Subject matter |
Biological Resources and Traditional Knowledge
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Summary of use(s) |
Under Australian legislation benefit-sharing agreements must provide for reasonable benefit-sharing arrangements with Indigenous people's, including the protection for and valuing of any Indigenous peoples' knowledge. Prior informed consent of the Indigenous owner or native title holder must be obtained for access is to genetic resources on Indigenous people's land. A general principle accepted by all Australian Governments is that access and benefit-sharing must ensure the use of traditional knowledge is undertaken with the cooperation and approval of the holders of that knowledge and on mutually agreed terms.
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Purpose or background |
The objective of the model access and benefit sharing contract (the Deed) is to allow the Commonwealth of Australia or other access providers to manage their biological resources to ensure fair and equitable sharing of the benefits arising from the use of genetic resources in accordance with domestic legislation. Section 301 of the Environment Protection and Biodiversity Conservation Act 1999 (EPBC Act) provides for regulations to be made for the control of access to biological resources in Commonwealth areas of Australia, including the equitable sharing of benefits arising from the use of the biological resources in Commonwealth areas. Part 8A of the Environment Protection and Biodiversity Conservation Regulations 2000 (EPBC Regulations) require an applicant for a permit to access biological resources for commercial purposes or potential commercial purposes to enter into a benefit-sharing agreement with each access provider for the resources. The Commonwealth is the access provider for biological resources in Commonwealth areas, as defined in the EPBC Act. The Deed constitutes a benefit sharing agreement for the purposes of Part 8A of the EPBC Regulations. The Deed, in conjunction with an access permit issued under Part 8A of the EPBC Regulations, allows the access party to take biological resources of native species (from a specified access area) for research and development on any genetic resources or biochemical compounds, comprising or contained in the biological resources.
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Contact details |
Rod Harvey, A/g Director Protected Area Policy and Biodiscovery, Parks Australia Division, Department of the Environment, Water, Heritage and the Arts, Australia, GPO Box 787 CANBERRA ACT 2601, Rod.Harvey@environment.gov.au, 02 6275 9468, 02 6274 2309 |
DEED OF AGREEMENT
BETWEEN
INSERT NAME OF ACCESS PROVIDER
AND
INSERT NAME OF ACCESS PARTY
IN RELATION TO
ACCESS TO BIOLOGICAL RESOURCES IN COMMONWEALTH AREAS AND BENEFIT SHARING
Contents
2. Effect, Commencement and Review
5. Rights in and Dealings With Samples and Products
7. Acknowledgment and Publicity
12. Access to Premises and Records
SCHEDULE 1 - PARTICULARS
SCHEDULE 2 – ACCESS AND USE CONDITIONS
SCHEDULE 3 – BENEFITS
SCHEDULE 4 – ADDITIONAL BENEFITS
DEED OF AGREEMENT
ACCESS TO BIOLOGICAL RESOURCES AND BENEFIT SHARING
DATE
This Deed is dated insert date.
PARTIES
This Deed is made between and binds the following parties:
1. NAME OF ACCESS PROVIDER of address ABN 11 111 111 111 (Access Provider)
2. NAME OF ACCESS PARTY of address ABN 11 111 111 111 (Access Party)
CONTEXT AND PURPOSE
This Deed is made in the following context:
A. The Convention on Biological Diversity and the Bonn Guidelines under it give parties to the Convention the responsibility to manage their biological diversity to ensure, inter alia, fair and equitable sharing of the benefits arising from the use of genetic resources.
B. Section 301 of the Environment Protection and Biodiversity Conservation Act 1999 (EPBC Act) provides for regulations to be made for the control of access to biological resources in Commonwealth areas, including the equitable sharing of the benefits arising from the use of biological resources in Commonwealth areas.
C. Part 8A of the Environment Protection and Biodiversity Conservation Regulations 2000 (EPBC Regulations) makes provisions for the purposes of section 301 of the EPBC Act. The regulations require access to biological resources in a Commonwealth area to be in accordance with a permit under the regulations unless the biological resources have been declared exempt. An applicant for a permit to access biological resources for commercial purposes or potential commercial must enter into a benefit-sharing agreement with each access provider for the resources.
D. The Access Party is the applicant for, or intends to apply for, a permit under Part 8A of the EPBC Regulations to access the biological resources, in the Commonwealth area or areas, specified in Schedule 2 to this Deed.
E. This Deed constitutes a Benefit Sharing Agreement for the purposes of Part 8A of the EPBC Regulations.
F. In consideration of the Access Party entering into this Deed the Access Provider grants the Access Party access to the biological resources, in the Commonwealth area or areas, specified in Schedule 2.
G. In consideration of the Access Provider granting access the Access Party will access and use the biological resources in accordance with this Deed and will provide the Access Provider with the benefits specified in Schedules 3 and 4 to this Deed.
H. This Deed, in conjunction with an access permit issued under Part 8A of the EPBC Regulations, gives the Access Party access to biological resources in the Access Area.
