Protection of Traditional Knowledge, Genetic Resources and Expressions of Folklore Regulations, 2021 (S.I. No. 61 of 2021)

1. Title

2. Interpretation PART II APPLICATION FOR REGISTRATION OF TRADITIONAL KNOWLEDGE OR EXPRESSIONS OF FOLKLORE

3. Registration of traditional knowledge or expressions of folklore

4. Objection to an application for registration of traditional knowledge or expressions of folklore

5. Request for further particulars

6. Determination of an objection

7. Registration of traditional knowledge or expressions of folklore

8. Certificate of registration

9. Access to registered traditional knowledge or expressions of folklore

10. Application for approval of li censing agreement Copies of this Statutory Instrument can be obtained from the Government Printer, P.O. Box 30136, 10101 Lusaka. Price K104.00 each. 536 Statutory Instruments 14th May, 2021 PART III ACCESS TO GENETIC RESOURCES

11. Application for prior informed consent

12. Access permit or exploration permit PART IV GENERAL PROVISIONS

13. Access agreement

14. Objection to access agreement

15. Approval or rejection of access agreement

16. Alteration suspension or termination of access agreement

17. Compulsory licence

18. Appointment of agent

19. Request for information from Register

20. Notification of change of particulars

21. Application for duplicate certificate

22. Application for amendment or correction of document

23. Competent National Authority and National Focal Point

24. Fees SCHEDULES 14th May, 2021 Statutory Instruments 537 IN EXERCISE of the powers contained in sections 29 and 73 of the Protection of Traditional Knowledge, Genetic Resources and Expressions of Folklore Act, 2016 the following Regulations are made:

1. These Regulations may be cited as the Protection of Title Traditional Knowledge, Genetic Resources and Expressions of Folklore Regulations, 2021.

2. In these Regulations, unless the context otherwise requires Interpretation “agent” means a legal practitioner or person registered as a patent agent under the Patents Act, 2016, or a trade Act No 40 of 2016 mark agent under the Trade Marks Act; “appropriate institution” has the meaning assigned to the words Cap. 401 in the Act; “certificate of registration” means a certificate of registration issued under regulation 8; “compulsory licence” means a licence issued under regulation 17; “counter-statement” means a response to an objection for the registration of traditional knowledge or expressions of folklore; “holder” has the meaning assigned to the word in the Act; “licensing agreement” means an agreement concluded by the holder of an expression of folklore to authorise or licence the use of the expression of folklore; and “Nagoya Protocol” means the Nagoya Protocol on Access and Benefit sharing which entered into force on 12th October, 2014 and was ratified by Zambia on 20th May, 2016. PART II Registration APPLICATION FOR REGISTRATION OF TRADITIONAL KNOWLEDGE OR of traditional knowledge EXPRESSIONS OF FOLKLORE or expressions

3. (1) A person who intends to register traditional knowledge of folklore or expressions of folklore shall apply to the Registrar in Form I set out in the First Schedule on payment of the fee set out in the Second Schedule. (2) The Registrar shall cause a notice of the application for registration of the traditional knowledge or expressions of folklore in Form II set out in the First Schedule to be published in the Gazette, newspaper of general circulation in the Republic or other media. 538 Statutory Instruments 14th May, 2021 Objection to 4. (1) A person may, within sixty days of the date of the application for publication of the notice of the application for traditional knowledge registration or expressions of folklore, lodge an objection with the Registrar in of traditional Form III set out in the First Schedule on payment of the fee set out knowledge or expressions in the Second Schedule. of folklore (2) The Registrar shall, within fourteen days of receipt of an objection made under subregulation (1), serve the applicant with a copy of the objection. (3) An applicant shall, within thirty days of receipt of the objection, lodge with the Registrar a counterstatement in Form IV set out in the First Schedule, stating the grounds relied on in support of the application for registration. (4) Where an applicant does not lodge the counterstatement under subregulation (3), the application shall be deemed to have been abandoned. Request for 5. (1) The Registrar may, where the Registrar requires further further particulars in relation to an application or an objection, request an particulars applicant or the person that lodged the objection to provide further particulars within sixty days, in Form V set out in the First Schedule. (2) A person who fails to provide further particulars as required under subregulation (1) shall be deemed to have abandoned that application or objection. Determination 6. (1) The Registrar shall, within sixty days of receipt of the of an counterstatement or further particulars, determine an objection and objection communicate the decision of the Registrar to the applicant and the person who lodged the objection. (2) Where the Registrar is of the opinion that an objection ought to be determined by an appropriate institution, the Registrar shall refer the objection to the appropriate institution and notify the parties accordingly. (3) The appropriate institution referred to in subregulation (2) shall determine the objection and communicate its decision to the Registrar within sixty days of receipt of the objection. (4) The Registrar shall communicate the final decision made under subregulation (3) to the applicant and the person who lodged the objection within fourteen days of receipt of the decision. Registration 7. The Registrar shall, within thirty days of the determination of traditional knowledge of an objection or within thirty days of the expiry of the period or within which to lodge an objection expressions of folklore 14th May, 2021 Statutory Instruments 539 (a) approve the application for registration of traditional knowledge or expressions of folklore, if the application meets the requirements of the Act; or (b) reject the application, if the application does not meet the requirements of the Act and notify the applicant in writing stating the reasons for the rejection.

8. (1) The Registrar shall, where the Registrar approves an Certificate application for the registration of traditional knowledge or of registration expressions of folklore, issue a certificate of registration in Form VI set out in the First Schedule. (2) The Registrar shall cause to be entered in the Register the particulars of the registered traditional knowledge or expressions of folklore as provided in the Act.

