials without the prior written consent of Novogen Research, which must be provided or declined (with reasons) within 15 Business Days of written request and which must not be withheld unreasonably.
(b) Subject to any obligations Novogen Research or any related body corporate of Novogen Research has under any law or rule of any relevant stock exchange, Novogen Research must not, and must ensure that its employees, agents and contractors do not, publish, present in public or make available to any third party the results of any Clinical Trials without the prior written consent of MEPL, which must be provided or declined (with reasons) within 15 Business Days of written request and which must not be withheld unreasonably.
4.9 Intellectual Property Rights in Clinical Trial Materials
(i) all MEPL Developments; and
(ii) all other developments of, improvements to, enhancements to, adaptations and new applications of Compounds or their use outside the Field made or acquired by MEPL or any MEI Company or their employees, contractors or agents,
5.2 Novogen Developments
6. MARKETING AND COMMERCIALISATION
6.1 Marketing and commercialisation
(a) use Diligent Efforts to Exploit Licensed Products in the Field in the Territory;
(b) conduct, and procure that each of its agents and contractors conduct, any development, scientific, marketing and commercialisation activities with respect to Licensed Products on a commercially reasonable basis and in compliance with any applicable laws and requirements of any Government Agency; and
(c) otherwise act in a manner calculated to maximise the Exploitation of Licensed Products throughout the Territory, to the extent it is commercially reasonable and practicable to do so.
312, Section 312.40 (b) of the Code of Federal Regulations) (or equivalent application with a Government Agency in another country) for a Licensed Product by 31 March 2008;
(b) enrol the first Clinical Trial Subject in a Phase II Clinical Trial by 30 June 2009;
(c) enrol the first Clinical Trial Subject in a Phase III Clinical Trial by 31 December 2011; and
(d) receive a New Drug Application approval (NDA) from the FDA or equivalent approval from a Government Agency in any other country by 31 December 2013.
6.4 Revision of Milestones
(a) If MEPL, acting reasonably, considers that it may be unable to meet a Milestone by the date specified in clause 6.3 it may notify Novogen Research in writing and request a revision of the date for achievement of the Milestone.
(b) Novogen Research must consider any requests from MEPL under paragraph (a) and not unreasonably withhold its consent if the failure to meet the dates arises due to circumstances which were not reasonably foreseeable.
6.5 Continuing obligation
6.6 Records and customer relations
(a) keep for the Term and for a period of 6 years after the end of the Term, accurate and separate records and accounts of the supply of Licensed Products sufficient to enable the recall of Licensed Products by batch number, and must submit copies of those records to Novogen Research immediately upon request by Novogen Research in the event of such a recall;
(b) note details of any customer complaints about Licensed Products and details of any return of Licensed Products and must provide those details to Novogen Research in writing as soon as is practicable after becoming aware of any material complaints affecting the safety or efficacy of the Licensed Products; and
(c) consult with Novogen Research regarding any action to be taken about any customer complaint or return of any Licensed Product.
6.7 Marketing and promotion
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Last updated: May 16, 2006