OPERATIVE PROVISIONS
The parties to this Deed agree as follows:
1.1.1. In this Deed, unless the context indicates otherwise:
Access Area |
means the Commonwealth area or areas specified in Schedule 2 where the Access Party may have access to biological resources; |
Access Party |
means the person or persons (individual or organisation) named as the Access Party and includes their officers, employees, agents and contractors, or any of them, where the context permits; |
Access Provider |
means the person or persons (individual or organisation) named as the Access Provider and includes their officers, employees, agents and contractors, or any of them, where the context permits; |
access to biological resources |
has the meaning given by the EPBC Regulations and means the taking of biological resources of native species for research and development on any genetic resources, or biochemical compounds, comprising or contained in the biological resources, but does not include activities described in regulation 8A.03(3); |
access permit |
means a permit issued in accordance with Part 17 of the EPBC Regulations, for the purposes of Part 8A of the Regulations, authorising access to biological resources in the Access Area; |
biological resources |
has the meaning given by the EPBC Act and includes genetic resources, organisms, parts of organisms, populations and any other biotic component of an ecosystem with actual or potential use or value for humanity; |
Business Day |
in relation to the doing of any action in a place, means a weekday other than a public holiday in that place; |
Commencement Date |
means the date of this Deed; |
Commonwealth area |
has the meaning given by section 525 of the EPBC Act; |
Confidential Information |
means: a. any information described as confidential in Schedule 1 to this Deed; and b. any information that is agreed between the Parties after the Date of this Deed as constituting Confidential Information for the purposes of this Deed; |
Deed |
means this Deed, the Schedules to this Deed and any attachments; |
EPBC Act |
means the Environment Protection and Biodiversity Conservation Act 1999 |
EPBC Regulations |
means the Environment Protection and Biodiversity Conservation Regulations 2000 |
Exploitation Revenue |
means any monies received by the Access Party from third parties arising from the Access Party’s use of biological resources, including monies received for: a. transferring, delivering, or providing access to Samples or Products; or b. assigning or granting rights (including Intellectual Property) in Samples or Products; c. Sale but not including funds received by the Access Party for the explicit purpose of research. |
genetic resources |
has the meaning given by the EPBC Act and means any material of plant, animal, microbial or other origin that contains functional units of heredity and that has actual or potential value for humanity; |
Intellectual Property |
Includes: a. copyright b. all rights in relation to inventions (including patent rights) c. all rights in relation to plant varieties (including plant breeders rights); d. registered and unregistered trademarks (including service marks), designs, and circuit layouts, and e. all other rights resulting from intellectual activity; f. know-how (whether patentable or not); |
Material |
means any matter or thing the subject of any category of property rights including Intellectual Property; |
Product |
means Material produced, obtained, extracted or derived through R & D Activity; |
R & D Activity |
means research or development on a Sample or Product; |
Sample |
means a sample of biological resources collected from the Access Area under a permit issued in conjunction with this Agreement; |
Sale |
means a payment received by the Access Party from a third party in consideration of the transfer to the third party of: a. Products; or b. Material containing a Product, by way of retail sale; |
Threshold Payment |
means the percentage of gross Exploitation Revenue to be paid by the Access Party to the Access Provider in accordance with this Deed; |
1.2.1. In this Deed, unless the contrary intention appears:
a. words importing a gender include any other gender
b. words in the singular include the plural and words in the plural include the singular
c. clause headings are inserted for convenient reference only and have no effect in limiting or extending the language of provisions to which they refer
d. words importing a person include a partnership and a body whether corporate or otherwise
e. all references to dollars are to Australian dollars
f. a reference to any legislation or legislative provision includes any statutory modification substitution or re-enactment of such legislation or legislative provision
g. where any word or phrase is given a defined meaning, any other part of speech or other grammatical form in respect of that word or phrase has a corresponding meaning
h. reference to an Item is to an Item in a schedule
i. the schedules and any attachments form part of this Deed
j. reference to a schedule (or an attachment) is a reference to a schedule (or an attachment) to this Deed, including as amended or replaced from time to time by agreement in writing between the parties and
k. a reference to writing means any representation of words, figures or symbols, whether or not in a visible form.
1.3. Guidance on Construction of this Deed
1.3.1. This Deed records the entire agreement between the parties in relation to its subject matter.
1.3.2. This Deed may only be varied by a formal deed of variation executed by both parties.
1.3.3. As far as possible all provisions must be construed so as not to be invalid, illegal or unenforceable.
1.3.4. If anything in this Deed is unenforceable, illegal or void then it is severed and the rest of this Deed remains in force.
1.3.5. Any reading down or severance of a particular provision does not affect the other provisions of this Deed.
1.3.6. If a provision cannot be read down, that provision will be void and severable and the remaining provisions will not be affected.
1.3.7. A provision of this Deed will not be construed to the disadvantage of a Party solely on the basis that it proposed that provision.
2. Effect, Commencement and Review
2.1. Deed Subject to Issue of Permit
2.1.1. This Deed takes effect only if an access permit is issued to the Access Party for the proposed access to biological resources to which the Deed relates.
2.1.2. This Deed commences on the date a permit is issued to the Access Party to access biological resources to which the Deed relates.
2.2. Review
2.2.1. The operation of this Deed will be reviewed at the request of either party.
2.2.2. The first review may be conducted 2 years after the Commencement Date, and further reviews may be conducted at intervals not less than 2 years.
2.2.3. The timing and form of reviews will be agreed between the parties.
2.2.4. Either party may request that a review be conducted by an independent person agreed by the parties, and the other party will accede to that request.
2.2.5. Where a review is conducted by an independent person:
a. the parties will provide all reasonable assistance to, and respond to all reasonable requests for information and assistance from, the person conducting the review; and
b. the cost of the review will be borne by the party requesting the review unless both parties agree beforehand to share equally the costs of the review.
2.2.6. The requirements of this Deed relating to Confidential Information will apply to the conduct of a review and the parties will take all practicable steps to ensure that the person conducting a review complies with those requirements.
2.2.7. The parties will discuss the findings and recommendations of each review and may agree to vary the terms and conditions of this Deed in accordance with clause 1.3.2.