9. (1) A person who intends to access a registered traditional Access to knowledge or expressions of folklore shall apply to the holder for registered traditional prior informed consent on terms and conditions that the holder knowledge may determine. or expressions of folklore (2) Where the holder cannot be found, a person may apply for prior informed consent to the Registrar in Form VII set out in the First Schedule. (3) The Registrar may on receipt of an application under subregulation 2— (a) grant prior informed consent if the application meets the requirements under the Act; or (b) reject the application and notify the applicants in writing stating the reasons for the rejection. (4) The holder or Registrar may grant prior informed consent in Form VIII set out in the First Schedule. (5) Where prior informed consent is obtained from the holder, a user shall, on payment of the fee set out in the Second Schedule, submit the prior informed consent to the Registrar for approval in Form IX set out in the First Schedule. (6) The Registrar shall within thirty days of the receipt of an application under subregulation (4)— (a) approve the prior informed consent if it meets the requirements of the Act; or (b) reject the prior informed consent if it does not meet the requirements of the Act. 540 Statutory Instruments 14th May, 2021 (7) The Registrar shall, in considering whether the holder has given prior informed consent, take the following into consideration: (a) whether the holder had adequate knowledge of the value of the traditional knowledge or expressions folklore; (b) whether the holder had sufficient time to consider the application and make necessary consultations; and (c) whether the holder was able to engage in reasonable negotiations with the applicant on benefit sharing. Application 10. (1) A holder who intends to authorise or licence the for approval expressions of folklore may conclude a licensing agreement. of licensing agreement (2) The holder shall, on conclusion of the licensing agreement, apply to the Registrar for approval of the licensing agreement in Form IX set out in the First Schedule on payment of the fee set out in the Second Schedule. (3) The Registrar shall within thirty days of receipt of the application for approval, approve or reject the licensing agreement. (4) Where the Registrar rejects the application under subregulation (3), the Registrar shall inform the applicant in writing, stating the reasons for the rejection. PART III ACCESS TO GENETIC RESOURCES Application 11. (1) A person who intends to access genetic resources for prior informed shall apply to the holder, for prior informed consent on terms and consent conditions that the holder may determine. (2) Where the holder cannot be found, a person may apply for prior informed consent to the Registrar in Form VII set out in the First Schedule. (3) The Registrar shall, within thirty days of receipt of an application under subregulation (2)— (a) grant prior informed consent if the application meets the requirements under the Act; or (b) reject the application and notify the applicant in writing stating the reasons for the rejection. (4) The holder or the Registrar, may grant prior informed consent in Form VIII set out in the First Schedule. (5) Where prior informed consent is obtained from the holder, a user shall, on payment of the fee set out in the Second Schedule, submit the prior informed consent to the Registrar for approval in Form IX set out in the First Schedule. 14th May, 2021 Statutory Instruments 541 (6) The Registrar shall in considering whether the holder has given prior informed consent take the following into consideration: (a) whether the holder had adequate knowledge of the value of the resources being accessed; (b) whether the holder had sufficient time to consider the application and make necessary consultations; (c) whether the holder was able to engage in reasonable negotiations with the applicant on benefit sharing; and (d) where the genetic resource is communally owned, whether the views of the community were taken into account. (7) On approval of the prior informed consent, the Registrar shall cause the particulars of the prior informed consent contract to be entered in the Register.

12. (1) A person who intends to access genetic resources Access shall apply to the Registrar for an access permit in Form XIII set permit or exploration out in the First Schedule on the payment of the fee set out in the permit Second Schedule. (2) A person who intends to explore genetic resources shall apply to the Registrar for an exploration permit in Form XIII set out in the First Schedule on the payment of the fee set out in the Second Schedule. (3) Where the application for an access permit or exploration permit meets the requirements of the Act, the Registrar shall within fourteen days of receipt of the application, submit a copy of the application to the appropriate institution for recommendation. (4) The appropriate institution shall, within sixty days of receipt of the application for an access permit or exploration permit, communicate its recommendations, in writing, to the Registrar. (5) The Registrar shall, on receipt of the recommendation from the appropriate institution, approve or reject the application for an access permit or exploration permit. (6) Where the Registrar rejects the application under subregulation (5), the Registrar shall inform the applicant, in writing, stating the reasons for the rejection. (7) Where the Registrar approves an application for an access permit or exploration permit, the Registrar shall issue an access permit or exploration permit in Form XIV and Form XV set out in the First Schedule, respectively. 542 Statutory Instruments 14th May, 2021 (8) The Registrar shall cause to be entered in the Register the particulars of the access permit or exploration permit as provided in the Act. (9) An access permit or exploration permit issued under this regulation shall be valid for a period of two years and may thereafter be renewed annually on the payment of the fee set out in the Second Schedule. (10) An application for renewal of an access permit or exploration permit shall be in Form XVI set out in the First Schedule and shall be made at least three months before the expiry of the permit. (11) The Registrar may, in consultation with the appropriate institution and the holder, renew an access permit or exploration permit in Form XVII set out in the First Schedule. PART IV GENERAL PROVISIONS Access 13. (1) A person who intends to access traditional knowledge agreement or genetic resources shall sign an access agreement with the holder. (2) The holder and user may adopt the model access agreement set out in Form X in the First Schedule. (3) A user shall apply to the Registrar for approval of the access agreement in Form IX in the First Schedule on payment of the fee set out in the Second Schedule. (4) The Registrar shall, within fourteen days of receipt of the application under subregulation (3), cause the access agreement to be published in a newspaper of daily circulation in the Republic or other media. Objection to 14. (1) A person may, within thirty days from the date of the access agreement publication of the access agreement, lodge an objection with the Registrar in Form III set out in the First Schedule. (2) Regulations 4, 5 and 6 shall apply to an objection lodged under this regulation, with the necessary modifications. Approval or 15. (1) The Registrar shall, within thirty days of the final rejection of determination of the objection to an access agreement— access agreement (a) approve the access agreement if it meets the requirements of the Act; or (b) reject the access agreement if it does not meet the requirements of the Act. 14th May, 2021 Statutory Instruments 543 (2) On approval of the access agreement, the Registrar shall cause the particulars of the access agreement to be entered in the Register. (3) Where the Registrar rejects the access agreement, the Registrar shall notify the holder and the user of the rejection in writing stating the reasons for the rejection.

16. Where the Registrar alters, suspends or terminates an access agreement, the Registrar shall notify the holder and the user in writing.

17. (1) Where traditional knowledge or genetic resource that Alteration, is protected in accordance with the Act, is not being sufficiently suspension or exploited by the holder or where the holder refuses to grant access, termination a person may, on payment of the fees set out in the Second Schedule, of access agreement apply to the Minister for a compulsory licence in Form XI set out in the First Schedule. (2) Subject to subregulation (1), the Minister may grant a Compulsory compulsory licence in Form XII set out in the First Schedule. licence

18. (1) A person who intends to engage an agent for Appointment purposes of lodging any document under these Regulations with of agent the Agency shall apply to the Registrar for appointment of an agent in Form XVIII set out in the First Schedule on the payment of the fee set out in the Second Schedule. (2) Despite subregulation (1), a person that ordinarily does not reside in the Republic, shall lodge documents under subregulation (1) with the Agency through an agent.

