Regulation, 2025

Text

Reproduced from the document India Code holds for this instrument. The Gazette prints Hindi and English side by side and this is the English; the Department's own PDF remains the authority.

EXTRAORDINARY

PART III—Section 4

PUBLISHED BY AUTHORITY

No. 332] NEW DELHI, WEDNESDAY, APRIL 30, 2025/VAISAKHA 10, 1947 [पता] ________________________________________________ [पता] ________________________________________________

NATIONAL BIODIVERSITY AUTHORITY

NOTIFICATION

Chennai, the 29th April, 2025 F. No. NBA/Tech/EC/9/14/32/.—In exercise of the powers conferred by section 64 read with sub-section (1) of section 18 and sub-section (4) of section 21 of the Biological Diversity Act, 2002 (18 of 2003)and in supersession of the Guidelines on Access to Biological Resources and Associated Knowledge and Benefits Sharing Regulations, 2014, except as respects things done or omitted to be done before such supersession, the National Biodiversity Authority, with the approval of the Central Government, hereby makes the following regulations, namely:—

1. Short title and commencement.—(1) These regulations may be called the Biological Diversity (Access to Biological Resources and Knowledge Associated thereto and Fair and Equitable Sharing of Benefits) Regulations,

(2) They shall come into force on the date of their publication in the Official Gazette. 2.Definitions. — (1) In these regulations, unless the context otherwise requires,–

(a) ―Act‖ means the Biological Diversity Act, 2002 (18 of 2003);

(b) "authorised officer" means any officer authorised by the Authority or State Biodiversity Board or Union territory Biodiversity Council for the purposes of this regulations;

(c) ―Authority‖ means the National Biodiversity Authority established under sub-section (1) of section 8 of the Act;

(d) ―Board‖ means the State Biodiversity Board established under sub-section (1) of section 22 of the Act;

(e) ―Committee‖ means a Biodiversity Management Committee established under sub-section (1) of section 41 of the Act;

(f) ―Council‖ means the Union territory Biodiversity Council established under sub-section (2) of section 22 of the Act;

(g) ―fee‖ means any fee as specified in the First Schedule to the Biological Diversity Rules, 2024;

(h) ―rules‖ means the Biological Diversity Rules, 2024;

(i) ―Tribunal‖ means the National Green Tribunal established by section 3 of the National Green Tribunal Act, 2010 (19 of 2010);

(j) ―upfront payment‖ means any amount to be paid before accessing the biological resource or knowledge associated thereto by the applicant.

(2) The words and expressions used but not defined in these Regulations and defined in the Act or Rules shall have the meaning respectively assigned to them in the Act and Rules.

3. Mode of benefit sharing for accessing biological resource including digital sequence information or knowledge associated thereto for research or bio-survey and bio-utilisation under section 3 of the Act.—(1) In case a biological resource including digital sequence information or knowledge associated thereto, having conservation value or high economic value such as red sanders, sandalwood, agarwood or any other items as decided by the Authority from time to time, and including threatened species notified under section 38 of the Act, is accessed for research or for bio-survey and bio-utilisation, the benefit sharing including the upfront payment may be determined by the Authority:

Provided that the Authority may also require upfront payment on certain biological resources including digital sequence information or knowledge associated thereto, when accessed for research or for bio-survey and bio- utilisation, on case to case basis:

Provided further that in case a biological resource including digital sequence information or knowledge associated thereto, is accessed for conducting academic research, the Authority may waive the benefit sharing including upfront payment, as it deems fit, on case to case basis.

4. Mode of benefit sharing for access to biological resource or associated knowledge for commercial utilisation under section 3 of the Act.—(1) When the biological resource including digital sequence information or knowledge associated thereto, is accessed for commercial utilisation, the applicant shall have to pay benefit sharing amount as per the Table given below:— Table Sl.

No.