3. Benefit Sharing
3.1. Benefits to be Provided
3.1.1. The Access Party will provide the Access Provider with the benefits specified in Schedule 3.
3.1.2. The Access Party will provide the Access Provider with the additional benefits (if any) specified in Schedule 4.
3.1.3. Where the access to biological resources under this Deed leads to the discovery of new taxa, the Access Party must offer voucher specimens for permanent loan to an Australian public institution that is a repository of taxonomic specimens of the same order or genus as those collected.
3.1.4. In offering voucher specimens for permanent loan, the Access Party may set reasonable conditions for use of the loaned specimens.
3.1.5. The operation of this clause survives the expiration or earlier termination of this Deed.
4.1. Standards
4.1.1. In performing this Deed the Access Party will:
a. comply with the conditions specified in Schedule 2;
b. carry on its activities to a high standard and in accordance with relevant best practice, including any policies, codes of practice or guidelines specified in Schedule 1 or notified by the Access Provider from time to time;
c. comply with the conditions of the Access Party’s access permits;
d. comply with all relevant laws of the Commonwealth and any applicable laws of the States, Territories or local government;
e. obtain and hold all necessary approvals and licences;
f. liaise with the Access Provider, provide any information the Access Provider may reasonably require and comply with any reasonable request made by the Access Provider; and
4.2. Animal Ethics
4.2.1. Where any activity under this Deed involves the use and care of living non-human vertebrate animals or tissue for scientific purposes, the Access Party will obtain review of and approval for such scientific purposes from a recognised animal ethics committee operating under the Australian Code of Practice for the Care and Use of Animals for Scientific Purposes or equivalent body.
4.2.2. The Access Party will comply with all laws, policies, codes of practice and guidelines relating to animal welfare as they apply to the jurisdiction where the research will be undertaken.
5. Rights in and Dealings with Samples and Products
5.1. Rights In Samples and Products
5.1.1. Subject to this clause, as between the parties the Access Party has the exclusive rights to all Samples and Products.
5.2. Intellectual Property
5.2.1. As between the Access Provider and the Access Party (but without affecting the position between the Access Party and a third party) Intellectual Property arising from R&D Activity is vested or will vest in the Access Party.
5.3. Dealings with Samples and Products and Intellectual Property
5.3.1. Without limiting clause 5.2.1, the Access Party may grant third parties the right to exploit the Intellectual Property arising from R&D Activity.
5.3.2. The Access Party will not:
a. transfer, deliver or provide access to Samples or Products; or
b. transfer, assign or grant rights (including Intellectual Property) in Samples or Products,
to a third party unless:
c. it does so under an agreement on proper terms, being terms consistent with this Deed so far as practicable and which would normally be contained in a contract, agreement or transaction between persons dealing with each other at arms length and from positions of comparable bargaining power; or
d. the third party has entered into an agreement with the Access Provider, or provided an enforceable undertaking to the Access Provider, to provide the Access Provider with the benefits and to comply with the requirements of this clause 5.3.2 in the event of any further dealing;
5.3.3. An agreement under clause 5.3.2.c must ensure the Access Provider will continue to receive an equitable share of the benefits arising from subsequent use of the Samples or Products, or the rights in those Samples or Products by the third party and any subsequent parties.
5.3.4. An agreement under clause 5.3.2.c relating to use of Samples or Products or associated Intellectual Property by a third party for non-commercial purposes must include an undertaking not to carry out, or allow others to use the Material for commercial purposes unless a benefit-sharing agreement has been entered into with the Access Party
5.3.5. The Access Party must provide the Access Provider with the name of each third party that an agreement is made with under clause 5.3.2 and details of the terms of the agreement.
5.4. Exploitation Revenue and Threshold Payments
5.4.1. Exploitation Revenue received by the Access Party is subject to the Threshold Payment requirements under Schedule 3.
6.1. Payments by the Access Party
6.1.1. Moneys payable by the Access Party to the Access Provider under this Deed will be paid annually following delivery of Annual Reports in accordance with this Deed and within 28 days following receipt of a correctly rendered tax invoice.
6.2. Taxes, Duties and Government Charges
6.2.1. Subject to this clause, all taxes, duties and government charges imposed or levied in Australia or overseas in connection with this Deed must be borne by the party liable for them.
6.2.2. Amounts payable by the Access Party to the Access Provider under this Deed will include an amount to cover any liability of the Access Provider for GST on any supplies made by the Access Provider under this Deed which are taxable supplies within the meaning of the GST Act.
6.2.3. In relation to taxable supplies made under this Deed, the Access Provider will issue the Access Party a tax invoice in accordance with the GST Act.
6.2.4. In this clause:
a. GST has the meaning given to it in the GST Act
b. GST ACT means A New Tax System (Goods and Services Tax) Act 1999 (Cth).
7. Acknowledgment and Publicity
7.1. Acknowledgement and Publicity
7.1.1. The Access Party will acknowledge the provision of access to biological resources in Commonwealth areas in all dealings with third parties with respect to R & D Activity.
7.1.2. The Access Party will ensure that an agreement with a third party under clause 5.3.2.c includes a requirement that the third party acknowledges the Access Provider is the access provider to the source Sample.
7.1.3. The operation of this clause survives the expiration or earlier termination of the Term of this Deed.
8.1. Accounts and Records
8.1.1. The Access Party will maintain complete, accurate and up to date accounts and records in relation to this Deed that:
a. include appropriate audit trails for transactions performed;
b. separately record all receipts;
c. be kept in such a manner that permits them to be conveniently and properly accessed and audited;
d. be drawn in accordance with generally accepted accounting practices and standards.
8.1.2. Without limiting clause 8.1.1 the Access Party accounts and records will enable tracking of Exploitation Revenue to ensure correct delivery of Threshold Payments to the Access Provider.
