Delaware | 000-50484 | 51-0407811 | ||
(State or other jurisdiction of | (Commission File Number) | (I.R.S. Employer Identification No.) | ||
incorporation or | ||||
organization) |
o | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
o | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
o | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
o | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 1.01. Entry into a Material Definitive Agreement. | ||||||||
Item 9.01. Financial Statements and Exhibits. | ||||||||
Signature | ||||||||
Index to Exhibits | ||||||||
EX-10.1: AMENDMENT DEED | ||||||||
EX-99.1: PRESS RELEASE |
(c) | Exhibits. |
Exhibit No. | Description | |
10.1
|
Amendment Deed, dated April 3, 2007, by and between Novogen Research Party Limited and Marshall Edwards Pty Limited. | |
99.1
|
Press Release issued by Marshall Edwards, Inc., dated as of April 4, 2007 |
MARSHALL EDWARDS, INC. |
||||
By: | /s/ David R. Seaton | |||
Name: | David R. Seaton | |||
Title: | Chief Financial Officer (Duly Authorized Officer and Principal Financial Officer) |
|||
Exhibit No. | Description | |
10.1
|
Amendment Deed, dated April 3, 2007, by and between Novogen Research Party Limited and Marshall Edwards Pty Limited. | |
99.1
|
Press Release issued by Marshall Edwards, Inc., dated as of April 4, 2007. |
BLAKE DAWSON WALDRON | ||
LAWYERS | ||
Level 36 | |||||||
Grosvenor Place | |||||||
225 George Street | |||||||
Sydney NSW 2000 | |||||||
Telephone: +61 2 9258 6000 | 3rd April 2007 | ||||||
Fax: + 61 2 9258 6999 | Ref: BLM FZD 02 1372 3369 |
1. | INTERPRETATION | 1 | ||||||||
1.1 | Definitions | 1 | ||||||||
1.2 | Terms defined in the Licence Agreement | 1 | ||||||||
1.3 | Rules for interpreting this document | 1 | ||||||||
2. | CONSIDERATION | 2 | ||||||||
3. | AMENDMENT | 2 | ||||||||
4. | REPRESENTATIONS AND WARRANTIES | 2 | ||||||||
4.1 | Representations and warranties | 2 | ||||||||
4.2 | Reliance on representations and warranties | 3 | ||||||||
5. | GENERAL | 3 | ||||||||
5.1 | Governing law | 3 | ||||||||
5.2 | Liability for expenses | 4 | ||||||||
5.3 | Giving effect to this document | 4 | ||||||||
5.4 | Amendment | 4 | ||||||||
5.5 | Counterparts | 4 |
A. | The parties are parties to the Licence Agreement. | |
B. | The parties wish to amend the Licence Agreement on the terms of this document. |
1. | INTERPRETATION | |
1.1 | Definitions | |
The following definitions apply in this document. | ||
Effective Date means the date this document is executed by the last of the parties to execute it. | ||
Licence Agreement means the agreement entitled Amended and Restated Licence Agreement between Novogen Research and MEPL dated 24 September 2003, as further amended by an Amendment Deed between the parties dated 6 June 2006. | ||
1.2 | Terms defined in the Licence Agreement | |
Terms that are not defined in clause 1.1 and that are defined in the Licence Agreement (as amended by this document) have the same meaning in this document. | ||
1.3 | Rules for interpreting this document | |
Headings are for convenience only, and do not affect interpretation. The following rules also apply in interpreting this document, except where the context makes it clear that a rule is not intended to apply. |
(a) | A reference to: |
(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 includes 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. |
2. | CONSIDERATION | |
Each party acknowledges that it has received valuable consideration for entering into this document. | ||
3. | AMENDMENT |
(a) | The Licence Agreement is amended, with effect on the Effective Date, as attached in Annexure A. | ||
(b) | Subject to paragraph (c), paragraph (a) does not affect any right or obligation that arises before the Effective Date. | ||
(c) | The amendments in paragraph (a) are deemed to have taken effect on and from the date the Licence Agreement was executed by the last of the parties to execute it. |
4. | REPRESENTATIONS AND WARRANTIES | |
4.1 | Representations and warranties | |
Each party represents and warrants that: |
(a) | (status) it is a company limited by shares under the Corporations Act; | ||
(b) | (power) it has full legal capacity and power: |
2
(i) | to own its property and assets and to carry on its business; and | ||
(ii) | to enter into this document and to carry out the transactions that it contemplates; |
(c) | (corporate authority) it has taken all corporate action that is necessary or desirable to authorise its entry into this document and its carrying out the transactions that it contemplates; | ||
(d) | (Authorisations) it holds each Authorisation that is necessary or desirable to: |
(i) | execute this document and to carry out the transactions that it contemplates; and | ||
(ii) | ensure that this document is legal, valid, binding and admissible in evidence, |
(e) | (document effective) this document constitutes its legal, valid and binding obligations, enforceable against it in accordance with its terms (except to the extent limited by equitable principles and laws affecting creditors rights generally), subject to any necessary stamping or registration; | ||
(f) | (no contravention) neither its execution of this document, nor the carrying out by it of the transactions that it contemplates, does or will: |
(i) | contravene any law to which it or any of its property is subject or any order of any Government Agency that is binding on it or any of its property; | ||
(ii) | contravene any Authorisation; | ||
(iii) | contravene any undertaking or instrument binding on it or any of its property; or | ||
(iv) | contravene its constitution; and |
(g) | (no trust) it is not entering into this document as trustee of any trust or settlement. |
4.2 | Reliance on representations and warranties | |
Each party acknowledges that the other party has executed this document and agreed to take part in the transactions that it contemplates in reliance on the representations and warranties that are made or repeated in this clause. | ||
5. | GENERAL | |
5.1 | Governing law | |
This document is governed by the law in force in New South Wales. |
3
5.2 | Liability for expenses | |
Each party must pay its own expenses incurred in negotiating, executing, stamping and registering this document. | ||
5.3 | Giving effect to this document | |
Each party must do anything (including execute any document), and must ensure that its employees and agents do anything (including execute any document), that the other party may reasonably require to give full effect to this document. | ||
5.4 | Amendment | |