Annual turnover of the person (in Indian rupee) Amount payable on account of benefit sharing for access to biological resource for commercial utilisation(Percentage of annual gross ex-factory sale price of product excluding Government taxes)

1. Up to 5 crore Nil

2. Above 5 crore to 50 crore 0.2%

3. Above 50 crore to 250 crore 0.4%

4. Above 250 crore 0.6%

(2) Any person having an annual turnover of more than one crore rupees shall submit an annual statement containing information regarding the biological resource consumed in the financial year in Form A, within three months of finalisation of annual income tax or corporate tax return in respect of that financial year.

(3) The person liable to pay benefit sharing amount under this regulation shall make the payment digitally through web portal.

(4) In case of biological resource having conservation value or high economic value such as red sanders, sandalwood, agarwood or any other items as decided by the Authority from time to time, and including threatened species notified under section 38 of the Act, the benefit sharing shall not be less than five percent. of the proceeds of the auction or sale amount or the purchase price, as the case may be, as determined by the Authority on case to case basis, as upfront payment:

Provided that in case of biological resource having conservation value or high economic value such as red sanders, sandalwood, agarwood or any other items as decided by the Authority from time to time, and including threatened species notified under section 38 of the Act, including digital sequence information or knowledge associated thereto, the benefit sharing component shall be twenty percent. more than the benefit sharing amount due as referred under sub-regulation (1) of this regulation.

5. Procedure for prior intimation for commercial utilisation by persons covered under section 7 of the Act .—

(1) Any person who intends to access biological resource including digital sequence information or knowledge associated thereto, for commercial utilisation shall give prior intimation to the Board or Council through a web portal in Form B along with the fee (two thousand rupees in case of an individual and five thousand rupees in case of an entity) and the applicant shall also give their consent to the mutually agreed terms and conditions appended to the said Form.

Provided that the provisions of section 7 of the Act shall not apply in case of access to cultivated medicinal plants as notified under section 40 of the Act.

(2) Upon submission of the prior intimation by the applicant, complete in all respect, it shall be disposed of by the Board or Council, within a period of fifteen days from the date of such submission, by either approving the request with or without modification in the mutually agreed terms and conditions in Form-C or by rejecting the request along with reasons for rejection in Form-D:

Provided that if the applicant does not sign the agreement as modified by the Board or Council, within a period of fifteen days, the application shall be closed under intimation to the applicant: Provided further that the Board or Council may revive the closed application on receipt of payment of half of the fee as applicable, within a period of ninety days:

Provided also that the application shall not be rejected unless the applicant has been given a reasonable opportunity of being heard.

(3) Any person aggrieved by the rejection of the application under sub-regulation (1), may prefer an appeal to the Tribunal.

(4) If the Board or Council does not respond to the prior intimation Form of the applicant within a period of fifteen days, it shall be deemed to have been approved for a period of one year.

(5) In case there is a dispute which could not be settled between the applicant and the Board or Council, the matter shall be referred to the Authority by the Board or Council electronically which shall be disposed of within fifteen days.

(6) Any person aggrieved by any determination of the benefit sharing or order of the Authority or Board under this Act may prefer an appeal to the Tribunal.

(7) When the biological resource including digital sequence information or knowledge associated thereto, is accessed for commercial utilisation, the applicant shall have to pay benefit sharing amount as per the Table given below.—

TABLE

Sl.

No.

Annual turnover of the person (in Indian rupee) Amount payable on account of Benefit sharing for access to biological resources for commercial utilisation[Percentage of annual gross ex-factory sale price of product excluding Government taxes]

1. Up to 5 crore Nil

2. Above 5 crore to 50 crore 0.2%

3. Above 50 crore to 250 crore 0.4%

4. Above 250 crore 0.6% Provided that, for persons manufacturing products containing both cultivated and non-cultivated medicinal plants, the benefit-sharing payment shall not be payable in respect of the products as notified by the Ministry of Environment, Forest and Climate Change, in consultation with the Authority and Ministry of Ayush, from time to time.