8.1.3. The Access Party must hold accounts and records in relation to the provision of the Samples for a period of 7 years from the date of expiry or termination of this Deed.
8.1.4. The operation of this clause survives the expiration or earlier termination of the Term of this Deed.
8.2. Collection Reports
8.2.1. Within six (6) months of collecting Samples under this Deed, or on or before 31 March first occurring after collection, whichever is the later, the Access Party will provide a report to the Access Provider containing the following records for each Sample taken:
a. for each record about a Sample, a unique identifier for the sample that is also on a label attached to the sample or its container;
b. the date the Sample was taken;
c. the place from which the Sample was taken;
d. an appropriate indication of the quantity or size of the Sample;
e. the scientific name of, or given to, the Sample;
f. the location of the Sample when first entered in the record;
g. the details about any subsequent disposition of the Sample, including the names and addresses of others having possession of the Sample or a part of the Sample.
8.2.2. Where a report under clause 8.2.1 includes a Sample of an undescribed species the Sample must be given a unique identifier, and the Access Party must subsequently advise the Access Provider the scientific name of, or given to, the Sample when described.
8.2.3. A Collection Report may be included in an Annual Report provided under Clause 8.3.
8.3. Annual Reports
8.3.1. The Access Party will provide an initial Annual Report to the Access Provider on activities under this Deed in the period from the date this Deed commences to the end of the calendar year immediately following completion of the collection of Samples. The report will include, but need not be limited to, the following information for the reporting period:
a. identification of this Deed as the Benefit Sharing Agreement to which the report relates;
b. a summary of all Samples collected under this Deed (including collection locations, summary of taxa collected and isolated);
c. results of research on the biology of the taxa and ecology assessments of populations from which the Samples were collected;
d. species inventories, ecological data and imagery for sites sampled;
e. summary of screening results;
f. summary of structures found;
g. publications and conference presentations arising from research into the Samples;
h. research opportunities and capacity building opportunities provided in Australia;
i. progress in establishing third party agreements as they relate to the Samples;
j. Exploitation Revenue received from third parties and the Threshold Payments payable to the Access Provider; and
k. Disposal of Samples and Products.
8.3.2. Subsequent Annual Reports will report on activities for the preceding calendar year (the reporting period) and will include, but need not be limited to, the following information for the reporting period
a. identification of this Deed as the Benefit Sharing Agreement to which the report relates;
b. results of research on the biology of the taxa and ecology assessments of populations from which the Samples were collected;
c. species inventories, ecological data and imagery for sites sampled not included in previous Annual Reports;
d. summary of screening results;
e. summary of structures found;
f. publications and conference presentations arising from research into the Samples;
g. the progress toward commercialisation of Products;
h. research opportunities and capacity building opportunities provided in Australia;
i. progress in establishing third party agreements as they relate to the Samples and Products;
j. Exploitation Revenue received from third parties and the Threshold Payments payable to the Access Provider; and
k. Disposal of Samples and Products.
8.3.3. Annual Reports will be provided on or before 31 March in the year following the year to which the report relates.
8.4. Other Reports
8.4.1. The Access Party will provide such other reports as may reasonably be requested by the Access Provider from time to time.
8.5. Form of Reports
8.5.1. Annual Reports will be provided by the Access Party in two Parts:
a. the first part will only contain information considered by the Access Party to be non-confidential and may be made available to the public by the Access Provider without prior consent of the Access Party, and may be published by the Access Party for publicity purposes;
b. the second part will contain information the Access Party reasonably requires to be treated as commercial-in-confidence for the purpose of protection of Intellectual Property,
and any material identified as commercial-in-confidence will be Confidential Information for the purposes of this Deed.
8.5.2. All reports provided by the Access Party under this Deed will be provided in hard copy and digital copy.
9.1.1. Subject to clause 9.1.5, a Party must not, without the prior written consent of the other Party, use or disclose any Confidential Information of the other Party.
9.1.2. In giving written consent to use or disclose its Confidential Information, a Party may impose such conditions as it thinks fit, and the other Party agrees to comply with these conditions.
9.1.3. A Party may at any time require the other Party to arrange for the other Party’s employees, servants or agents to give a written undertaking in the form of a Deed relating to the use and non-disclosure of the first Party’s Confidential Information.
9.1.4. If a Party receives a request under clause 9.1.3, it must promptly arrange for all such undertakings to be given.
9.1.5. The obligations on a Party under this clause will not be taken to have been breached to the extent that Confidential Information:
a. is disclosed by a Party to its employees, servants or agents solely in order to comply with obligations, or to exercise rights, under this Deed;
b. is disclosed to a Party’s internal management personnel, solely to enable effective management or auditing of activities related to this Deed;
c. is shared by a Party within its organisation, where this serves the Party’s legitimate interests;
d. is disclosed by a Party, in response to a request by a House or a Committee of the Parliament of the Commonwealth of Australia;
e. is authorised or required by law to be disclosed;
f. is disclosed by a Party and is information in a material form in respect of which an interest, whether by licence or otherwise, in the Intellectual Property Rights in relation to that material form, has vested in, or is assigned to, the Party under this Deed or otherwise, and that disclosure is permitted by that licence or otherwise; or
g. is in the public domain otherwise than due to a breach of this clause.
9.1.6. Where a Party discloses Confidential Information to another person:
a. pursuant to clauses 9.1.5 (a), (b) or (d) – the disclosing Party must:
A. notify the receiving person that the information is Confidential Information; and
B. not provide the information unless the receiving person agrees to keep the information confidential; or
b. pursuant to clauses 9.1.5 (c) or (e) – the disclosing Party must notify the receiving person that the information is Confidential Information.