This document can only be amended, supplemented, replaced or novated by another document signed by the parties. | ||
5.5 | Counterparts | |
This document may be executed in counterparts. |
EXECUTED by NOVOGEN RESEARCH PTY LIMITED: |
||
/s/ Christopher
Naughton |
/s/ Ronald Lea Erratt | |
Signature of director
|
Signature of director/secretary | |
Christopher
Naughton |
Ronald Lea Erratt | |
Name
|
Name | |
EXECUTED by MARSHALL EDWARDS PTY LIMITED: |
||
/s/ Christopher
Naughton |
/s/ David Ross Seaton | |
Signature of director
|
Signature of director/secretary | |
Christopher
Naughton |
David Ross Seaton | |
Name
|
Name |
4
BLAKE DAWSON WALDRON | ||
LAWYERS | ||
Level 41 |
||||
225 George Street |
||||
Sydney NSW 2000 |
||||
Telephone: +61 2 9258 6000
|
24 September 2003 | |||
Fax: +61 2 9258 6999
|
Ref: SJD.BLM.02-1308-9508 | |||
© Blake Dawson Waldron 2002-2003 |
1. | INTERPRETATION | 1 | ||||
1.1 | Definitions | 1 | ||||
1.2 | Rules for interpreting this document | 8 | ||||
1.3 | Business Days | 9 | ||||
2. | LICENCE TO EXPLOIT THE PRODUCT | 9 | ||||
2.1 | Grant of licence | 9 | ||||
2.2 | Exclusivity | 10 | ||||
2.3 | Expiration of Licensed Patent Rights | 10 | ||||
2.4 | Sub-licences | 10 | ||||
2.5 | Sub-contractors | 10 | ||||
3. | CLINICAL TRIALS | 10 | ||||
3.1 | Clinical Trials to date | 10 | ||||
3.2 | Obligation to conduct Clinical Trials | 11 | ||||
3.3 | Conduct of Clinical Trials | 11 | ||||
3.4 | Clinical Trial Materials | 11 | ||||
3.5 | Facilities and personnel | 11 | ||||
3.6 | Records of Clinical Trials | 11 | ||||
3.7 | Inspection of records | 12 | ||||
3.8 | Reports on Clinical Trials | 12 | ||||
3.9 | Publication of results of Clinical Trials | 12 | ||||
3.10 | Intellectual Property Rights in Clinical Trial Materials | 12 | ||||
4. | DEVELOPMENTS | 12 | ||||
4.1 | MEPL Developments | 12 | ||||
4.2 | Novogen Developments | 12 | ||||
5. | MARKETING AND COMMERCIALISATION | 13 | ||||
5.1 | Marketing and commercialisation | 13 | ||||
5.2 | Commercialisation | 13 | ||||
5.3 | Records and customer relations | 13 | ||||
5.4 | Marketing and promotion | 13 | ||||
5.5 | Approval of promotional and advertising material | 14 | ||||
5.6 | Compliance with laws | 14 | ||||
5.7 | Storage and handling | 14 | ||||
5.8 | Compliance with laws | 14 | ||||
5.9 | Packing and transport of Products | 15 | ||||
6. | START GRANT AGREEMENT | 15 | ||||
6.1 | Acknowledgment | 15 |
6.2 | Compliance with the START Grant Agreement | 15 | ||||
6.3 | Compliance with reasonable directions | 15 | ||||
7. | LICENCE FEES | 15 | ||||
7.1 | First lump sum licence fee | 15 | ||||
7.2 | Second lump sum licence fee | 16 | ||||
7.3 | Royalties during the Exclusivity Period | 16 | ||||
7.4 | Royalties after the Exclusivity Period | 16 | ||||
7.5 | Milestone Licence Fees | 16 | ||||
8. | PAYMENT TERMS | 17 | ||||
8.1 | Payments | 17 | ||||
8.2 | Interest on overdue accounts | 17 | ||||
9. | REPORTS AND ACCOUNTING | 17 | ||||
9.1 | Books and records | 17 | ||||
9.2 | Auditors certificates | 17 | ||||
9.3 | Quarterly statements | 17 | ||||
9.4 | Certification | 18 | ||||
9.5 | Adjustments | 18 | ||||
9.6 | Interest on adjustments | 18 | ||||
9.7 | Inspection | 18 | ||||
10. | OTHER COSTS | 19 | ||||
10.1 | Maintenance of Licensed Patent Rights | 19 | ||||
10.2 | Reimbursement by MEPL | 19 | ||||
10.3 | Registration of Products | 19 | ||||
11. | GOODS AND SERVICES TAX | 19 | ||||
11.1 | GST Law definitions | 19 | ||||
11.2 | GST payable in addition to other amounts | 19 | ||||
11.3 | Tax invoice | 20 | ||||
11.4 | Adjustments | 20 | ||||
11.5 | GST where MEPL supplies Novogen Research | 20 | ||||
12. | OTHER DEDUCTIONS AND WITHHOLDINGS | 20 | ||||
13. | INTELLECTUAL PROPERTY RIGHTS | 21 | ||||
13.1 | Acknowledgment | 21 | ||||
13.2 | Maintenance of Licensed Intellectual Property | 21 | ||||
13.3 | Notification | 21 | ||||
13.4 | Proceedings by MEPL | 21 | ||||
13.5 | Directions by Novogen Research | 21 | ||||
13.6 | Joinder of Novogen Research | 22 |
ii.
13.7 | Proceedings by Novogen Research | 22 | ||||
13.8 | Joinder of MEPL | 22 | ||||
13.9 | Damages and settlement amounts | 22 | ||||
13.10 | Assignment of Intellectual Property Rights | 22 | ||||
14. | CONFIDENTIAL INFORMATION | 22 | ||||
14.1 | Confidentiality | 22 | ||||
14.2 | Security | 23 | ||||
14.3 | Exceptions to obligations of confidentiality | 23 | ||||
14.4 | Public domain | 23 | ||||
15. | REPRESENTATIONS AND WARRANTIES | 23 | ||||
15.1 | Warranties of each party | 23 | ||||
15.2 | Representations and warranties by Novogen Research | 24 | ||||
15.3 | Validity of Licensed Patent Rights | 25 | ||||
15.4 | Reliance on representations and warranties | 25 | ||||
16. | LIMITATION OF LIABILITY | 25 | ||||
16.1 | Limitation of liability of Novogen Research | 25 | ||||
16.2 | Liability for infringement of Intellectual Property Rights | 25 | ||||
16.3 | Exclusion of conditions and warranties | 25 | ||||
16.4 | Indirect and consequential loss | 25 | ||||
17. | INDEMNITIES AND INSURANCE | 26 | ||||
17.1 | Clinical Trial indemnity | 26 | ||||
17.2 | Commercialisation indemnity | 26 | ||||
17.3 | MEPLs insurance policies | 27 | ||||
17.4 | Name of Novogen Research | 27 | ||||
17.5 | Certificates of currency | 27 | ||||
17.6 | Default | 27 | ||||
17.7 | Expiry | 27 | ||||
17.8 | Novogen Researchs insurance | 27 | ||||
18. | FORCE MAJEURE | 27 | ||||
18.1 | Notice and suspension of obligations | 27 | ||||
18.2 | Effort to overcome | 28 | ||||
18.3 | Termination | 28 | ||||
19. | TERM AND TERMINATION | 28 | ||||
19.1 | Term | 28 | ||||
19.2 | Termination by Novogen Research | 28 | ||||
19.3 | Termination by MEPL | 29 | ||||
19.4 | Consequences to MEPL of termination | 29 | ||||
19.5 | Consequences to Novogen Research of termination | 29 |
iii.
19.6 | Survival and accrued rights | 30 | ||||
20. | DISPUTE RESOLUTION | 30 | ||||
20.1 | Disputes | 30 | ||||
20.2 | Notice of Dispute | 30 | ||||
20.3 | Negotiation | 30 | ||||
20.4 | Resolution of Dispute | 30 | ||||
20.5 | Mediation | 30 | ||||
21. | NOTICES | 31 | ||||
22. | AMENDMENT AND ASSIGNMENT | 31 | ||||
22.1 | Amendment | 31 | ||||
22.2 | Assignment | 31 | ||||
23. | GENERAL | 31 | ||||
23.1 | Governing law | 31 | ||||
23.2 | Liability for expenses | 32 | ||||
23.3 | Relationship of the parties | 32 | ||||
23.4 | Giving effect to this document | 32 | ||||
23.5 | Waiver of rights | 32 | ||||
23.6 | Operation of this document | 32 | ||||
23.7 | Operation of indemnities | 32 | ||||
23.8 | Consents | 33 | ||||
23.9 | Exclusion of contrary legislation | 33 | ||||
23.10 | Counterparts | 33 | ||||
SCHEDULE 1: Product Patent Rights | 34 | |||||
SCHEDULE 2: Manufacturing Patent Rights | 37 |
iv.