19. A person may, on the payment of the fee set out in the Request for Second Schedule, request the Registrar in Form XIX for a copy of information from a document recorded in the Register or any other particulars from Register the Register.

20. (1) A person whose details are registered in the Register Notification or any other register maintained by the Agency shall notify the of change of particulars Registrar of any change in that person’s registered particulars. (2) A notification under subregulation (1) shall be in Form XX set out in the First Schedule. (3) The Registrar on receipt of the notification under subregulation (2), enter the changes in the Register.

21. A holder may apply to the Agency for a duplicate certificate Application of registration in Form XXI set out in the First Schedule on the for duplicate certificate payment of the fee set out in the Second Schedule. 544 Statutory Instruments 14th May, 2021 Application 22. A person may apply to the Agency for the amendment or for correction of a document lodged with the Registrar in Form XXII amendment set out in the First Schedule on the payment of the fee set out in the or correction of document Second Schedule. Competent 23. For purposes of the Nagoya Protocol— National Authority (a) the Agency shall be the Competent National Authority and National Focal Point responsible for— (i) grant of access permit under the Act; (ii) issuance of written evidence that access requirements have been met; and (iii) giving advice on applicable procedures and requirements for obtaining prior informed consent; and (b) the Ministry responsible for natural resources shall be the National Focal Point for purposes of providing information on— (i) procedures for obtaining prior informed consent and establishing mutually agreed terms for applicants seeking to access genetic resources or traditional knowledge associated with genetic resources; and (ii) appropriate institutions and relevant indigenous and local communities. Fees 24. The fees set out in the Second Schedule are payable for the matters specified therein. 14th May, 2021 Statutory Instruments 545