(8) In case of biological resource having conservation value or high economic value such as red sanders, sandalwood, agarwood or any other items as decided by the Authority from time to time, and including threatened species notified under section 38 of the Act, the benefit sharing shall not be less than five percent. of the proceeds of the auction or sale amount or the purchase price, as the case may be, as determined by the Board or Council, on case to case basis, as upfront payment:

Provided that in case of biological resource having conservation value or high economic value such as red sanders, sandalwood, agarwood or any other items as decided by the Authority from time to time, and including threatened species notified under section 38 of the Act, including digital sequence information or knowledge associated thereto, the benefit sharing component shall be twenty percent. more than the benefit sharing amount due as mentioned in sub-regulation (7) of this regulation.

(9) Any person having an annual turnover of more than one crore rupees shall submit an annual statement containing information regarding the biological resource consumed in the financial year in Form A, within three months of finalisation of annual income tax or corporate tax return in respect of that financial year.

(10) The person liable to pay benefit sharing amount in terms of this regulation shall make the payment digitally through web portal.

6. Collection fees.— Any person seeking prior approval or giving prior intimation for access to any biological resource for commercial purposes, shall pay a collection fee, as may be provided in the model guidelines formulated under clause (w) of rule 11 of the rules, on the web portal to be paid to the Committee under sub-section (3) of section 41 of the Act.

7. Mode of benefit sharing for sharing or transferring results of research relating to biological resource or traditional knowledge associated thereto.—(1)The applicant shall, in case of sharing or transfer of results of research under rule 15 of the rules shall pay to the Authority such monetary benefit or share non-monetary benefit, as agreed between the applicant and the Authority:

Provided that in case the monetary benefits have been received by the applicant, on such transfer, the applicant shall pay to the Authority up to five percent. of the monetary consideration: Provided further that in cases of sponsored projects allowed prior to the date of commencement of these regulations, where no budget had been earmarked for payment of benefit sharing, the sponsoring organisation shall give an undertaking that in case the results of research are used for commercialisation, the benefits shall be shared with the Authority and the Indian person availing sponsorship of such projects shall keep the sponsor informed of this requirement.

(2) Any person covered under section 3 of the Act, who intends to use the results of research relating to biological resource or traditional knowledge associated thereto, for commercial utilisation, shall pay the benefit sharing amount to the Authority as provided under sub-regulation (1) of regulation 4.

(3) Any person covered under section 3 of the Act, who intends to use the results of research relating to biological resource including digital sequence information or traditional knowledge associated thereto, for obtaining intellectual property rights shall pay to the Authority as given below:–

(i) when the applicant himself uses the intellectual property rights for commercialisation, the monetary benefit sharing shall be in the range of up to one percent. based on sectoral approach, which shall be worked out on the annual gross ex-factory sale price of product excluding Government taxes, on case to case basis;

(ii) when the applicant assigns or licenses the intellectual property rights to a third party for commercialisation, the applicant shall pay to the Authority up to five percent. of the fee received (in any form including the license or assignee fee) and up to five percent. of the royalty amount received annually from the assignee or licensee, based on sectoral approach, on case to case basis.

8. Mode of benefit sharing for commercialisation of intellectual property rights by persons covered under section 3 of the Act.-– (1) The applicant shall pay to the Authority such monetary benefit or share non-monetary benefit, as agreed between the applicant and the Authority:–

(i) when the applicant himself uses the intellectual property rights for commercialisation, the monetary benefit sharing shall be in the range of up to one percent. based on sectoral approach, which shall be worked out on the annual gross ex-factory sale price of the product excluding Government taxes, on case to case basis: Provided that in case the traditional knowledge is involved in the invention, the benefit sharing obligation shall be twenty-five percent. higher than the benefit sharing due: Provided further that any person, if upon cease or revocation of the intellectual property rights, intends to access the biological resource including digital sequence information or traditional knowledge associated thereto, to be used in the product or process for which intellectual property rights were obtained, for commercial utilisation, shall seek prior approval, as provided under rule 13 of the rules and share the benefits as referred to under regulation4. Explanation. —In the event of the applicant accessing biological resource for commercial utilisation during the existence of intellectual property rights, the applicant shall share the benefits only under this regulation;

(ii) when the applicant assigns or licenses the intellectual property rights to a third party for commercialisation, the applicant shall pay to the Authority up to five percent. of the fee received (in any form including the license or assignee fee) and up to five percent. of the royalty amount received annually from the assignee or licensee, based on sectoral approach, on case to case basis.