A. | Novogen Research is the proprietor of certain patents, the applicant for certain patent applications and the owner of certain know how relating to: |
(a) | a method of preparation of the compound known as phenoxodiol; and | ||
(b) | agents comprising phenoxodiol and compositions containing it and its use as a human therapeutic treatment. |
B. | MEPL wishes to conduct clinical trials relating to the use of phenoxodiol and to exploit phenoxodiol throughout the world for certain human therapeutic uses. |
C. | In May 2002 Novogen Research agreed to grant to MEPL a licence to conduct clinical trials and to exploit phenoxodiol on terms and conditions set out in a licence agreement between the parties (the Original Licence Agreement). |
D. | The parties have agreed to amend and restate the terms of the Original Licence Agreement as set out in this document with effect from the date of this document. |
1. | INTERPRETATION |
1.1 | Definitions |
(a) | in relation to a body corporate, each of: |
(i) | that bodys related bodies corporate; | ||
(ii) | that bodys directors; and | ||
(iii) | the persons who have a substantial holding (as that term is defined in the Corporations Act) in that body; and |
(b) | in relation to a natural person, any: |
(i) | spouse; |
(ii) | relative by blood or adoption of that person or that persons spouse; and |
(iii) | body corporate in which that person and Affiliates of that person hold in aggregate more than 20% of the voting shares. |
(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, |
(a) | the average, expressed as a yield per cent per annum (rounded up (if necessary) to 4 decimal places) of all rates quoted on each day in the period as the 180 day bank-accepted bill rate on the web site of the Reserve Bank of Australia at www.rba.gov.au (or any web site that replaces that web site); or | ||
(b) | if no rate can be calculated under paragraph (a), the bid rate available to MEPL at about 11.00 am (Sydney time) on that day, as conclusively determined in good faith by MEPL, for Bank Bills that have the tenor described in paragraph (a). |
(a) | Control of the composition of the board of directors of the corporation; | ||
(b) | Control of more than half the voting rights attaching to shares in the corporation; or | ||
(c) | Control of more than half the issued shares of the corporation (not counting any share which carries no right to participate beyond a specified amount in the distribution of either profit or capital), |
(d) | Control of the composition of the board of directors of Novogen Limited; | ||
(e) | Control of more than half the voting rights attaching to shares in Novogen Limited; or |
2.
(f) | Control of more than half the issued shares of Novogen Limited (not counting any share which carries no right to participate beyond a specified amount in the distribution of either profit or capital). |
(a) | in relation to Novogen Research, the Clinical Trial Materials, the Licensed Know How, all Novogen Developments and MEPL Developments, all documents, records and reports relating to the Licensed Intellectual Property or Products, which are provided by MEPL under this document and all other written or oral information disclosed by Novogen Research to MEPL under this document, other than information which MEPL can establish: |
(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 |
(b) | in relation to MEPL, all written or oral information disclosed by MEPL to Novogen Research under this document, other than information referred to in paragraph (a) and information which Novogen Research can establish: |
(i) | was in the public domain when it was given to it; |
3.
(ii) | becomes, after being given to it, part of the public domain, except through disclosure contrary to this document; or | ||
(iii) | was lawfully received by it from another person having the unrestricted legal right to disclose that information without requiring the maintenance of confidentiality. |
(a) | the date of expiration or lapsing of the last Patent Right in the patents and patent applications set out in schedule 1 and 2; or | ||
(b) | the date of expiration or lapsing of the last Licensed Patent Right which MEPL would, but for the licence granted in clause 2.1, infringe in any country in the Territory by doing in that country any of the things set out in clause 2.1. |
4.
(a) | a government or government department or other body; | ||
(b) | a governmental, semi-governmental or judicial person; or | ||
(c) | a person (whether autonomous or not) who is charged with the administration of a law. |
(a) | the same as in the GST Law; and | ||
(b) | any other goods and services tax, or any tax applying to this transaction in a similar way; and | ||
(c) | any additional tax, penalty tax, fine, interest or other charge under a law for such a tax. |
5.
(a) | for the calender year ending 31 December 2003: US$1,000,000; | ||
(b) | for the calender year ending 31 December 2004: US$2,000,000; | ||
(c) | for the calender year ending 31 December 2005: US$4,000,000; and | ||
(d) | upon the receipt by MEPL of the first: |
(i) | approval by the FDA of a New Drug Application (NDA) for a Product (on an accelerated basis or otherwise); | ||
(ii) | approval or authorisation of any kind to market a Product in the United States; or | ||
(iii) | approval or authorisation of any kind by a Government Agency in any other country to market a Product, |
6.
(the Approval Date): US$8,000,000, together with interest on that amount from (and including) 31 December 2006 to (but excluding) the Approval Date, at the Bank Bill Rate; |
(e) | for the calendar year of the year of the Approval Date, and for each calendar year during the Exclusivity Period thereafter: US$8,000,000, |
(a) | trade and quantity discounts; and | ||
(b) | returns, rebates and allowances actually taken. |
7.
1.2 | Rules for interpreting this document |
(a) | A reference to: |
(i) | legislation (including subordinate legislation) is to that legislation as amended, re-enacted or replaced, and includes any subordinate legislation issued under it; | ||
(ii) | a document or agreement, or a provision of a document or agreement, is to that document, agreement or provision as amended, supplemented, replaced or novated; | ||
(iii) | a party to this document or to any other document or agreement includes a permitted substitute or a permitted assign of that party; | ||
(iv) | a person includes any type of entity or body of persons, whether or not it is incorporated or has a separate legal identity, and any executor, administrator or successor in law of the person; and | ||
(v) | anything (including a right, obligation or concept) includes each part of it. |
(b) | A singular word includes the plural, and vice versa. | ||
(c) | A word which suggests one gender includes the other genders. | ||
(d) | If a word is defined, another part of speech has a corresponding meaning. | ||
(e) | If an example is given of anything (including a right, obligation or concept), such as by saying it includes something else, the example does not limit the scope of that thing. |
8.