9.1.7. The obligations under this clause continue, notwithstanding the expiry or termination of the Term of this Deed:
a. in relation to an item of information described in Schedule 1 – for the period set out in the Schedule in respect of that item; and
b. in relation to any information that is agreed between the Parties after the Date of this Deed as constituting Confidential Information for the purposes of this Deed – for the period agreed by the Parties.
9.1.8. Nothing in this clause derogates from any obligation which the Access Party may have either under the Privacy Act, or under this Deed, in relation to the protection of Personal Information.
10.1.1. The Access Party indemnifies (and keeps indemnified) the Access Provider against any:
a. loss or liability incurred by the Access Provider;
b. loss of or damage to the Access Provider’s property; or
c. loss or expense incurred by the Access Provider in dealing with any claim against the Access Provider, including legal costs and expenses on a solicitor/own client basis and the cost of time spent, resources used, or disbursements paid by the Access Provider;
arising from:
d. any act or omission by the Access Party in connection with this Deed, where there was fault on the part of the person whose conduct gave rise to that liability, loss, damage, or expense;
e. any breach by the Access Party of its obligations under this Deed;
10.1.2. the Access Party’s liability to indemnify the Access Provider under this clause will be reduced proportionally to the extent that any fault on the Access Provider’s part contributed to the relevant loss, damage, expense, or liability.
10.1.3. The Access Provider’s right to be indemnified under this clause is in addition to, and not exclusive of, any other right, power, or remedy provided by law, but the Access Provider is not entitled to be compensated in excess of the amount of the relevant liability, damage, loss, or expense.
10.1.4. In this clause, “fault” means any negligent or unlawful act or omission or wilful misconduct.
10.1.5. This operation of this clause survives the expiration or earlier termination of the Term of this Deed.
11.1.1. the Access Party must, for as long as any obligations remain in connection with this Deed, have insurance as specified in Schedule 1.
11.1.2. Whenever requested, the Access Party must provide the Access Provider, within 10 Business Days of the request, with evidence satisfactory to the Access Provider that the Access Party has complied with its obligation to insure.
11.1.3. All insurance under this clause is to be taken out with an insurer recognised under Australian law, and whenever requested, the Access Party must provide the Access Provider with evidence satisfactory to the Access Provider that the Access Party has complied with its obligation to insure.
11.1.4. The operation of this clause survives the expiration or earlier termination of the Term of this Deed.
12. Access to Premises and Records
12.1. Access for Audit Purposes
12.1.1. The Access Party will give to the Access Provider, or to any persons authorised in writing by the Access Provider’s, access to premises occupied by the Access Party and permit those persons to participate in audits, inspect and take copies of any Material relevant to this Deed.
12.1.2. The rights referred to in clause 12.1.1 are subject to:
a. the provision of reasonable prior notice by the Access Provider;
b. the Access Party’s reasonable security procedures;
c. if appropriate, execution of a deed of confidentiality relating to non-disclosure of the Access Party’s Confidential Information; and
d. the Access Provider not unreasonably interfering with the Access Party’s performance under this Deed in any material respect.
12.1.3. Without in any way affecting the statutory powers of the Auditor-General under the Auditor-General Act 1997 (Cth) and subject to the provisions of that Act, the Auditor-General is a person authorised for the purposes of this clause.
12.1.4. This clause applies for the Term of this Deed and for a period of 7 years from the date of termination of this Deed.
13.1. Termination by Agreement
13.1.1. This Deed may be terminated at any time by mutual agreement in writing.
13.2. Termination on Cancellation of Permit
13.2.1. If a permit issued to the Access Party to access biological resources to which the Deed relates is cancelled the Access provider may immediately terminate this Deed by written notice to the Access party.
13.3. Termination for Default
13.3.1. If:
a. the Access Party fails to satisfy any of its obligations under this Deed;
b. the Access Party breaches any law of the Commonwealth, or of a State or Territory in relation to the subject matter of the Deed;
c. the Access Provider is satisfied that any statement made, or document provided, to the Access Provider by the Access Party is defective by reason of being incorrect, incomplete, false or misleading,
The Access Provider may immediately terminate this Deed by giving written notice to the Access Party of the termination provided:
d. the Access Provider has given notice to the Access Party; and
e. the Access Party fails within the period specified by the notice (being not less than 20 Business Days) to rectify or explain to the satisfaction of the Access provider the failure, breach or defect.
13.4. Consequences of Termination
13.4.1. If this Deed is terminated under clause 13.2.2 or 13.2.3:
a. the Access Party will not thereafter use, or cause, permit or allow to be used:
A. any Samples or Products;
B. Intellectual Property arising from R & D Activity;
b. the Access Party will deliver to the Access Provider or destroy, at the Access Provider’s discretion, all Samples and Products that are the subject of this Agreement; and
c. the Access Party’s rights in all third party agreements referred to in clause 5.3.2, are assigned to the Access Provider and the Access Party will do all things, and sign all documents, necessary to effect the assignment of those rights,
and the operation of this clause 13.2.2 survives the termination of this Deed.
13.4.2. Termination under this clause will not affect the right of the Access Party to sell Products or material containing a Product, by way of retail sale under commercial arrangements existing at the date of termination, and the Access Party’s obligation to provide Exploitation Revenue in accordance with Schedule 3 will survive the termination.
14.1. No Legal Proceedings
14.1.1. Subject to clause 14.2.2, both Parties agree not to commence any legal proceedings in respect of any dispute arising under this Deed, which cannot be resolved by informal discussion, until the procedure provided by this clause has been utilised.