(2) Any person who intends to access the biological resource including digital sequence information, for commercialisation of the intellectual property rights, shall apply to the Authority or the Board or Council, as the case may be.

9. Mode of benefit sharing for commercialisation of intellectual property rights by persons covered under section 7 of the Act.– The applicant shall pay to the Authority such monetary benefit and or share non-monetary benefit, as agreed between the applicant and the Authority, as under,–

(i) when the applicant himself uses the intellectual property rights for commercialisation, the monetary benefit sharing shall be in the range of up to one percent. based on sectoral approach, which shall be worked out on the annual gross ex-factory sale price of the product excluding Government taxes, on case to case basis: Provided that in case the traditional knowledge is involved in the invention, the benefit sharing obligation shall be twenty-five per cent. higher than the benefit sharing due: Provided further that any person, if upon cease or revocation of the intellectual property rights, intends to access the biological resource including digital sequence information or traditional knowledge associated thereto, to be used in the product or process for which intellectual property rights were obtained, for commercial utilisation, shall seek approval and share the benefits as referred to under regulation 5. Explanation. —In the event of the applicant accessing biological resource for commercial utilisation during the existence of intellectual property rights, the applicant shall share the benefits only under this regulation.

(ii) when the applicant assigns or licenses the intellectual property rights to a third party for commercialisation, the applicant shall pay to the Authority up to five percent. of the fee received (in any form including the license or assignee fee) and up to five percent. of the royalty amount received annually from the assignee or licensee, based on sectoral approach, on case to case basis.

10. Deposition of novel microbial strain in the repositories outside India for publication.–(1) Any Indian researcher or scientist who has discovered a novel microbial strain from India and intends to deposit the same in the repositories outside India for publication in the journals for claiming novelty as per the agreed international requirements, shall apply on the web portal of the Authority in Form E as appended to these Regulations.

(2) The applicant shall deposit one voucher specimen in the designated repository as required under sub-section (3) of section 39 of the Act.

(3) The designated repositories in and outside India shall inform any user about the Indian legal requirements for obtaining prior approval of the Authority for undertaking any research or bio-survey and bio-utilisation or commercial utilisation as per section 3 of the Act:

Provided that if any researcher desires to refer to the voucher specimen for taxonomical identification purposes, such approval is not required.

(4) The applicant shall submit a copy of the acknowledgement of the receipt of voucher specimen issued by the designated repository concerned in India to the Authority.

11. Criteria for determination of benefit sharing. –(1) The benefit sharing by the applicant may be in monetary and or non-monetary modes, as mutually agreed with the Authority or the Board or Council in consultation with the Committee or the benefit claimer, on case to case basis, as provided in Form F appended to these regulations.

(2) Determination of benefit sharing under regulations 3, 4, 5,7, 8 and 9 shall be sector specific and based on considerations such as nature and quantity of biological resource used and its sustainability, ecological impact, nature of technology applied, potential commercial use of the proposed activity, etc. and the Authority shall specify the formula for determining the percentage of benefit sharing component including upfront payment to be fixed on case to case basis, for undertaking different activities:

Provided that special consideration may be given to cases where access to biological resource including digital sequence information or knowledge associated thereto is for technologies or innovations or products that are developed leading to intellectual property rights for controlling epidemics, mitigating environmental pollution affecting human, animal or plant health, or for food security or conservation of biodiversity, and in such cases, the benefit sharing may be at a lower percentage in the range, as decided by the Authority or the Board or Council, on case to case basis:

Provided further that in the event of contribution to non-monetary benefit as mutually agreed, the monetary benefit sharing obligation, if any, may be reduced, as determined by the Authority or the Board or Council.

(3) The amount of benefit sharing shall remain the same whether the product contains one or more biological resources.