(f) | The word agreement includes an undertaking or other binding arrangement or understanding, whether or not in writing. | ||
(g) | The words subsidiary, holding company and related body corporate have the same meanings as in the Corporations Act. | ||
(h) | A reference to US$ is to the currency of the United States of America. |
1.3 | Business Days |
(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. |
1.4 | Application of this document |
(a) | This document varies and amends the Original Licence Agreement with effect from the date of execution of this document. | ||
(b) | The terms and conditions of this document replace the terms and conditions of the Original Licence Agreement. |
2. | LICENCE TO EXPLOIT THE PRODUCT |
2.1 | Grant of licence |
(a) | make, have made, sell, hire or otherwise dispose of Products in the Territory for use in the Field; | ||
(b) | offer to make, sell, hire or otherwise dispose of Products in the Territory for use in the Field; | ||
(c) | use and import Products into any country in the Territory for the purpose of exercising its rights under paragraphs (a) and (b); | ||
(d) | use, reproduce, apply, develop, modify and enhance the Licensed Know How in the Field; | ||
(e) | keep Products and the Licensed Know How for the purpose of doing any of the things in paragraphs (a) to (d); and | ||
(f) | use any method or process claimed or disclosed in the Manufacturing Patent Rights or forming part of the Manufacturing Know How for the purpose of exercising its rights under paragraphs (a) to (e). |
9.
2.2 | Exclusivity |
(a) | exclusive in the Field and in the Territory during the Exclusivity Period; and | ||
(b) | non-exclusive in the Field and in the Territory from the date of expiration of the Exclusivity Period until the end of the Term. |
2.3 | Expiration of Licensed Patent Rights |
2.4 | Sub-licences |
(a) | Subject to paragraphs (b) and (c), 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 a sub-licence to Novogen Laboratories on the terms and conditions of the Manufacturing Licence and Supply Agreement. | ||
(c) | Novogen Research must grant its consent to any sub-licence proposed to be granted by MEPL in the circumstances set out in clause 3.9 of the Manufacturing Licence and Supply Agreement provided that sub-licence is in terms substantially consistent with those in the Manufacturing Licence and Supply Agreement. |
2.5 | Sub-contractors |
(a) | without the prior written consent of Novogen Research; and | ||
(b) | 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 Novogen Research all Intellectual Property Rights in the Field created or acquired by them in the course of their engagement. |
3. | CLINICAL TRIALS | |
3.1 | Clinical Trials to date |
(a) | Novogen Limited has sponsored and funded phase 1 Clinical Trials in Australia; |
10.
(b) | Novogen Limited has obtained the FDA Approval; and | ||
(c) | the FDA Approval has not been revoked or amended. |
3.2 | Obligation to conduct Clinical Trials |
3.3 | Conduct of Clinical Trials |
(a) | fund or arrange adequate third party funding of Clinical Trials; | ||
(b) | use all reasonable endeavours to design and conduct Clinical Trials to generate outcomes which are calculated to result in regulatory approval of a Product for use in the Field; | ||
(c) | conduct Clinical Trials diligently, in good scientific manner, in compliance with any applicable laws, rules and regulations of any Government Agency in the Territory (including any laws governing the protection and privacy of personal information), in accordance with any Trial Protocol and any other reasonable directions given by Novogen Research from time to time, and consistently with the requirements of any applicable good laboratory practices; | ||
(d) | 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; | ||
(e) | ensure that MEPLs employees, contractors, sub-licensees and agents who are involved in carrying out Clinical Trials fully understand and adhere to any Trial Protocol; and | ||
(f) | take all reasonable measures, in consultation with Novogen Research, to protect Clinical Trial Subjects at risk following a serious adverse drug experience. |
3.4 | Clinical Trial Materials | |
MEPL shall be solely responsible for providing all Clinical Trial Materials necessary for the conduct of Clinical Trials. |
3.5 | Facilities and personnel | |
In order to comply with its obligations under this clause 3, MEPL must, and must ensure that its employees, agents, contractors and sub-licensees use appropriate skill, experience, equipment and facilities. |
3.6 | Records of Clinical Trials |
11.
(a) | all work done and results achieved in the course of Clinical Trials; | ||
(b) | details of MEPLs employees, agents, contractors and sub-licensees engaged to conduct Clinical Trials, all Clinical Trial Subjects and all other persons involved in Clinical Trials; and | ||
(c) | the Clinical Trial Materials. |
3.7 | Inspection of records |
3.8 | Reports on Clinical Trials |
(a) | Within 5 Business Days of a written request by Novogen Research from time to time during the Term, MEPL shall submit a written report to Novogen Research on the status of all Clinical Trials. | ||
(b) | MEPL shall immediately report to Novogen Research any serious adverse drug experience which occurs during the course of Clinical Trials, and if requested by Novogen Research, MEPL shall cooperate in reporting that experience to any relevant third party or Government Agency. |
3.9 | Publication of results of Clinical Trials |
3.10 | Intellectual Property Rights in Clinical Trial Materials |
4. | DEVELOPMENTS | |
4.1 | MEPL Developments |
4.2 | Novogen Developments |
12.
5. | MARKETING AND COMMERCIALISATION |
5.1 | Marketing and commercialisation |
5.2 | Commercialisation |
(a) | conduct any marketing and commercialisation activities on a commercially reasonable basis, in compliance with any applicable laws, rules and regulations of any Government Agency; | ||
(b) | observe all reasonable directions and instructions given to it by Novogen Research about marketing and commercialisation of any Product, including directions about the preparation of or amendment of any advertising, publicity, sales literature or other document relating to the Product; and | ||
(c) | otherwise act as it reasonably considers to be most beneficial to the interests of MEPL and Novogen Research. |
5.3 | Records and customer relations |
(a) | keep accurate and separate records and accounts of the supply of Products sufficient to enable the recall of Products by batch number, and must submit copies of those records to Novogen Research immediately upon request by Novogen Research; | ||
(b) | note details of any customer complaints about Products and details of any return of any Product and must provide those details to Novogen Research in writing as soon as is practicable after becoming aware of them; | ||
(c) | provide all reasonable assistance to Novogen Research if Novogen Research wishes to investigate any customer complaint or return of any Product; and | ||
(d) | consult with Novogen Research regarding any action to be taken about any customer complaint or return of any Product. |
5.4 | Marketing and promotion |
(a) | act in good faith towards Novogen Research and actively promote sales of Products and develop markets for Products throughout the Territory; | ||
(b) | not during the Term do anything which might injure or destroy the market in the Territory for Products; |
13.
(c) | subject to applicable laws and regulations in the Territory, advertise Products to keep customers and potential customers informed of them; | ||
(d) | subject to applicable laws and regulations in the Territory, disseminate samples of Products and technical and promotional literature about Products; and | ||
(e) | subject to applicable laws and regulations in the Territory, establish advertising or promotional programs for Products. |
5.5 | Approval of promotional and advertising material |
(a) | submit to Novogen Research for prior approval by Novogen Research representative samples of any promotional piece, advertising or technical narrative in relation to Products; | ||
(b) | use promotional pieces, advertising and technical narratives only in accordance with the prior written consent of Novogen Research and any conditions attaching to that consent; and | ||
(c) | make no representation or warranty about Products except with the prior written consent of Novogen Research. |
5.6 | Compliance with laws |
5.7 | Storage and handling |
(a) | store Products safely and securely and in accordance with the reasonable written directions of Novogen Research from time to time; and | ||
(b) | permit Novogen Research to inspect Products in the possession, custody or control of MEPL, its agents, contractors and sub-licensees. |
5.8 | Compliance with laws |
14.