FIRST SCHEDULE (Regulations 3,4,5,7,8,9,10,13,14,15,16,19,20 and 21) FORM I (Regulation 3(1)) (To be completed in duplicate) THE PATENTS AND COMPANIES REGISTRATION AGENCY The Protection of Traditional Knowledge, Genetic Resources and Expressions of Folklore Act (Act No. 16 of 2016) The Protection of Traditional Knowledge, Genetic Resources and Expressions of Folklore Regulations, 2021 APPLICATION FOR REGISTRATION OF TRADITIONAL KNOWLEDGE OR EXPRESSIONS OF FOLKLORE TRADITIONAL KNOWLEDGE EXPRESSIONS OF FOLKLORE (Tick [√] where applicable) Shaded fields for Application No. Please write in BLOCK LETTERS official use only Date/Time TO THE REGISTRAR: Details of applicant (a) Full names (b) Nationality (c) Residential address (d) Identity number (e) Mobile number (f) Email address Details of holder (a) Full names (b) Nationality (c) Identity number (d) Email address (e) Mobile number (f) Physical address 1. Description of the traditional knowledge expressions of folklore and its associated economic, social scientific, technical, environmental or any other benefit that is likely to accrue to the traditional community or a holder. ……………………………………………………………………………………………………………………………… ……………………………………………………………………………………………………………………………… ……………………………………………………………………………………………………………………………… 546 Statutory Instruments 14th May, 2021 2. Use of the traditional knowledge expressions of folklore (in the traditional context) ……………………………………………………………………………………………………………………………… …………………………………………………………………………………………………………………………….. 3. I/we* ……………………………………………………………………………………………………………………. being the holder/representative do authorise/do not authorise* the Agency to grant prior informed consent in respect of the above stated traditional knowledge expressions of folklore 3. Date ………………………… ________________________ Signature of holder/representative *delete what is not applicable FOR OFFICAL USE Application received by ………………………………………… OFFICIAL Date received:…………………………………………………….. STAMP 14th May, 2021 Statutory Instruments 547 FORM II (Regulation 3(2)) (To be completed in duplicate) THE PATENTS AND COMPANIES REGISTRATION AGENCY The Protection of Traditional Knowledge, Genetic Resources and Expressions of Folklore Act (Act No. 16 of 2016) The Protection of Traditional Knowledge, Genetic Resources and Expressions of Folklore Regulations, 2021 NOTICE OF APPLICATION FOR REGISTRATION OF TRADITIONAL KNOWLEDGE OR EXPRESSIONS OF FOLKLORE Traditional knowledge Expressions of folklore NOTICE is given that an application for registration of the traditional knowledge/ expressions of folklore* has been filed with the Registrar. DETAILS OF APPLICATION 1. Type and economic value of traditional knowledge/expressions of folklore* …………… ………………………………………………………………………………………………………………. 2. Registration No. ………………………………………………………………………………………… 3. Name of applicant………………………………………………………………………………………. 4. Name of holder………………………………………………………………………………………….. 5. Location…………………………………………………………………………………………………… A person who has an objection to this registration shall lodge the objection, in writing, with the Registrar within sixty days of the date of publication of this notice. Dated this ……………………… day of ………………..20……………………….. _______________________ Registrar OFFICIAL STAMP 548 Statutory Instruments 14th May, 2021 FORM III (Regulation 4(1) and 14 (1)) (To be completed in duplicate) THE PATENTS AND COMPANIES REGISTRATION AGENCY The Protection of Traditional Knowledge, Genetic Resources and Expressions of Folklore Act (Act No. 16 of 2016) The Protection of Traditional Knowledge, Genetic Resources and Expressions of Folklore Regulations, 2021 NOTICE OF OBJECTION TO THE REGISTRAR: I/we*…………………...…………………………………………………………give notice of my/our* intention to object to: (a) the registration of traditional knowledge/expressions of folklore* (b) licensing/assignment* of traditional knowledge (c) licensing/assignment* of expressions of folklore (d) access agreement Here insert which appeared in the …………………………………………..............of the reference No. of the……..…day of ........................... 20..............., on page number ......................under registration/ licensing/ the ………………….. number……………………….. assignment/ access The grounds of objection are as follows: agreement (a) …………………………………………………………………………………….…….. (b) ………………………………………………………………………………….……….. (c) …………………………………………………………………………………….…….. Dated this …………….………. day of…………..………….. 20 ………..….…..….. __________________________________ Signature of the person objecting *delete what is not applicable FOR OFFICIAL USE ONLY Received by:____________________________________ Date received:__________________________________ OFFICIAL STAMP 14th May, 2021 Statutory Instruments 549 FORM IV (Regulation 4(3)) (To be completed in duplicate) Counter Statement No.:............ THE PATENTS AND COMPANIES REGISTRATION AGENCY The Protection of Traditional Knowledge, Genetic Resources and Expressions of Folklore Act (Act No. 16 of 2016) The Protection of Traditional Knowledge, Genetic Resources and Expressions of Folklore Regulations, 2021 COUNTER-STATEMENT TO AN OBJECTION TO: THE REGISTRAR Details of application or agreement number (1) Here IN THE MATTER of application for registration of traditional knowledge/ expressions of insert application folklore/access agreement/licensing agreement*(1) number or agreement number …………………………………………………………………………………….. Grounds in support of application I/we* ……………………………………………………………………………...…………………… the applicant(s) of the above traditional knowledge/ expressions of folklore/access (2) Here agreement/licensing agreement*(2) number……………………………………………..…… insert …………………………………………………………………………………………….., give notice grounds that the following are the grounds on which I/we* rely for my/our* application: relied on to ………………………………………………………………………………………………………… support application ….. (in case of additional …………………………………………………………………………….…………………………… information … attach extra sheets) ………………………………………………………………………..……………………..………… … ………………………………………………………..………………………………………… ………………………………………………………………………………………………….. Allegations admitted (3) Here I/we* admit the following allegations in the notice of objection(3): insert allegations ………………………………………………………………………………………………… admitted if … any ………………………………………………………………………………………………….. ………………………………………………………………………………………………….. Dated this ……………… day of ……….………………… 20…….. Dated this ……………… day of ……….………………… 20…….. (4) Here (4) ___________________ insert signature of Holder/representative* holder/repr esentative* * delete what is not applicable 550 Statutory Instruments 14th May, 2021 FORM V (Regulation 5(1)) (To be completed in duplicate) THE PATENTS AND COMPANIES REGISTRATION AGENCY The Protection of Traditional Knowledge, Genetic Resources and Expressions of Folklore Act (Act No. 16 of 2016) The Protection of Traditional Knowledge, Genetic Resources and Expressions of Folklore Regulations, 2021 REQUEST FOR FURTHER PARTICULARS (1)Here insert full 1. To: Full name (1)…………………………..…………………………………………… of names and ……………………………..……………………….………………………………..………………… address of holder/repres entative/obje ……………………………………………………………………………………………………………. ctor* (2) Here 2. IN THE MATTER of application for registration of traditional knowledge/ expressions of insert the application folklore/access agreement*(2) number…………………………………... number or …………………………………………………………………………………..…………………… number for the ………………………………………………………………………………………………………. agreement INFORMATION REQUESTED FOR (3) Here 3. You are requested to provide the following information: provide the requested information (1) ……………………………………..…………………………….………………………………… ……………………………………………………..………………………………………………… (2)……………………………………………………..………………………………………………… …………………………………….…………………………………………………………………….. (3)………………………………………………………………………………………………………… ……………………………………………………………………………………………………………. 4. The information requested in the paragraph (3) above should be provided within thirty days of the receipt of this request. In the event that the requested information is not provided within the stated period, you will deemed to have abandoned the objection to the application/agreement*. Received by:___________________________________________ Name and signature Date received: ________________________________________ FOR OFFICIAL USE ONLY Received by:___________________________________________ Officer’s name and signature Date received ________________________________________ OFFICIAL STAMP * delete what is not applicable 14th May, 2021 Statutory Instruments 551 FORM VI (Regulation 8(2)) (To be completed in duplicate) Certificate No.:......... THE PATENTS AND COMPANIES REGISTRATION AGENCY The Protection of Traditional Knowledge, Genetic Resources and Expressions of Folklore Act (Act No. 16 of 2016) The Protection of Traditional Knowledge, Genetic Resources and Expressions of Folklore Regulations, 2021 CERTIFICATE OF REGISTRATION FOR TRADITIONAL KNOWLEDGE/EXPRESSIONS OF FOLKLORE Name of traditional community/group/individual*: ………………………………….