(4) Where the biological resource is sourced from the jurisdiction of two or more Boards or Councils, the total amount of the accrued benefits shall be shared with the Boards or Councils concerned, proportionately, on a case to case basis.

12. Sharing of benefits among Authority, Board or Council and benefit claimer.–(1) Where approval has been granted by the Authority for research or for commercial utilisation or for sharing or transferring results of research or for intellectual property rights, the mode of benefit sharing shall be as under:—

(a) a minimum of ten percent. to maximum of fifteen percent. of the accrued benefits shall go to the Authority, out of which half of the amount may be retained by the Authority, as the case may be, and the other half may be shared with the Board or Council concerned;

(b) the remaining amount of benefit sharing shall be distributed among the benefit claimers including the Committee and in case where the biological resource including digital sequence information is accessed from an unknown source, the Authority may retain the full amount of the accrued benefit which may be utilised by the Authority in accordance with sub-section (2) of section 27 of the Act;

(c) where the biological resource including digital sequence information and or knowledge associated thereto is sourced from an individual or a group of individuals or organisations, the amount received under clause (b) shall be directly transferred to such individual or a group of individuals or organisations, in accordance with the terms and conditions of any agreement and in such manner as it deems fit.

(2) Where approval has been granted by the Board or Council, the mode of benefit sharing shall be as under:—

(a) a minimum of ten percent. to maximum of fifteen percent. of the accrued benefits shall be retained by the Board or Council;

(b) the remaining amount of benefit sharing shall be distributed among the benefit claimers including the Committee and in case the biological resource including digital sequence information is accessed from an unknown source, the Board or Council may retain the full amount of the accrued benefit, which may be utilised in accordance with sub- section (2) of section 32 of the Act;

(c) where the biological resource including digital sequence information or knowledge associated thereto is sourced from an individual or a group of individuals or organisations, the amount received under clause (b) shall be directly transferred to such individual or a group of individuals or organisations, in accordance with the terms and conditions of any agreement and in such manner as it deems fit.

(3) The interest earned on the benefit sharing amount deposited in the National Biodiversity Fund or the State Biodiversity Fund or Union territory Biodiversity Fund shall be utilised as per section 27 and section 32 of the Act, as the case may be.

(4) All penalties together with interest earned thereof accrued in the National Biodiversity Fund or the State Biodiversity Fund or the Union territory Biodiversity Fund concerned, shall be used to support conservation and sustainable use of the biological resources, promote livelihoods of the local people of the area where such biological resources occur and to undertake various activities to meet the objectives of the Act.

13. The agreement for approvals.––The terms and conditions under the agreement for approval under sections 3, 4, 6 and 7 of the Act shall amongst other things, include the following, namely:–

(a) general objectives and purpose;

(b) details of the biological resource including digital sequence information or knowledge associated thereto including accompanying information;

(c) intended uses of the biological resource including digital sequence information or knowledge associated thereto;

(d) terms and conditions for the applicant while obtaining intellectual property rights;

(e) nature and quantum of monetary or non-monetary benefits;

(f) restrictions on sharing or transferring the results of research to any third party without prior approval of the Authority;

(g) declaration by the applicant that whenever there is change in the status with regard to sub-section (2) of section 3 of the Act, intimation shall be given to the Authority or the Board or Council within a period of sixty days;

(h) undertaking by the applicant to deposit a reference sample of the biological resource to be accessed, wherever required by the Authority or Board or Council, with the repositories so designated under section 39;

(i) submission of periodic status reports by the applicant about research and other developments, as may be prescribed by the Authority or Board or Council;

(j) obligation to abide by the provisions of the Act, rules and regulations, and other related laws in force in the country;

(k) affirmation to facilitate measures for conservation and sustainable use of biological resource to be accessed;

(l) assertion to minimise environmental impacts while collecting the biological resource;

(m) legal provisions such as duration of the agreement, notice period to terminate the agreement, independent enforceability of clauses, provision regarding the extent to which the obligations relating to benefit sharing clauses survive the termination of the agreement, events limiting liability (natural calamities, etc.), arbitration, confidentiality clause, if any, etc;

(n) any other condition which the Authority or Board or Council may consider necessary for the purposes of the Act.