5.9 | Packing and transport of Products |
6. | START GRANT AGREEMENT |
6.1 | Acknowledgment |
(a) | Novogen Limited has obligations to the Commonwealth under the START Grant Agreement with respect to the conduct of Clinical Trials and the commercialisation of Products; and | ||
(b) | Novogen Limited has undertaken (or proposes to undertake) to the Commonwealth under the Deed of Acknowledgment and Undertaking to procure that certain of its obligations under the START Grant Agreement are fulfilled by its subsidiaries, including MEPL. |
6.2 | Compliance with the START Grant Agreement |
(a) | exercise MEPLs rights or perform MEPLs obligations in a manner which is inconsistent with the obligations of Novogen Limited under the START Grant Agreement; or | ||
(b) | otherwise do anything which may cause Novogen Limited to be in default of its obligations under the START Grant Agreement or the Deed of Acknowledgment and Undertaking. |
6.3 | Compliance with reasonable directions |
7. | LICENCE FEES |
7.1 | First lump sum licence fee |
(a) | 1 November 2002; or | ||
(b) | the date on which the cumulative total of any: |
15.
(i) | funding (whether debt or equity); | ||
(ii) | Commercialisation Income; and | ||
(iii) | income as a result of or in connection with the sale, hiring or other disposal of Products, |
7.2 | Second lump sum licence fee |
(a) | 1 November 2003; or | ||
(b) | the date on which the cumulative total of any: |
(i) | funding (whether debt or equity); | ||
(ii) | Commercialisation Income; and | ||
(iii) | income as a result of or in connection with the sale, hiring or other disposal of Products, |
7.3 | Royalties during the Exclusivity Period |
(a) | 2.5% of all Net Sales of Products in the Territory, Quarterly in arrears, within 30 days of the end of each Quarter; and | ||
(b) | 25% of all Commercialisation Income, Quarterly in arrears within 30 days of the end of each Quarter. |
7.4 | Royalties after the Exclusivity Period |
7.5 | Milestone Licence Fees |
16.
(a) | each Milestone Licence Fee payable for a calendar year within 30 days following the end of the relevant calendar year; and | ||
(b) | the Milestone Licence Fee payable on the Approval Date within 30 days following the Approval Date. |
8. | PAYMENT TERMS |
8.1 | Payments |
8.2 | Interest on overdue accounts |
9. | REPORTS AND ACCOUNTING |
9.1 | Books and records |
(a) | all marketing, sale, distribution, exploitation and commercialisation of Products; and | ||
(b) | any assignment, sublicensing, or other dealing with MEPLs rights under this document, |
9.2 | Auditors certificates |
9.3 | Quarterly statements |
(a) | the progress of marketing and commercialisation of Products; |
17.
(b) | details of any Commercialisation Income received by or on behalf of MEPL and its subsidiaries in the period to which the statement relates; | ||
(c) | details of any funding received by or on behalf of MEPL and its subsidiaries, by way of debt, equity or otherwise; | ||
(d) | details of all income received by or on behalf of MEPL and its subsidiaries as a result of or in connection with the sale, hiring or other disposal of Product; and | ||
(e) | the calculation of any payments due under clause 7; |
9.4 | Certification |
9.5 | Adjustments |
(a) | A certification of a statement under clause 9.4 is final and binding on the parties. | ||
(b) | Within 14 days of notice in writing by Novogen Research of the certification under clause 9.4, the parties must make any adjustments required as a result of the certification, including: |
(i) | any refund by Novogen Research to MEPL of the amount of any overpayment; and | ||
(ii) | any payment by MEPL to Novogen Research of the amount of any underpayment. |
(c) | If the certification reveals the amount paid to Novogen Research was underestimated by 5% or more, then within 14 days of notice of the certification, MEPL must also reimburse Novogen Research the cost of certification. |
9.6 | Interest on adjustments |
9.7 | Inspection |
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10. | OTHER COSTS |
10.1 | Maintenance of Licensed Patent Rights |
10.2 | Reimbursement by MEPL |
10.3 | Registration of Products |
(a) | register and maintain the registration of Products for use in the Field in accordance with any applicable laws, rules and regulations of any Government Agency; and | ||
(b) | do everything necessary to apply for and obtain each Authorisation from a Government Agency required by any applicable law in the Territory for the importation, promotion, distribution, storage, sale and use of Products in the Field. |
11. | GOODS AND SERVICES TAX |
11.1 | GST Law definitions |
11.2 | GST payable in addition to other amounts |
(a) | pay to Novogen Research an amount equal to any GST payable on any supply by Novogen Research under or in connection with this document without deduction or set-off of any other amount; | ||
(b) | make that payment: |
(i) | if Novogen Research must pay GST on or after receiving the consideration or any part of it as and when MEPL must pay or provide the consideration or that part of it; |
19.
(ii) | if Novogen Research must pay GST on issuing an invoice under this document on the earlier of the due date for payment of that invoice, or 10 Business Days following the end of the month in which Novogen Research issued that invoice; and | ||
(iii) | if Novogen Research must pay GST upon the occurrence of some other event within 5 Business Days of a written request by Novogen Research for payment for the GST, which may be in the form of a tax invoice (or an adjustment note); and |
(c) | indemnify Novogen Research against, and pay Novogen Research on demand the amount of: |
(i) | all GST on the transactions contemplated by this document; and | ||
(ii) | any loss, liability or expense directly or indirectly incurred in connection with or arising from or caused by any failure by MEPL to pay any amount as and when required by this clause 11, for example, any additional tax, penalty tax, fine, interest or other charge under a GST Law. |
11.3 | Tax invoice |
11.4 | Adjustments |
11.5 | GST where MEPL supplies Novogen Research |
12. | OTHER DEDUCTIONS AND WITHHOLDINGS |
(a) | notify Novogen Research of the obligation promptly after MEPL becomes aware of it; |
20.
(b) | ensure that the deduction or withholding does not exceed the minimum amount required by law; | ||
(c) | pay to the relevant Government Agency on time the full amount of the deduction or withholding and promptly deliver to Novogen Research a copy of any receipt, certificate or other proof of payment; and | ||
(d) | indemnify Novogen Research against the deduction or withholding, by paying to Novogen Research, at the time that the payment is due, an additional amount that ensures that, after the deduction or withholding is made, Novogen Research receives a net sum equal to the sum that it would have received if the deduction or withholding had not been made. |
13. | INTELLECTUAL PROPERTY RIGHTS |
13.1 | Acknowledgment |
13.2 | Maintenance of Licensed Intellectual Property |
13.3 | Notification |
(a) | any actual or apparent infringement by any person of the Licensed Intellectual Property; or | ||
(b) | any assertion or claim by any person that the activities of a party under this document infringe the Intellectual Property Rights of any person. |
13.4 | Proceedings by MEPL |
13.5 | Directions by Novogen Research |
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13.6 | Joinder of Novogen Research |
13.7 | Proceedings by Novogen Research |
13.8 | Joinder of MEPL |
13.9 | Damages and settlement amounts |
13.10 | Assignment of Intellectual Property Rights |
14. | CONFIDENTIAL INFORMATION |
14.1 | Confidentiality |
(a) | keep and maintain all Confidential Information of the other party strictly confidential; | ||
(b) | use Confidential Information of the other parties only for the purposes for which it is disclosed; and |
22.