………..……… Address........................................................................................................................…… Description of the traditional knowledge/expressions of folklore* : ............................................................................................................................................ This is to certify that the traditional community/group/person* named on this Certificate has been registered as the holder of the traditional knowledge/expressions of folklore* described above. Given on this ……………………….. day of …………………………………… 20 ………………… __________________ Registrar OFFICIAL SEAL 552 Statutory Instruments 14th May, 2021 FORM VII (Regulation 9(2) and 11(2)) (To be completed in duplicate) Application No.:........... THE PATENTS AND COMPANIES REGISTRATION AGENCY The Protection of Traditional Knowledge, Genetic Resources and Expressions of Folklore Act (Act No. 16 of 2016) The Protection of Traditional Knowledge, Genetic Resources and Expressions of Folklore Regulations, 2021 APPLICATION FOR PRIOR INFORMED CONSENT Shaded fields for Application No. Please write in BLOCK LETTERS official use only Date/Time TO: AGENCY/HOLDER* DETAILS OF APPLICANT (a) Full names (b) Nationality (c) Identity number (d) Telephone number (e) Mobile number (f) Physical address (g) Email address I/we* apply for prior informed consent in respect of the following traditional knowledge/genetic resources/expression of folklore* ……………………………………………………………………………………… 1. Traditional knowledge/ genetic resources/expression of folklore* registration number (where applicable) …………………………………………………………………………………………………………………….. 2. The reasons for prior informed consent:………………………………………………………………………… ………………………………………………………………………………………………………………… 3. I/we* declare that I am/we are willing to enter into an agreement on mutually agreed terms. 4. I/we* declare further that to the best of my/our knowledge, the information given in this application is correct and true and that the prior informed consent will only be used for the reasons stated in this application. Dated this……………. day of ……………………… 20 ………………… _______________________ Signature of applicant 14th May, 2021 Statutory Instruments 553 FOR OFFICIAL USE ONLY Application received by: ……………………………………………… Date received:…………………………………………………………… OFFICIAL STAMP 554 Statutory Instruments 14th May, 2021 FORM VIII (Regulation 9(4) and 11(4)) (To be completed in duplicate) THE PATENTS AND COMPANIES REGISTRATION AGENCY The Protection of Traditional Knowledge, Genetic Resources and Expressions of Folklore Act (Act No. 16 of 2016) The Protection of Traditional Knowledge, Genetic Resources and Expressions of Folklore Regulations, 2021 PRIOR INFORMED CONSENT To Applicant: ……………………………………………………………………………………….….……… Address of Applicant…………………………………………………………………………………………... I/we*……………………………………………………………………………………………………………… being the holder/Agency* acting on behalf of the holder of the following traditional knowledge/genetic resources/expression of folklore*………………………………………………………………………………… ……………………………………………………………………………………………………………………… located at …………………………………………………………………………………….. consent that the above named applicant may access the above stated traditional knowledge/expression of folklore*/apply to the Agency for an access permit in respect of the above stated genetic resources/traditional knowledge associated with genetic resources*. This consent is valid from ……………… 20…………….to ………………20……………………… and is subject to the following conditions: (i) ……………………………………………………………………………………………………………. (ii) …………………………………………………………………………………………………………… (iii) …………………………………………………………………………………………………………… (iv) …………………………………………………………………………………………………………. (v) ……………………………………………………………………………………………………………. 14th May, 2021 Statutory Instruments 555 The applicant has obtained the following agreements: (i) ………………………………………………………………………………………………………. (ii) ………………………………………………………………………………………….……. (iii) ………………………………………………………………………………………………. Dated this …………………..……… day of ………………….20…………………………………. _____________________ Registrar/Holder Endorsements: ………………………………………………………………………………….. ………………………………………………………………….………………. ………………………………………………………………………………….. Dated this ……………………..day of ………………….20…………… OFFICIAL STAMP 556 Statutory Instruments 14th May, 2021 FORM IX (Regulation 9(5),10(2)11(5) and 13 (3)) (To be completed in duplicate) Application No:............... THE PATENTS AND COMPANIES REGISTRATION AGENCY The Protection of Traditional Knowledge, Genetic Resources and Expressions of Folklore Act (Act No. 16 of 2016) The Protection of Traditional Knowledge, Genetic Resources and Expressions of Folklore (General) Regulations, 2021 APPLICATION FOR APPROVAL OF PRIOR INFORMED CONSENT ACCESS AGREEMENT LICENSING AGREEMENT (Tick [√] where applicable) Shaded fields for Application No. Please write in BLOCK LETTERS official use only Date/Time TO: THE REGISTRAR DETAILS OF USER (1) Here insert Full names ……………………………………………………………….…………... full names of user Identity Number ............................................................................................................. Nationality……............................................................................................................... Telephone Number………………………………………………………………….. .. Mobile number………………………………………………………….…………....... Residential address………….............................................................................. ............ Email address……………………….…………..…………………………………… .. (2) Here insert IN THE MATTER of an application for the approval of the attached prior informed consent full names of user contract/access agreement/licensing agreement* between (3) Here insert full names (2)……………………………………………….……………………………………………..… of holder ………………………………………….………………… and (3) …………………………… …………………………………….……………………………………………………………… Instructions (a) applicant for approval of access agreement and prior informed consent to attach signed copy of prior informed consent; (b) applicant for approval of licensing agreement to attach signed copy of licensing agreement. 14th May, 2021 Statutory Instruments 557 FOR OFFICIAL USE ONLY Received by:___________________________________________ Officer’s name and signature Date received: ________________________________________ OFFICIAL STAMP 558 Statutory Instruments 14th May, 2021 FORM X (Regulation13 (2)) (To be completed in duplicate) THE PATENTS AND COMPANIES REGISTRATION AGENCY The Protection of Traditional Knowledge, Genetic Resources and Expressions of Folklore Act (Act No. 16 of 2016) The Protection of Traditional Knowledge, Genetic Resources and Expressions of Folklore Regulations, 2021 Model Access Agreement THIS AGREEMENT made the…………………….day of…………….Two thousand and……………………………………………………………………………………………….. BETWEEN …………………………..of …………………………….. (hereinafter referred to as “the holder”) of the one part and ………………………………………of…………….1 (hereinafter referred to as “the User”) of the other part. WHEREAS the holder of the traditional knowledge/genetic resource* described in the First Schedule is a traditional community/group/individual*. AND WHEREAS the holder confirms that the holder has been informed of the research/ exploitation* by the User and consents to provide access to the traditional knowledge/genetic resources* in situ or ex situ* necessary to carry out the research/exploitation* in accordance with the project described in the Second Schedule. AND WHEREAS this Agreement is intended to specify the terms for accessing traditional knowledge/genetic resources,* its utilisation in accordance with the prior informed consent, and for sharing the benefits resulting from the utilisation of traditional knowledge/genetic resources.* NOW THIS AGREEMENT WITNESSETH as follows: 1.0 INTERPRETATION 1.1 The words defined in the Act shall have the same meaning in this Agreement, unless otherwise defined in this clause. 