14. Reporting compliance with the terms and conditions of approval.– The applicant may submit a compliance report to the Authority or Board or Council in accordance with the terms and conditions under which approval is granted.

FORM A

(see regulation 4 and 5) Format of Annual statement to be filed by a person or entity covered under sub-section (2) of section 3 or section 7 of the Act having annual turn-over of more than one crore for disclosing the details of biological resource or associated knowledge used or consumed for commercial utilisation. Sl. No. Particulars Information to be furnished by the applicant

1. Category of the applicant a. Individual b. Entity

2. Name and Address of the applicant (address including PIN code, email, mobile)

3. Details of the biological resources (state-wise) i. Common / scientific name of biological resources ii. Quantity of biological resources accessed iii. Source of access (wild/cultivated/repositories) iv. Geographical location from where the biological resources are accessed.

4. Year of commercial utilisation

5. Annual Turnover of the person or entity and proof of annual turn over (duly attested by the Chartered Accountant) Upload Sl.

No.

Product/ Biological resources Financial year Details of Prior under Section 7 or

Section 3(2) of the Act Annual gross ex- factory sale price of the product Government Taxes paid, if any Annual gross ex-factory sale price minus government taxes [7=(5)-(6) Benefit sharing amount to be paid to Authority/ Board/ Council (only in respect of persons/entity liable to pay benefit sharing amount) (in INR) Undertaking

1. I declare that the relevant records shall be furnished or shared with the Authority or Board or Council, as and when required.

2. I further declare that the information provided in the form is true and correct and I shall be liable for any incorrect or wrong information and willful suppression of the facts. Date:

Signature with seal Name

FORM B

(see regulation 5) Model Application format for prior intimation to the Board or Council for access to biological resources, digital sequence information or knowledge associated thereto for commercial utilisation by persons covered under section 7 of the Act.

1. Particulars of the applicant

(i) Category of the applicant (Drop-down menu) a. Individual b. Entity

(ii) Name of the applicant

(iii) Address of the applicant (Postal address including PIN code, email, mobile and alternate mobile numbers and/or landline number)

(iv) Profile of the individual / entity ie. Nature of the business etc.

Individual- PAN/Aadhar Entity: PAN/CIN No.

(v) Annual Turnover as per the last finalized return

(vi) Details of the authorized representative for the applicant (Name with postal address including PIN code, email, mobile and alternate mobile numbers and/or landline number)

2. Details of the biological resources and knowledge associated thereto intended to be accessed (State-wise)

(i) Details of biological resource (Drop down menu) i. Nature of the biological resource iii. Scientific name (Genus and species/ variety/strain) iv. Plant parts (Seed, stem, bark, leaf, flower, fruit, root, rhizome, genetic material, extract, exudate, etc.) v. Quantity of each biological resource (in Kg/gm/ml) vi. Duration of access (expected start and end date) vii. Source of access (wild/cultivated/ institution/repository/trader/ market) viii. Geographical location (village, taluk, district, state). If procured from a trader institute, their name, address and contact details to be provided; if procured from repository / institution/ database, then origin of collection (passport data) to be provided.

(ii) Details about the knowledge associated thereto: (State-wise)

(a) Nature of the knowledge associated (Oral/ documented)

(b) Details of traditional knowledge intended to be accessed (in not more than 100 words)

(c) Name of the traditional knowledge holder (individual community)

(d) Address of the traditional knowledge holder (individual community)

3. The purpose for which access is required including the type and extent of commercial utilisation being derived and expected to be derived from it

(i) Brief description about the commercial utilisation

(ii) Expected duration of commercial utilisation

4. Whether proposed commercial utilisation is aimed for commercializing the IPR obtained Yes or No If yes, upload the copy of the approval obtained from the Authority under Section 6(1B) of the Act