(c) | not disclose any Confidential Information of another party other than to its employees, authorised sub-contractors, legal advisers, auditors or other consultants requiring the information for the purposes of this document and then only upon those persons undertaking in writing to keep that information strictly confidential. |
14.2 | Security |
14.3 | Exceptions to obligations of confidentiality |
14.4 | Public domain |
15. | REPRESENTATIONS AND WARRANTIES |
15.1 | Warranties of each party |
(a) | (status) it is a company limited by shares under the Corporations Act; | ||
(b) | (power) it has full legal capacity and power to: |
(i) | own its property and to carry on its business; and | ||
(ii) | enter into this document and to carry out the transactions that this document contemplates; |
(c) | (corporate authority) it has taken all corporate action that is necessary or desirable to authorise its entry into this document and its carrying out the transactions that this document contemplates; | ||
(d) | (Authorisations) it holds each Authorisation that is necessary or desirable to: |
(i) | enable it to properly execute this document and to carry out the transactions that this document contemplates; | ||
(ii) | ensure that this document is legal, valid, binding and admissible in evidence; or |
23.
(iii) | enable it to properly carry on its business, |
(e) | (documents effective) this document constitutes its legal, valid and binding obligations, enforceable against it in accordance with its terms (except to the extent limited by equitable principles and laws affecting creditors rights generally), subject to any necessary stamping or registration; | ||
(f) | (no contravention) neither its execution of this document nor the carrying out by it of the transactions that this document contemplates, does or will: |
(i) | contravene any law to which it or any of its property is subject or any order of any Government Agency that is binding on it or any of its property; | ||
(ii) | contravene any Authorisation; | ||
(iii) | contravene any undertaking or instrument binding on it or any of its property; | ||
(iv) | contravene its constitution; or | ||
(v) | require it to make any payment or delivery in respect of any financial indebtedness before it would otherwise be obliged to do so. |
15.2 | Representations and warranties by Novogen Research |
(a) | (ownership) to the best of its knowledge Novogen Research is the legal and beneficial owner of the Licensed Intellectual Property and to the best of its knowledge no other person has or shall have any claim of ownership with respect to the Licensed Intellectual Property; | ||
(b) | (no dealings) subject to the START Grant Agreement, it has not assigned or granted to any person any right, title or interest in or in relation to the Licensed Intellectual Property; | ||
(c) | (no Encumbrance) subject to the Fixed and Floating Charge, the Licensed Intellectual Property is free from any Encumbrance; | ||
(d) | (filing, prosecution and maintenance) Novogen Research has diligently filed, prosecuted and maintained the patents and patent applications listed in schedule 1 and as at the Commencement Date all filing, prosecution and maintenance fees have been paid; | ||
(e) | (confidentiality) to its knowledge Novogen Research has kept the Licensed Know How confidential and to its knowledge there has been no breach of that confidentiality; |
24.
(f) | (no infringement) to its knowledge the exercise by MEPL, in any country in which a patent application in schedule 1 has been filed, of the rights granted to MEPL under this document with respect to the Licensed Intellectual Property does not infringe the Intellectual Property Rights of any person; and | ||
(g) | (no further Patent Rights) other than the Licensed Patent Rights, Novogen Research has no Patent Rights which are necessary in order for MEPL to exercise its rights and perform its obligations under this document. |
15.3 | Validity of Licensed Patent Rights | |
MEPL acknowledges that Novogen Research makes and has made no representation, warranty, statement or promise to the effect that: |
(a) | any letters patent will be granted in respect of the Licensed Intellectual Property in any country in the Territory; or | ||
(b) | if any letters patent are granted in respect of the Licensed Intellectual Property in any country in the Territory, such letters patent will be valid. |
15.4 | Reliance on representations and warranties | |
Each party acknowledges that the other party has executed this document and agreed to take part in the transactions that this document contemplates in reliance on the representations and warranties that are made in this document. |
16. | LIMITATION OF LIABILITY | |
16.1 | Limitation of liability of Novogen Research | |
Subject to clause 16.2 and to the extent permitted by law, the liability of Novogen Research to MEPL under this document and any other liability of Novogen Research to MEPL, whether in contract, tort (including negligence and breach of statutory duty) or otherwise is limited to US$200,000. | ||
16.2 | Liability for infringement of Intellectual Property Rights | |
Clause 16.1 does not apply to any liability which Novogen Research may have to MEPL with respect to any breach by Novogen Research of the representations and warranties in clauses 15.2(a), (b), (c) and (f). | ||
16.3 | Exclusion of conditions and warranties | |
Except for the warranties expressly made in this document, all conditions, warranties, undertakings or representations express or implied arising by statute, general law or otherwise are expressly excluded to the extent permitted by law. | ||
16.4 | Indirect and consequential loss | |
Notwithstanding any other provision of this document, and to the extent permitted by law, in no circumstances is Novogen Research liable in contract, tort (including negligence or breach of statutory duty) or otherwise, and whatever the cause, to compensate MEPL for: |
25.
(a) | any increased costs or expenses; | ||
(b) | any economic loss, loss of profit, revenue, business, contracts or anticipated savings; or | ||
(c) | any other special, indirect or consequential loss or damage of any nature. |
17. | INDEMNITIES AND INSURANCE | |
17.1 | Clinical Trial indemnity | |
MEPL must indemnify and keep indemnified Novogen Research, its directors, employees and agents against all damages, costs or expenses (including legal costs and expenses on an indemnity basis) in respect of any claims, demands, actions, proceedings or prosecution which may be brought or commenced as a result of or in relation to: |
(a) | the conduct of Clinical Trials generally; or | ||
(b) | any personal injury to or death of a Clinical Trial Subject arising out of or relating to the administration of the Products or any clinical intervention or procedure provided for or required for the purposes of the Clinical Trials to which the Clinical Trial Subjects would not have been exposed but for their participation in the Clinical Trials, |
17.2 | Commercialisation indemnity | |
MEPL must indemnify and keep indemnified Novogen Research, its directors, employees and agents against all damages, costs or expenses (including legal costs and expenses on an indemnity basis) in respect of any claims, demands, actions, proceedings or prosecution which may be brought or commenced as a result of or in relation to: |
(a) | the licensing or sub-licensing of the Licensed Intellectual Property; | ||
(b) | the sale, distribution or other commercialisation or exploitation of Products; or | ||
(c) | any packaging, marketing, advertisement or promotion of Products, |
26.
17.3 | MEPLs insurance policies | |
MEPL must take out and maintain in force in the Territory comprehensive general liability insurance including advertising and product liability insurance for personal injury and property damage and product recall insurance, in relation to all Products on terms satisfactory to Novogen Research. | ||
17.4 | Name of Novogen Research | |
If requested by Novogen Research, MEPL must ensure that that Novogen Research is included on the policies referred to in clause 17.3 as a joint insured or loss payee. | ||
17.5 | Certificates of currency | |
At the request of Novogen Research from time to time, MEPL must provide to Novogen Research a certificate of currency evidencing its compliance with its obligations under this clause 17. | ||
17.6 | Default | |
If within 15 Business Days of a request by Novogen Research under clause 17.5, MEPL does not comply with its obligations under that clause, Novogen Research may (but is not obliged to) take out and maintain the insurance and may recover any premiums paid as a debt due by MEPL. | ||
17.7 | Expiry | |
MEPL shall maintain each insurance policy referred to in clause 17.3 until the expiry date of the last Product sold, hired or otherwise disposed of by or on behalf of MEPL or its sub-licensees. | ||
17.8 | Novogen Researchs insurance | |
Novogen Research must take out and maintain in force in the Territory comprehensive general liability insurance policies in relation to its obligations under this document on terms reasonably satisfactory to MEPL. | ||
18. | FORCE MAJEURE | |
18.1 | Notice and suspension of obligations | |
If a party to this document is affected, or likely to be affected, by a Force Majeure Event: |
(a) | that party must immediately give the other prompt notice of that fact including: |
(i) | full particulars of the Force Majeure Event; | ||
(ii) | an estimate of its likely duration; | ||
(iii) | the obligations affected by it and the extent of its effect on those obligations; and |
27.