14.2. Dispute Resolution Procedure
14.2.1. Both Parties agree that any dispute arising during the course of this Deed is dealt with as follows:
a. the Party claiming that there is a dispute will send the other a written notice setting out the nature of the dispute;
b. the Parties will try to resolve the dispute though direct negotiation by persons who they have given authority to resolve the dispute;
c. the Parties have 20 Business Days from the receipt of the notice to reach a resolution or to agree that the dispute is to be submitted to mediation or some alternative dispute resolution procedure; and
d. if:
A. there is no resolution of the dispute;
B. there is no agreement on submission of the dispute to mediation or some alternative dispute resolution procedure; or
C. there is a submission to mediation or some other form of alternative dispute resolution procedure, but there is no resolution within 20 Business Days of the submission, or such extended time as the Parties may agree in writing before the expiration of the 20 Business Days,
D. then, either Party may commence legal proceedings.
14.2.2. This clause does not apply to the following circumstances:
a. either Party commences legal proceedings for urgent interlocutory relief;
b. termination for default under clause 13; or
c. an authority of the Commonwealth, a State or Territory is investigating a breach or suspected breach of the law by the Access Party.
14.2.3. Despite the existence of a dispute, both Parties must (unless requested in writing by the other Party not to do so) continue to perform their respective obligations in accordance with this Deed.
14.2.4. The operation of this clause survives the expiration or earlier termination of the Term of this Deed.
15.1. Negation of Employment, Partnership and Agency
15.1.1. The Access Party agrees not to represent itself, and to use its best endeavours to ensure that its Personnel do not represent themselves, as being an officer, employee, partner or agent of the Access Provider, or as otherwise able to bind or represent the Access Provider.
15.1.2. The Access Party is not by virtue of this Deed an officer, employee, partner or agent of the Access Provider, nor does the Access Party have any power or authority to bind or represent the Access Provider.
15.2. Waiver
15.2.1. A failure or delay by a party to exercise any right it holds under this Deed will not operate as a waiver of that right.
15.2.2. A single or partial exercise by a party of any right it holds under this Deed will not prevent that party from exercising that right again or exercising that right to the extent it has not already been exercised.
15.2.3. In this clause, the word “right” means a right or remedy provided by this Deed or at law.
15.3. Assignment and novation
15.3.1. Except as otherwise provided by this Deed, the Access Party cannot novate its obligations and must not assign its rights, under this Deed without, in either case, prior approval in writing from the Access Provider, which will not be unreasonably withheld.
15.3.2. The Access Party must not consult with any other person for the purposes of entering into an arrangement that will require novation of this Deed without first consulting the Access Provider.
15.4.1. Any notice, request or other communication to be given or served pursuant to this Deed will be in writing and dealt with as follows:
a. if given by the Access Party to the Access Provider - addressed as specified in Item D [Access Provider Address for Notices] of Schedule 1 or
b. if given by the Access Provider to the Access Party - addressed as specified in Item E [the Access Party Address for Notices] of Schedule 1.
15.4.2. Any notice, request or other communication is to be delivered by hand, sent by prepaid post or transmitted electronically. If it is sent or transmitted electronically, a copy is to be sent to the addressee by prepaid post.
15.4.3. A notice will only be deemed as given and received:
a. if delivered by hand, upon delivery to the relevant address
b. if sent by pre-paid ordinary post within Australia, upon the expiration of 2 business days after the date on which it was sent
c. if transmitted electronically, upon receipt by the sender of an acknowledgment that the communication has been properly transmitted to the recipient and
d. in any event, if received after 5.00pm (local time in the place of receipt) on a Business Day or on a day that is not a Business Day, on the next Business Day.
15.4.4. Either party may, by written notice to the other, change its Representative.
15.5.1. This Deed is to be construed in accordance with the laws of the insert name of the Access Provider’s State or Territory.
SIGNATURE PAGE
EXECUTED as a Deed.
SIGNED on behalf of the )
INSERT NAME OF ACCESS PROVIDER )
by insert name of signatory )
insert signatory’s position )
IN THE PRESENCE OF
insert name of witness )
SIGNED on behalf of )
INSERT NAME OF ACCESS PARTY )
by insert name of signatory )
insert signatory’s position )
IN THE PRESENCE OF
insert name of witness )
Schedule 1. - PARTICULARS
A. Applicable Policies, Codes of Practice and Guidelines (clause 4)
A.1. Please list all policies, guidelines, codes of conduct or standards which apply to the collection of Samples and subsequent research on them. The list should include any data standards or protocols that will be used in the preparation of reporting data. Examples of possible policies are: the Bonn Guidelines, the Australian Code for the Responsible Conduct of Research, the data standards for the Atlas of Living Australia (http://www.ala.org.au/datastandards.htm#LSID) protocols for research involving Traditional Knowledge and working with Indigenous people; and university ethics committee requirements (such as the Animal Ethics requirements in clause 5.2.). The Australian Government Bioethics Portal (http://www.bioethics.gov.au/) may be of assistance in identifying relevant material.
B. Confidential Information (clause 9)
B.1. The Access Provider’s Confidential Information is:
Item |
Period of Confidentiality |
|
B.2. The Access Party’s Confidential Information is:
Item |
Period of Confidentiality |
Specify confidential information and the period of confidentiality |
|
|
C. Insurance (clause 11)
C.1. Public liability insurance to the value of at least $10 million per claim, or occurrence giving rise to a claim, in respect to activities undertaken under this Deed, where occurrence means either a single occurrence or a series of occurrences if these are linked or occur in connection with one another from one original cause, as the case may be.