5. Preferred mode of benefit sharing i. Monetary ii. Non-monetary iii. Both

6. Estimation of benefits that would flow to the country or communities arising out of the use of accessed biological resources and knowledge associated thereto (optional)

7. Any other information considered relevant

8. Details of remittance of application fee (Mode of payment, transaction ID, amount, date, etc.) Declaration I/We declare that:

1. Collection of the proposed biological resource shall not adversely affect the sustainability of the resources;

2. Collection of the proposed biological resource shall not entail any environmental impact;

3. Collection of the proposed biological resource shall not pose any risk to the ecosystems; and

4. Collection of the proposed biological resource and knowledge associated thereto shall not adversely affect the local communities.

5. I/we agree with the terms & conditions contained in the model mutually agreed terms, as prescribed by the Authority and the same has been submitted for the proposed access to biological resource and knowledge associated thereto.

I/We further declare that the information provided in the application form is true and correct to the best of my/our knowledge and belief and that it conceals nothing and that no part of it is false. I/We shall be liable for any incorrect or wrong information and willful suppression of the facts. Place Signature Date Name

FORM C

(see regulation 5) Approval with or without modifications to the mutually agreed terms and conditions [From] Office of ___________________________________________ [Address] ________________________________________________ To Please refer to your application number……………………..……dated ………………submitted to the State Biodiversity Board/ Union territory Biodiversity Council seeking approval for accessing biological resources and or knowledge associated thereto for the purpose of commercial utilisation under section 7 of the Biological Diversity Act, 2002 (18 of 2003), as amended from time to time.

2. The State Biodiversity Board/Union territory Biodiversity Council, after examination of the application and after being heard from the applicant, hereby approves the application in ……………... (Form Number and Application number) dated …………………… along with the mutually agreed terms and conditions under section 23(b) and section 24 (2) of the Biological Diversity Act, 2002 as amended from time to time. or The State Biodiversity Board/Union territory Biodiversity Council, after examination of the application and after being heard from the applicant, hereby approves the application in ……………... (Form Number and Application number) dated …………………… under section 23(b) and section 24 (2) of the Biological Diversity Act, 2002 as amended from time to time with following modifications in the terms and conditions of mutually agreed terms and conditions, namely:– You are requested to give your consent to the modified terms and conditions as proposed by the Board or Council and sign the agreementwithin a period of fifteen days failing which your application shall be closed in terms of regulation 5.

This is issued with the approval of the Competent Authority. Member Secretary (Name) State Biodiversity Board/Union territory Biodiversity Council, Copy for information and necessary action:

1. …………. (Name) Biodiversity Management Committee.

2. A copy to be uploaded on the Website of the State Biodiversity Board. Form D (see regulation 5) Order of Rejection [From] Office of ___________________________________________ [Address] ________________________________________________ To Please refer to your application number……………………..……dated ………………submitted to the State Biodiversity Board/Union territory Biodiversity Council seeking approval for accessing biological resources and or knowledge associated thereto for the purpose of commercial utilisation under section 7 of the Biological Diversity Act, 2002 (18 of 2003),as amended from time to time.

2. The State Biodiversity Board / Union territory Biodiversity Council, after examination of the application and after being heard from the applicant, hereby rejects the application in ……………...(Form Number and Application number) dated ……………………under section 23(b) and section 24 (2) of the Biological Diversity Act, 2002 as amended from time to time, due to the following reasons:–

3. As per section 52A of the Biological Diversity Act, 2002 as amended from time to time, you may file an appeal to the National Green Tribunal established under section 3 of the National Green Tribunal Act, 2010, within a period of 30 days from the date of communication of the issue of this order. This is issued with the approval of the Competent Authority. Member Secretary (Name) State Biodiversity Board / Union territory Biodiversity Council, Copy for information and necessary action:

1. …………. (Name) Biodiversity Management Committee.

2. A copy to be uploaded on the Website of the State Biodiversity Board.

FORM E

(See regulation 10) Application for giving prior intimation to the National Biodiversity Authority for deposition of microorganism by an Indian researcher in repositories outside India for claim of discovery of novel strain from India for publication Sl.