1.2 In this Agreement, unless the context otherwise requires— “associated traditional knowledge” means any experimental or observational data, information and other findings on the composition, life conditions and functions of the accessed genetic resources. “commercialisation” means the use of the traditional knowledge/genetic resources/traditional knowledge associated with genetic resources* for the generation of any kind of actual or potential economic profit; 1 Indicate registered office if it is a company 14th May, 2021 Statutory Instruments 559 “product” means the result produced, obtained, extracted or derived from the traditional knowledge/genetic resources/traditional knowledge associated with genetic resources* through research or research and development activities, including data and information generated through analysis of the traditional knowledge/genetic resources/ traditional knowledge associated with genetic resources*; “utilisation for proprietary purposes” means research and development that aims at protecting the traditional knowledge/genetic resources/traditional knowledge associated with genetic resources*, including products and processes developed, by intellectual property rights, keeping the associated traditional knowledge secret, making the associated traditional knowledge accessible at minimal cost for dissemination or bringing the products and processes developed from the accessed genetic resources on the market; “utilisation for the public domain” means research and development that aims at making the genetic resources or associated traditional knowledge, including products and processes developed, available to the public at a minimal cost for dissemination, and without being protected by patent rights or further restricted by other intellectual property rights; “utilisation of traditional knowledge/genetic resources/traditional knowledge associated with genetic resources*” means research and development on the genetic or biochemical composition of the accessed traditional knowledge/genetic resources/traditional knowledge associated with genetic resources*, including through the application of biotechnology to make or modify products or processes for specific use. 2.0 ACCESS TO GENETIC RESOURCES 2.1 The User shall be entitled to collect samples as follows:2 2.2. The User shall within ……………………3 *after collection of the samples notify the holder/representative of the holder* the types of samples the User intends to utilise. The holder/representative of the holder* may, within ………… (3) after receiving the notice, raise an objection in which case the parties will have to agree on the types of samples allowed to be utilised. 2.3 The User shall bear all the costs incurred in accessing and preserving the traditional knowledge/genetic resources/traditional knowledge associated with g e n e t i c resources*. 3.0 UTILISATION OF THE TRADITIONAL KNOWLEDGE/GENETIC RESOURCES* 3.1 The User shall be entitled to utilise the accessed traditional knowledge/genetic resources/traditional knowledge associated with genetic resources* in accordance with clause 2.0. 560 Statutory Instruments 14th May, 2021 3.2 The accessed traditional knowledge/genetic resources/traditional knowledge associated with genetic resources* shall be for commercialisation/utilisation for proprietary purposes/ utilisation for public domain*. Specifications 4 3.3 Where the accessed traditional knowledge/genetic resources* is for commercialisation/utilisation for public domain* and after the conclusion of this Agreement, the User intends to utilise the accessed traditional knowledge/ genetic resources/traditional knowledge associated with genetic resources* for proprietary purposes, the User shall seek the consent of the Holder. 3.4 Where the User intends to change the utilisation of the accessed traditional knowledge/genetic resources/traditional knowledge associated with genetic resources from non-commercial to commercial the User shall obtain a new prior informed consent issued by the Holder or the Agency. In this case, the terms of the commercialisation shall be subject to a separate benefit sharing agreement between the parties. 4.0 TRANSFER OF GENETIC RESOURCES TO THIRD PARTIES 4.1 A User may transfer the genetic resources and their associated traditional knowledge to third parties after having obtained the written consent of the Holder and in accordance with mutually agreed terms between the Holder and the third party unless where a transfer is for purposes of scientific identification by a taxonomic specialist. 4.2 Despite clause 4.1, the User shall be entitled to deposit the genetic resources in collections that are accessible without restrictions for research purposes such as herbaria, museums and culture collections. 4.3 Where the User transfers the collection of living genetic resources, for educational purposes, to a site outside their natural habitat or ecosystem, the User shall take appropriate precautions to prevent an unauthorised person from being in possession of the genetic resources. 4.4 The User shall maintain retrievable records of any transfer of the genetic resources to third parties under the conditions corresponding to this Agreement and allow access to such records to the holder or the authority designated by the Agency. ……………………………… (insert name and address of authority if applicable) 5.0 SCIENTIFIC COLLABORATION AND CAPACITY-BUILDING The User agrees to collaborate with scientists from within Zambia in the utilisation activities based on this Agreement. The collaboration shall be as follows: 5 …………………………………………………. 2 indicate the type of samples, quantity of samples and location of collection 3 period to be specified by the Parties 4 Specify the details of the intended utilisation of the accessed traditional knowledge/genetic resources/traditional knowledge associated with genetic resources 5 Here specify the details of the collaboration 14th May, 2021 Statutory Instruments 561 6.0 BENEFIT-SHARING IN CASE OF UTILISATION FOR PROPRIETARY PURPOSES 6.1 The benefits arising from the access and use of the genetic resources shall be shared fairly and equitably by the User, in accordance with the principles established in the Act. Basic benefits to be shared include— (a) an offer to the Holder to include local researchers in the research activities, where necessary; (b) in case of publications or oral presentation of the research results, acknowledgement is to be given to the source of the genetic resource/traditional knowledge*; (c) if traditional knowledge associated to the genetic resources is used in the research, results published or presented orally will include full acknowledgement of the source of the genetic resources and the traditional knowledge, if so required by the Holder; (a) the Holder will receive a copy of all publications; (b) research results will be communicated to involved stakeholders in an adequate manner and according to reasonable requirements of the Holder; (c) if applicable the User should share the duplicate specimens with the repository in Zambia in accordance with good scientific practice. In addition the parties agree as follows: 6.2 The User agrees to pay an up-front compensation of … (amount to be specified) to the Holder, if the User utilises the accessed genetic resources for proprietary purposes. The payment is due to the Holder within ………. months (term to be specified) after consent on the kinds of genetic resources to be utilised has been reached under clause 2.0. The payment shall be transferred to the following account of the holder/representative of the holder*: 6 ……………………………………… 6.3 Where the User utilises the accessed genetic resources or uses the associated Knowledge for proprietary purposes according to clause 3.3 and 3.4, it must fairly and equitably share with the Holder any monetary benefit obtained. 6.4 The share shall be determined by further negotiations between the Parties to this agreement. 