D. Access Party’s Address for Notices (clause 15.4)
D.1.
E. Access Party’s Address for Notices (clause 15.4)
E.1.
Schedule 2. ACCESS AND USE CONDITIONS
A. Access Area
A.1. List the areas from which the Samples will be taken, including latitude and longitude references.
B. Time and Frequency of Entry to Access Area
B.1. List the anticipated dates and times of entry to the access area(s).
C. Samples of Biological Resources to be Collected
C.1. Include name of the species, or lowest level of taxon, to which the resources belong (if known). If the species composition of Samples is not known, list the sampling method(s) and the types of organisms likely to be collected. Note that clause 8.2.1 requires that a collection report must be provided to the Access Provider within six months of the Samples being taken, or by 31 March, whichever is the later.
D. Quantity of Resources to be Collected
D.1. List the anticipated quantity of each Sample to be collected in the Access Area. Please use metric measurements.
E. Quantity of Resources to be Removed From Access Area
E.1. List the quantity of each Sample to be removed from the Access Area. Please use metric measurements.
F. Purpose of Access
F.1. Provide a brief description of the purpose(s) of collecting samples and the subsequent research that will be undertaken using them.
G. Labelling of Samples
G.1. Include a statement setting out the means of labelling the Samples.
The Regulations require that appropriate labelling of Samples must be undertaken and that records relating to the Samples collected must also be kept.
Records must include:
• a unique identifier for each sample, marked either on a label attached to the sample, or the container holding the sample.
• the date the sample was taken.
• the place from which the sample was taken.
• an appropriate indication of the quantity or size of the sample.
• the scientific name of, or given to, the sample.
• the location of the sample when first entered in the record (ie where the Sample is initially housed).
• the details about any subsequent transfer of the sample, including the names and addresses of others having possession of the sample, or a part of the sample.
H. Disposition of Ownership in Samples
H.1. Include details of any proposed transmission of samples to third parties. Third parties may include museums, research institutions, individual researchers or commercial organisations.
I. Use of Indigenous People’s Knowledge
I.1. Include details of the source of the knowledge, such as, for example, whether the knowledge was obtained from scientific or other public documents, from the access provider or from another group of indigenous persons
J. Benefits or Commitments for Use of Indigenous People’s Knowledge
J.1. If any indigenous people’s knowledge of the access provider, or other group of indigenous persons, is to be used, a copy of the agreement regarding use of the knowledge (if there is a written document), or the terms of any oral agreement, regarding the use of the knowledge
K. Proposals to Benefit Biodiversity Conservation in Access Area
K.1. Provide a statement of the benefits of the research to the conservation of biodiversity in the access areas. Benefits may include (but are not limited to) improved knowledge of: biodiversity; taxonomy; biological and ecological processes; impacts of environmental change; or data and knowledge that will assist in the conservation and management of the environment.
Schedule 3. - BENEFITS[1]
THRESHOLD PAYMENTS
A.1. Where the gross Exploitation Revenue received by the Access Party in a calendar year falls within the relevant threshold range specified in column 1 of the table below the Access Party will pay to the Access Provider the corresponding percentage of gross Exploitation Revenue specified in column 2 of the table (Threshold Payments).
Purpose of the Product |
Gross Exploitation Revenue received in one calendar year ($ Australian Dollars) |
Threshold Payment (% of gross Exploitation Revenue) |
Pharmaceutical, Nutraceutical or Agricultural |
< 500 000 500 000 – 5 000 000 > 5 000 000 |
0 2.5 5.0 |
Research |
> 200 000 or < 100 000 100 000 – 3 000 000 > 3 000 000 |
2.5 0 1.0 3. |
Industrial, Chemical, Diagnostic or Other |
> 200 000 or < 100 000 100 000 – 3 000 000 > 3 000 000 |
1.5 0 1.0 2.0 |
A.2. Threshold payments will be paid annually by the Access Party within 28 days after receipt of a correctly tendered tax invoice.
B. OFFERS OF SPECIMENS
B.1. The Access Party will offer a taxonomic duplicate of each Sample taken to an Australian public institution which has a statutory responsibility to maintain biological collections, or another institution approved by the Access Provider, that is a repository of taxonomic specimens of the same order or genus as those collected for permanent loan.
B.2. Within 3 months of the date of offer under B1, the Access Party must notify the Access Provider of the name of the Australian public institution(s) to which the duplicate Sample(s) have been offered, the date of the offer, a list of the Sample(s) offered and indicate which Samples were accepted by that institution.
B.3. The Access Party agrees that the offer of a taxonomic duplicate of Samples to an institution will include that they may be used for genetic analysis for the International Barcode of Life project.
B.4. The Access Party may impose reasonable conditions on offers made under B1and B3 including, without limiting the generality of the foregoing that the receiving institution may only use the specimens for non-commercial purposes.
C. KNOWLEDGE TRANSFER
C.1. The Access Party agrees that knowledge and information, which is not Confidential Information, contained in reports to the Access Provider, that is relevant to the taxonomy, conservation or sustainable use of biological diversity may be transferred to Australian research institutions, the Atlas of Living Australia, the Census of Marine Life, managers of Commonwealth areas, or to Indigenous Access Providers for non-commercial purposes.
D. PUBLICATIONS
D.1. The Access Party will notify the Access Provider of publications arising from research involving the Samples and supply an electronic or hard copy of such publications on request.
Schedule 4. – ADDITIONAL BENEFITS
A range of monetary and non-monetary benefits may be provided in return for access to biological resources. A broad range of benefits are outlined in the Convention on Biological Diversity’s ‘Bonn Guidelines on Access to Genetic Resources and Equitable Sharing of the Benefits Arising out of their Utilization’ (http://www.cbd.int/doc/publications/cbd-bonn-gdls-en.pdf). The following clauses are offered by way of example only.