No.

Particulars Information to be furnished

1. Name of the applicant (Depositor)

2. Category of the applicant (a) Individual researcher

(b) Institution

3. Complete address with contact details (Postal address including PIN code, email, mobile and alternate mobile numbers and or landline number)

4. Name of the microorganism to be deposited in the foreign repository

5. Geographical location from where the microorganism was/ were collected

6. Name and contact details of the foreign repository from where the biological resource are to be deposited (Postal address including PIN code, email, mobile and alternate mobile numbers and or landline number)

7. Name and contact details of the Indian repository where the biological resources are deposited (Postal address including PIN code, email, mobile and alternate mobile numbers and or landline number)

8. Accession number allotted by the Indian repository to the deposited microorganism Declaration I/We………declare that I shall inform the foreign repository that any non-Indian user to access the microorganism so deposited with the repository for undertaking research or for bio-survey and bio-utilisation or for commercial utilisation shall obtain prior approval from the National Biodiversity Authority as per the provisions of the Act. I further declare that I am not a person covered under sub-section (2) of section 3 of the Act. I also declare and solemnly affirm that the information provided above is true and correct to the best of my knowledge and belief. I/We shall be liable for any incorrect or wrong information and willful suppression of the facts. Place:

Date:

Signature of the applicant (depositor)

FORM F

Fair and equitable benefit sharing options (See regulation 11) The following options, either one or more, may be applied in accordance with mutually agreed terms between the applicant and the National Biodiversity Authority or State Biodiversity Board or Union territory Biodiversity Council, on case to case basis, in accordance with the provisions of sections 21 and 23 of the Act. These options are indicative in nature and other options, as approved by the National Biodiversity Authority in consultation with the Central Government, may also be adopted:

(a) Monetary benefits options:

i. Upfront payment;

iii. Milestone payments;

iv. Share of the royalties and benefits accrued;

v. Share of the license fees;

vi. Contribution to National or State or Union territory or Local Biodiversity Funds; vii. Funding for research and development in India;

viii. Joint ventures with Indian institutions and companies.

(b) Non-monetary benefits options:

i. Providing institutional capacity building, including training on sustainable use practices, creating infrastructure (including disposal of waste/composting for a clean environment, providing safe drinking water/solar powered lights) and undertaking development of works related to conservation and sustainable use of biological resources;

ii. Transfer of technology or sharing of research and development results with Indian institutions/ individuals/entities; providing green technologies to the local people/communities; iii. Remediation and restoration activities to prevent habitat destruction or pollution or contamination of areas; iv. Strengthening of capacities for developing technologies and transfer of technology to India and/or collaborative research and development programmes with Indian institutions/individuals/entities; v. Contribution/collaboration related to education and training in India on conservation and sustainable use of biological resources;

vi. Setting up of production, research, and development units/facilities contributing to the local economy and income generation for the local communities;

vii. Taking appropriate measures for conservation and protection of species including rare, endangered and threatened species by raising nurseries and/or plantations in the area from where biological resources have been accessed;

viii. Instituting studies/projects on inventorisation and resource assessment of biodiversity; ix. Sharing of scientific information relevant to conservation and sustainable use of biological diversity including biological inventories and taxonomic studies;

x. Conducting research directed towards priority needs in India including food, health and livelihood security focusing on biological resources;

xi. Providing scholarships including living costs, etc., to individuals and financial aid to Indian institutions preferably to regions, tribes/sects contributing to the delivery of biological resources and subsequent profitability, if any;

xii. Setting up of venture capital fund for aiding the cause of benefit claimers; xiii. Joint ownership of relevant intellectual property rights; xiv. Salaries and preferential terms where mutually agreed.

and Published by the Controller of Publications, Delhi-110054.

SARVESH KUMAR SRIVASTAVA

Provisions this regulation answers to

Read out of the instrument itself: an enabling provision is one it says it was made under, which is the power it rests on. The rest it names without resting on.

Other instruments under the same Act

All of the The Biological Diversity Act, 2002