6.5 (Alternative to 6.4) The share shall be ………………………percent of the revenue from sales of the product or process based on the accessed genetic resources. It shall be paid on the basis of a financial report to be sent to the holder or an authority designated by the Agency at the end of any year of any revenue generation to the account designated by the same. ____________________________________ 6 This clause is to be crossed out if not applicable 562 Statutory Instruments 14th May, 2021 (Insert authority and account details if applicable) 6.6 If the User utilises the accessed genetic resources or utilises the associated traditional knowledge for proprietary purposes without being entitled according to clause 3.3 or 3.4 and therefore in breach of the conditions of this agreement it must share with the Holder any monetary benefit obtained from such utilization or use. The share shall be …………………. percent of the revenue from sales of the product or process based on the accessed genetic resources. It shall be paid on the basis of a financial report to be sent to the Holder or an authority designated by the Agency in due time upon request by the same.7 __________________________________________________________________ (Insert authority and account details if applicable) 7.0 RESPECT FOR OTHER LAWS The User shall ensure that the collection, storage, transfer, utilisation and exportation of the genetic resources complies with all applicable laws of the republic of Zambia on the protection of human health and the environment, on taxes, on customs and any other concern. 8.0 DURATION OF THE AGREEMENT The Agreement shall be for a duration of ……………………commencing from to 8.0 APPLICABLE LAW The applicable law on any matters relating to the interpretation and the application of the present Agreement shall be: …………………….. 9.0 DISPUTE SETTLEMENT 9.1 No Party shall, in the event of a dispute arising from this agreement, commence court proceedings (except proceedings for urgent interlocutory relief) before searching for an amicable solution according to paragraphs 9.2 and 9.3 of this clause 9.2 A Party to this Agreement claiming that a dispute has arisen under or in relation to this agreement must serve the other Party with a written notice specifying the nature of the dispute on receipt of which the dispute resolution shall forthwith begin. 9.3 Any dispute arising from this Agreement shall be resolved expeditiously foremost by negotiation in good faith failure to which the Parties shall engage informal dispute resolution techniques, such as mediation and arbitration or similar techniques agreed to by them. 7 This article or single paragraphs of it are to be crossed out if not applicable 14th May, 2021 Statutory Instruments 563 10. TERMINATION OF THE AGREEMENT 10.1 The agreement may be terminated at any time by mutual agreement in writing. 10.2 The agreement may be terminated by default if the User fails to satisfy any of the obligations under this agreement. 10.3 In the case of default by the User, the Holder may immediately terminate this agreement by giving written notice to the User of the termination, provided that: (a) the holder has given prior notice to the User of the alleged default; and (b) the user fails to respond to the holder within the period specified by the notice (being not less than 20 business days and not more than 60 business days) to rectify or explain to the satisfaction of the holder the reasons for the default. 11.0 RESPONSIBLE PERSON The holder designates the following institution [insert the relevant institution] as the responsible contact point for the entire duration of the present Agreement. Contact details of the technical contact point are follows: ........................................................................................................................................ ............................................................................................................................... 12.0 INTELLECTUAL PROPERTY RIGHTS 12.1. The User shall not claim any intellectual property rights over the Traditional Knowledge/Genetic Resource* in the form received. If the User wants to obtain intellectual property rights on research results such act shall be treated as change in utilisation and thus shall be regulated under clause 3.5 of this Agreement. In particular the ownership of the IPR and the distribution of the value derived from the IPR are to be negotiated. 13.0 DATA SHARING 13.1 The User agrees that the Provider has the right to access the following data resulting from the research/utilisation ………………………………………………………........................................ ................................................[insert type of data] 13.2 The User shall facilitate access to the above defined data for the holder. 564 Statutory Instruments 14th May, 2021 AS WITNESS the hands of the parties hereto or their duly authorised agents the day and year first before written. SIGNED by Holder ) in the presence of: ) WITNESS Name: Address: Occupation: SIGNED by User ) in the presence of: ) WITNESS Name: Address: Occupation:(Footnotes) 14th May, 2021 Statutory Instruments 565 FORM XI (Regulation 17 (1)) (To be completed in duplicate) THE PATENTS AND COMPANIES REGISTRATION AGENCY The Protection of Traditional Knowledge, Genetic Resources and Expressions of Folklore Act (Act No. 16 of 2016) The Protection of Traditional Knowledge, Genetic Resources and Expressions of Folklore Regulations, 2021 567 Statutory Instruments 14th May, 2021 14th May, 2021 Statutory Instruments 568 FORM XII (Regulation 17 (2)) (To be completed in duplicate) Compulsory Licence No.:....... THE PATENTS AND COMPANIES REGISTRATION AGENCY The Protection of Traditional Knowledge, Genetic Resources and Expressions of Folklore Act (Act No. 16 of 2016) The Protection of Traditional Knowledge, Genetic Resources and Expressions of Folklore Regulations, 2021 COMPULSORY LICENCE FOR TRADITIONAL KNOWLEDGE GENETIC RESOURCES* (Tick [√] where applicable) Issued by: The Minister responsible for commerce (1) Here insert the To (1):………………………………………………………………………………………..… name of the applicant (2) Here insert the full of (2) ……….………………………………………………………………………….………. physical address of …………….…………………………………………………………………………………… the applicant WHEREAS the applicant in application No. ……….… applied for access to the following (3) Here describe the traditional knowledge/genetic resources*: (3) traditional knowledge/genetic …………………………………………………………………………………………………. resources applied for …………………………………………………………………………………………………… …………………………………………………………………………………………………… …………………………………………………………………………………………………… …………………………………………………………………………………………………… ………………………………………………………………………………………………….. ……………………………………………………………………………….………………….. held by (4)……………………………………………………………………………………… (4) Here insert name of holder ………………………………………………………………………………………………….. WHEREAS the traditional knowledge/genetic resource* described in paragraph (3) is not being sufficiently exploited by the holder or where the holder refuses to grant access subject to reasonable commercial terms and conditions. WHEREAS the applicant desires the right to access the said traditional knowledge/genetic resources* as follows: (5)………………………………………………………………………………………………… (5) Here insert the intended use of the …………………………………………………………………………………………………… genetic resource/traditional …………………………………………………………………………………………………… knowledge* …………………………………………………………………………………………………… …………………………………………………………………………………………………… WHEREAS in the interest of public security/public health*, I grant this compulsory licence on the following conditions: 569 Statutory Instruments 14th May, 2021 1. The applicant has the right to make use of the accessed traditional knowledge/genetic resource* as specified in the compulsory license. 2. In consideration of the compulsory licence, the applicant shall pay the holder a sum of (6) …………………………………………………………………………. 3. This compulsory licence is binding on – (6) Here insert the amount to be paid by (a) the holder and applicant; or the applicant as set by the Minister (b) in the case of traditional knowledge held by an individual, the heirs, legal representatives, successors, and an assignee of the individual holder. 4. In the case of genetic resources, the quantity to be accessed by the applicant is (7) ………………………………………………………………………… 5. This compulsory licence is valid for a period of …..