(iv) | the steps taken to rectify it; and |
(b) | the obligations under this document of the party giving the notice are suspended to the extent to which they are affected by the relevant Force Majeure Event as long as the Force Majeure Event continues. |
18.2 | Effort to overcome | |
A party claiming a Force Majeure Event must use its best endeavours to remove, overcome or minimise the effects of that Force Majeure Event as quickly as possible. However, this does not require a party to settle any industrial dispute in any way it does not want to. | ||
18.3 | Termination | |
If a Force Majeure Event continues for more than 3 months, any party may terminate this document by giving at least 10 Business Days notice to the other parties. | ||
19. | TERM AND TERMINATION | |
19.1 | Term |
(a) | Subject to paragraph (b), the rights and obligations of the parties under this document begin on the Commencement Date and continue until this document is terminated in accordance with this clause 19. | ||
(b) | The variations made by this document to the Original Licence Agreement are effective from the date of this document. |
19.2 | Termination by Novogen Research | |
Novogen Research may terminate this document at any time: |
(a) | immediately if MEPL defaults in the performance of any of its obligations under this document which in Novogen Researchs reasonable opinion is capable of remedy and fails to remedy that default within 21 days of receiving written notice from Novogen Research specifying the default and requiring the default to be remedied; | ||
(b) | on 21 days written notice if MEPL defaults in the performance of any of its material obligations under this document which in Novogen Researchs reasonable opinion is not capable of remedy; and | ||
(c) | immediately by notice in writing if: |
(i) | there is a Change of Control of MEPL without Novogen Researchs written consent (which shall not be unreasonably withheld or delayed or conditioned); | ||
(ii) | MEPL is involved in an Insolvency Event; or |
28.
(iii) | MEPL ceases for any reason to be able lawfully to carry out all the transactions which this document contemplates may be carried out by MEPL. |
19.3 | Termination by MEPL | |
MEPL may terminate this document at any time: |
(a) | on three months written notice to Novogen Research; | ||
(b) | immediately if Novogen Research defaults in the performance of any of its obligations under this document which in MEPLs reasonable opinion is capable of remedy and fails to remedy that default within 21 days of receiving written notice from MEPL specifying the default and requiring the default to be remedied; | ||
(c) | on 21 days written notice if Novogen Research defaults in the performance of any of its material obligations under this document which in MEPLs reasonable opinion is not capable of remedy; and | ||
(d) | immediately by notice in writing if: |
(i) | Novogen Research is involved in an Insolvency Event; or | ||
(ii) | Novogen Research ceases for any reason to be able lawfully to carry out all the transactions which this document contemplates may be carried out by Novogen Research. |
19.4 | Consequences to MEPL of termination | |
Upon termination of this document MEPL must: |
(a) | immediately cease using and exploiting the Products; | ||
(b) | within 14 Business Days return to Novogen Research or destroy at Novogen Researchs election, all Products, Clinical Trial Materials, all copies (including electronic copies) of any labelling and packaging materials relating to Products and any other Confidential Information of Novogen Research in MEPLs possession, custody or power; and | ||
(c) | cooperate with Novogen Research and do everything necessary to bring about the orderly and medically and ethically permissible termination of all Clinical Trials, | ||
provided that MEPL may complete in accordance with its obligations under this document any contracts for sale or supply of Products to which MEPL is bound prior to the date of termination. |
19.5 | Consequences to Novogen Research of termination | |
Upon termination of this document Novogen Research must return to MEPL or destroy at MEPLs election within 10 Business Days, all Confidential Information of MEPL in the possession, custody or power of Novogen Research. |
29.
19.6 | Survival and accrued rights | |
Upon termination under this clause 19, this document is at an end as to its future operation except for: |
(a) | the enforcement of any right or claim which arises on or has arisen before termination; and | ||
(b) | the obligations of the parties under clauses 1, 3.6, 3.7, 3.9, 5.3, 9, 13.1, 13.9, 14, 16, 17, 20, 21 and 23 (except clause 23.4) and this clause 19 which survive termination. |
20. | DISPUTE RESOLUTION | |
20.1 | Disputes | |
If a dispute arises out of or in relation to this document (including any dispute as to breach or termination of the document or as to any claim in tort, in equity or pursuant to any statute) (a Dispute), a party to this document may not commence any court or arbitration proceedings relating to the Dispute unless it has complied with this clause 20 except where the party seeks urgent interlocutory relief. | ||
20.2 | Notice of Dispute | |
A party to this document claiming that a Dispute has arisen under or in relation to this document must give written notice to the other party specifying the nature of the Dispute (a Dispute Notice). | ||
20.3 | Negotiation | |
Upon receipt by a party of a Dispute Notice, Novogen Research and MEPL must procure that their respective Managing Directors meet to endeavour to resolve the Dispute expeditiously by negotiation. | ||
20.4 | Resolution of Dispute | |
If the parties have not resolved the Dispute under clause 20.3 within 14 days of receipt of a Dispute Notice, the parties must endeavour to resolve the Dispute expeditiously using informal dispute resolution techniques such as mediation, expert evaluation or determination or similar techniques agreed by the parties. | ||
20.5 | Mediation | |
If the parties do not agree within 28 days of receipt of a Dispute Notice (or such further period as the parties agree in writing) as to: |
(a) | the dispute resolution technique and procedures to be adopted; | ||
(b) | the timetable for all steps in those procedures; and | ||
(c) | the selection and compensation of the independent person required for such technique, |
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the parties must mediate the Dispute in accordance with the Mediation Rules of the Law Society of New South Wales. |
21. | NOTICES |
(a) | A notice, consent or other communication under this document is only effective if it is in writing, signed and either left at the addressees address or sent to the addressee by mail or fax. If it is sent by mail, it is taken to have been received 3 working days after it is posted. If it is sent by fax, it is taken to have been received when the addressee actually receives it in full and in legible form. | ||
(b) | The parties addresses and fax numbers are those set out below, or as a party notifies the other: |
Novogen Research
|
|||
Address:
|
140 Wicks Road, North Ryde NSW 2113 AUSTRALIA | ||
Fax number:
|
Int + 612 9878 0055 | ||
Attention:
|
Managing Director | ||
MEPL
|
|||
Address:
|
140 Wicks Road, North Ryde NSW 2113 AUSTRALIA | ||
Fax number:
|
Int + 612 9878 0055 | ||
Attention:
|
Managing Director |
22. | AMENDMENT AND ASSIGNMENT | |
22.1 | Amendment | |
This document can only be amended, supplemented, replaced or novated by another document signed by the parties. | ||
22.2 | Assignment |
(a) | MEPL may only dispose of, declare a trust over or otherwise create an interest in its rights under this document with the prior written consent of Novogen Research. | ||
(b) | Novogen Research may dispose of, declare a trust over or otherwise create an interest in its rights under this document without the consent of MEPL, and may disclose to any potential holder of the right or interest any information relating to this document or any party to it. |
23. | GENERAL | |
23.1 | Governing law |
(a) | This document is governed by the law in force in New South Wales. | ||
(b) | Each party submits to the non-exclusive jurisdiction of the courts exercising jurisdiction in New South Wales, and any court that may hear appeals from any of those courts, for any proceedings in connection with this document, and waives any right it might have to claim that those courts are an inconvenient forum. |
31.