A. AD HOC RESEARCH
A.1. The Access Party will keep the Access Provider aware of all field trips that will include access to biological resources in the Access Area.
A.2. The Access Provider has the option to request that additional research be conducted on these field trips.
A.3. The Access Provider will meet the reasonable costs of additional research under clause A.2 with terms and conditions to be negotiated with the Access Party separately to the negotiations around this Deed.
B. RESEARCH FUNDING
B.1. The Access Party will provide research funding to a local research institution to conduct research on species collected as Samples or the ecosystem from which they were collected.
C. JOINT VENTURES
C.1. The Access Party will enter into a joint venture with
a. an Australian research institution to conduct research on species collected as Samples or the ecosystem from which they were collected;
b. an Australian company or research institution to undertake bioactivity screening, preclinical and/or clinical trials or otherwise develop commercial products containing the Sample or a Product.
D. Capacity-building
D.1. The Access Party will transfer to an Australian research institution or to Indigenous Access Providers knowledge to make use of genetic resources, including biotechnology, or knowledge that is relevant to the conservation and sustainable use of biological diversity.
E. Technology Transfer
E.1. The Access Party will transfer to an Australian research institution technology to make use of genetic resources, including biotechnology, or technology that is relevant to the conservation and sustainable use of biological diversity. The terms of transfer will be negotiated with the receiving institution, and should be developed under fair and favourable terms, including concessional and preferential terms.
F. SCIENTIFIC RESEARCH AND DEVELOPMENT PROGRAMMES
F.1. The Access Party will collaborate with Australian research institutions and contribute to scientific research and development programmes, particularly biotechnological research activities.
REPLY TO WIPO/GRTKF/IC/Q.6
Question 1: Please give the contract title.
Response:
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Yes/No
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Commercial or Industrial Application
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X
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Other: Please list below:
The purpose of the agreement is to document mutually agreed terms for commercial or potentially commercial use of native genetic and biochemical resources.
|
|
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Yes/No
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Plant Genetic Resources
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X
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Animal Genetic Resources
|
X
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Microbial Genetic Resources
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X
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Uncharacterized Genetic Material transferred inadvertantly
e.g., microbes or parasites present in samples of plant material
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X
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Associated Traditional Knowledge and Know-How
|
X
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Clause(s) relating to:
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Please set out relevant clause(s) or summary of clause(s) including, if appropriate, explanation of the context of the clause(s) in relation to the contract and/or project as a whole
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Industrial property incl. patents, trademarks, geographical indications and appellations of origin, etc.
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Refer to Clause 5, in particular
5.2 Intellectual property;
5.3 Dealings with Samples and Products and Intellectual Property;
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Monetary Benefit-sharing as relates to IP: e.g. up-front payments, royalties, milestone payments, ethno-botanical premiums, trust funds, etc.
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Refer to Clause 3 Benefits-sharing, outlines benefits to be provided
Refer to Schedule 3 Benefits
Refer to Clause 5.4 Exploitation revenue and threshold payments
The mechanism of providing specified monetary benefits is outlined in Clause 5.4 and Clause 6.
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Non monetary Benefit-sharing as relates to IP: e.g. IP-related training, technology transfer, exchange of results, etc.
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Refer to Clause 3 Benefits-sharing, outlines benefits to be provided in general
Refer to Schedule 4
Benefits are determined by the parties to the contract, on mutually agreed terms, and can include contributions to conservation and scientific knowledge or any other agreed benefit as well as any revenue generated by the Commercialisation of IP related to the genetic resource (where this is relevant).
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Ongoing traditional and customary use: i.e. clarification of future use of genetic resources and any associated traditional knowledge by local peoples or traditional communities, such as farmers’ rights.
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These must be specified in Schedule 2 (I and J)
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Termination (insofar as it relates to IP).
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Refer to Clause 13 - Termination (in particular 13.4.1)
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Other. Please list below:
e.g. publications, exclusivity of supply, future supply of resources in the event of successful research, etc.
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Refer to Clause 7 - Acknowledgement and Publicity
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Existing Laws and Regulations
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Please state name and date of law and, if possible, relevant clause number(s)
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National laws and regulations in provider country
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Section 301 of the Environment Protection and Biodiversity Conservation Act 1999 (EPBC Act) provides for regulations to be made for the control of access to biological resources in Commonwealth areas, including the equitable sharing of benefits arising from the use of the biological resources in Commonwealth areas.
Part 8A of the Environment Protection and Biodiversity Conservation Regulations 2000 (EPBC Regulations) require an applicant for a permit to access biological resources for commercial purposes or potential commercial purposes to enter into a benefit-sharing agreement with each access provider for the resources.
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Regional laws and regulations
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In addition to the legislation covering Commonwealth areas, the Queensland and Northern Territory Governments have legislation in place related to accessing genetic resources and benefit-sharing (i.e. Queensland - The Biodiscovery Act 2004; and the Northern Territory Biological Resources Act 2006. Victoria and Tasmania are recently implementing legally effective measures to implement Australia's nationally consistent approach to access and benefit sharing.
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Other
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Other related guidelines and policies:
- Nationally consistent approach for access to and the utilisation of Australia's native genetic and biochemical resources, endorsed on 11 October 2002 by National Resource Management Council; Refer to website address -http://www.environment.gov.au/biodiversity/publications/access/nca/index.html
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Question 22: Please share any “lessons learned” arising from your work in the field of contractual agreements for access to genetic resources and benefit-sharing.