23.2 | Liability for expenses | |
Each party must pay its own expenses incurred in negotiating, executing, stamping and registering this document. | ||
23.3 | Relationship of the parties | |
Nothing in this document creates a relationship of employment, partnership or joint venture between the parties under the laws of any applicable jurisdiction and no party may act or has the authority to act as agent of or in any way bind or commit another party to any obligation. | ||
23.4 | Giving effect to this document | |
Each party must do anything (including execute any document), and must ensure that its employees and agents do anything (including execute any document), that the other party may reasonably require to give full effect to this document. | ||
23.5 | Waiver of rights | |
A right may only be waived in writing, signed by the party giving the waiver, and: |
(a) | no other conduct of a party (including a failure to exercise, or delay in exercising, the right) operates as a waiver of the right or otherwise prevents the exercise of the right; | ||
(b) | a waiver of a right on one or more occasions does not operate as a waiver of that right if it arises again; and | ||
(c) | the exercise of a right does not prevent any further exercise of that right or of any other right. |
23.6 | Operation of this document |
(a) | This document contains the entire document between the parties about its subject matter. Any previous understanding, document, representation or warranty relating to that subject matter is replaced by this document and has no further effect. | ||
(b) | Any right that a person may have under this document is in addition to, and does not replace or limit, any other right that the person may have. | ||
(c) | Any provision of this document which is unenforceable or partly unenforceable is, where possible, to be severed to the extent necessary to make this document enforceable, unless this would materially change the intended effect of this document. |
23.7 | Operation of indemnities |
(a) | Each indemnity in this document survives the expiry or termination of this document. |
32.
(b) | A party may recover a payment under an indemnity in this document before it makes the payment. |
23.8 | Consents | |
Where this document contemplates that a party may agree or consent to something (however it is described), that party may: |
(a) | agree or consent, or not agree or consent, in its absolute discretion; and | ||
(b) | agree or consent subject to conditions, | ||
unless this document expressly contemplates otherwise. |
23.9 | Exclusion of contrary legislation | |
Any legislation that adversely affects an obligation of a party, or the exercise by a party of a right or remedy, under or relating to this document is excluded to the full extent permitted by law. | ||
23.10 | Counterparts | |
This document may be executed in counterparts. |
EXECUTED as an agreement. |
||
EXECUTED by NOVOGEN RESEARCH PTY LIMITED |
||
Signature of director
|
Signature of director/secretary | |
Name of director
|
Name of director/secretary | |
EXECUTED by MARSHALL EDWARDS PTY LIMITED |
||
Signature of director
|
Signature of director/secretary | |
Name of director
|
Name of director/secretary |
33.
Application/patent | No. | Status | ||
Australia |
731951 | Granted | ||
Australia |
19723/01 | Under examination | ||
Australia |
750031 | Granted | ||
Australia |
PP1124 | Completed | ||
provisional patent | ||||
application | ||||
Australia |
PO2039 | Completed | ||
provisional patent | ||||
application | ||||
Australia |
PS1594 | Completed | ||
provisional patent | ||||
application | ||||
Australia |
2002950294 | Completed | ||
provisional patent | ||||
application | ||||
Australia |
2002951607 | Completed | ||
provisional patent | ||||
application | ||||
Australia |
2002953453 | Completed | ||
provisional patent | ||||
application | ||||
Brazil |
9713180-6 | Under examination | ||
Brazil |
9814343-3 | Under examination | ||
Canada |
2,265,049 | Under examination | ||
Canada |
2316349 | Pending | ||
Czech Republic |
PV 699-99 | Under examination | ||
Europe |
97937345.3 | Pending | ||
Europe |
98960911.0 | Pending | ||
Hong Kong |
1019553 | Granted | ||
Hungary |
P9903971 | Under examination | ||
Israel |
128765 | Under examination |
34.
Application/patent | No. | Status | ||
Israel |
136784 | Pending | ||
Japan |
10-511105 | Under examination | ||
Mexico |
992092 | Pending | ||
Mexico |
006311 | Pending | ||
New Zealand |
334025 | Granted | ||
New Zealand |
506063 | Under examination | ||
New Zealand |
505377 | Accepted | ||
Norway |
19990965 | Pending | ||
Norway |
20003201 | Pending | ||
Peoples Republic
of China |
97198690.8 | Under examination | ||
Portugal |
98/08503 | Pending | ||
Singapore |
64139 | Granted | ||
Singapore |
74235 | Granted | ||
Sweden |
2286-3 | Under examination | ||
Turkey |
TR19990885B | Granted | ||
Turkey |
2000/2064 | Pending | ||
United Kingdom |
2331015 | Granted | ||
United States of
America |
09/254026 | Under examination | ||
United States of |
Serial number not allocated | |||
America |
Continuation of 09/254026 | Filed 6 August 2003 | ||
United States of
America |
10/212847 | Under examination | ||
United States of
America |
10/176762 | Under examination | ||
United States of
America |
6455032 | Granted | ||
Zimbabwe |
12/99 | Accepted | ||
International |
PCT/AU03/00427 | Pending | ||
International |
PCT/AU97/00563 | National phase | ||
entry completed |
35.
Application/patent | No. | Status | ||
International |
PCT/AU98/01054 | National phase | ||
entry completed |
36.
Application | No. | Status | ||
Australia |
26510/00 | Under examination | ||
Australia |
PP8685 | Completed provisional | ||
patent application | ||||
Brazil |
0008222-8 | Pending | ||
Canada |
2362819 | Pending | ||
China |
00803816.3 | Under examination | ||
Czech Republic |
PV 2001-2920 | Pending | ||
Europe |
00904727.5 | Under examination | ||
Hong Kong |
02103732.5 | Pending | ||
Hungary |
PO105218 | Pending | ||
Israel |
144008 | Pending | ||
Japan |
2000-599749 | Pending | ||
Mexico |
008233 | Pending | ||
New Zealand |
512696 | Lapsed | ||
New Zealand |
527700 (divisional) | Pending | ||
Norway |
20013945 | Pending | ||
Singapore |
200103867-8 | Pending | ||
South Africa |
20016502 | Pending | ||
Turkey |
01/2367 | Under examination | ||
United States of America |
09/889701 | Under examination | ||
International |
PCT/AU00/00103 | National phase entry | ||
completed |
37.
CONTACT: | David Sheon 202 518-6384 (USA) Mr Christopher Naughton (CEO, Marshall Edwards, Inc) +612 8878 6196 (Australia) |