……………………………… (7) Here indicate the quantities to be accessed by the Dated this .................. day of ……………………, 20............. applicant _____________________ Minister 1 Here specify the details of the collaboration 14th May, 2021 Statutory Instruments 570 FORM XIII (Regulation 12 (1) and (2)) (To be completed in duplicate) Application No....... THE PATENTS AND COMPANIES REGISTRATION AGENCY The Protection of Traditional Knowledge, Genetic Resources and Expressions of Folklore Act (Act No. 16 of 2016) The Protection of Traditional Knowledge, Genetic Resources and Expressions of Folklore Regulations, 2021 APPLICATION FOR ACCESS PERMIT OR EXPLORATION PERMIT ACCESS PERMIT EXPLORATION PERMIT (Tick [√] where applicable) Shaded fields for Application No. Please write in BLOCK LETTERS official use only Date/Time TO THE REGISTRAR: PART A ACCESS PERMIT Details of applicant (a) Full names (b) Nationality (c) Residential address (d) Identity number (e) Mobile number (f) Email address Details of traditional knowledge/genetic resources* (1) Here insert a brief 2. This application is for an access permit to access the following traditional description of the traditional knowledge/genetic resources*: (1) ...…………………………………................................. knowledge/ ………………………………………………………………………………………………… genetic resources* to be accessed ………………………………………………………………………………………………… ………………………………………………………………………………………………… ………………………………………………………………………………………………… Accompanying documents Documents accompanying the application – (a) a written prior informed consent (b) an access agreement (c) an Environmental Impact Assessment Report (where applicable) (d) a detailed project proposal Officer to tick documents received 571 Statutory Instruments 14th May, 2021 PART B EXPLORATION PERMIT Details pertaining to the Genetic Resources (1) Here insert a brief The applicant applies for an exploration permit to explore the following genetic resources: description of the genetic resources (1) ...................……………………………………….. to be explored ………………………………………………………………………………………………… ………………………………………………………………………………………………… (2) Here insert a clear ………………………………………………………………………………………………… description of the physical location of the genetic The location of the genetic resource listed in paragraph (1) is resources (2)……………………………………………………………………………………………… (3) Here indicate the full duration of the …………….…………………………………………………………………………………… exploration and ……………………..………………………………………………………………………… attach the time schedule for the exploration The estimated duration for the exploration is (3)……………………………………………………………………………………………… ………………………………………………………………………………………………… Purpose for the Exploration Permit The exploration permit is required for the following purposes: (a)………………………………………………………………………………………… …………………………………………………………………………………………… (b)………………………………………………………………………………………… (c)………………………………………………………………………………………… ………………………………………………………………………………………… (d)………………………………………………………………………………………… Attachments Please attach the Access agreement Dated this ……………… day of ……….………………… 20………. ______________________ Signature of applicant DECLARATION I/we* the applicant declare that the information provided herein and the accompanying documents are true and correct to the best of my/our* knowledge. I/we* declare further that to the best of my/our* knowledge, I/we* have complied with the relevant laws and regulations as per the documents. Dated this ………..………day of …..…….……… 20…….. _______________________ Signature of Applicant FOR OFFICIAL USE ONLY Received by:__________________________________________ Officer’s name and signature OFFICIAL Date received:________________________________________ STAMP * delete what is not applicable 14th May, 2021 Statutory Instruments 572 FORM XIV (Regulation 12 (7)) (To be completed in duplicate) THE PATENTS AND COMPANIES REGISTRATION AGENCY The Protection of Traditional Knowledge, Genetic Resources and Expressions of Folklore Act (Act No. 16 of 2016) The Protection of Traditional Knowledge, Genetic Resources and Expressions of Folklore Regulations, 2021 ACCESS PERMIT Shaded fields for Permit No. Please write in BLOCK LETTERS official use only Date/place of issue Details of applicant Full names Identity Number Nationality Residential address Telephone number Mobile number Email address 1. Subject to any other written law or agreement concluded between the holder and applicant, the above named applicant is authorised to access the following genetic resources located at………………………………………………………………….………………………………………………….…… (a) ……………………………………………………………… (b) ……………………………………………….……………. (c) ……………………………………………………………… 2. This permit is valid from ……………………….. 20……… to ………………………..20……… __________________________ Registrar OFFICIAL STAMP 573 Statutory Instruments 14th May, 2021 FORM XV (Regulation 12 (7)) (To be completed in duplicate) THE PATENTS AND COMPANIES REGISTRATION AGENCY The Protection of Traditional Knowledge, Genetic Resources and Expressions of Folklore Act (Act No. 16 of 2016) The Protection of Traditional Knowledge, Genetic Resources and Expressions of Folklore Regulations, 2021 EXPLORATION PERMIT Shaded fields for Permit No. Please write in BLOCK LETTERS official use only Date/place of issue Details of User Full names Identity Number Nationality Residential address Telephone number Mobile number Email address Details of Genetic Resources 2. Subject to any other written law and any other agreement concluded between the holder and applicant, the above named user is authorised to explore the following genetic resources located at ………………………………………………: (a) ………………………………………………………………………………… (b) ……………………………………………………………………………………………… (c) ……………………………………………………………………………………………… Purpose of Exploration Permit 3. The exploration permit is issued for the following purposes: (a)…………………………………………………………………………………………… …………………………………………………………………………………………… (b)…………………………………………………………………………………………… …………………………………………………………………………………………… (c)…………………………………………………………………………………………… ……………………………………………………………………………………………. 14th May, 2021 Statutory Instruments 574 (d)……………………………………………………………………………………….…… …………………………………………………………………………………………....... This permit is valid from ……………..20……………..to………………20………… The exploration permit holder is required to – (a) deposit a copy of the exploration permit with the relevant appropriate institution in the district where the exploration is to be undertaken; (b) strictly observe the terms and conditions specified in the exploration permit; (c) present, on completion of the exploration, to the Agency, or an appropriate institution designated by the Agency, a detailed report and plan of the exploration undertaken; (d) show, on request by an appropriate institution or person having an interest in the property in which the exploration is being undertaken, the exploration permit; (e) respect local customs, traditions, values and property rights in the locality where the exploration is being undertaken; and (f) observe and comply with the other relevant laws. 1. This permit may be withdrawn by the Agency should the holder breach any of the laws of the Republic of 1. This permit may be withdrawn by the Agency should the holder breach any of the laws of the Republic of Zambia or any of the conditions contained in the Access Agreements. 2. This permit is not transferrable. Dated this …………………… … day of …………..……… 20........... ___________________ Registrar 575 Statutory Instruments 14th May, 2021 FORM XVI (Regulation 12 (10)) Application No.:....... THE PATENTS AND COMPANIES REGISTRATION AGENCY The Protection of Traditional Knowledge, Genetic Resources and Expressions of Folklore Act (Act No. 16 of 2016) The Protection of Traditional Knowledge, Genetic Resources and Expressions of Folklore Regulations, 2021 APPLICATION FOR RENEWAL OF ACCESS PERMIT OR EXPLORATION PERMIT ACCESS PERMIT EXPLORATION PERMIT (Tick [√] where applicable) Shaded fields for Application No. Please write in BLOCK LETTERS official use only Date/Time TO THE REGISTRAR: Details of Permit Holder Full names ………………………………………….………………….…………………….. Identity Number ............................................................................................. Nationality……................................................................................................ Residential address…………………................................................................... Telephone Number………………………………………………………………………….. Mobile number…………………………………….…………………………………………. Email address………………………………………………………………………………… 1. Here insert the date The access/exploration* permit holder applies for the renewal of the access/exploration* of expiry of the Access/ permit which is due to expire on (1)……………….day Exploration* permit of……………………………….20……………… Accompanying documents 2. Here describe full 1. The following documents are attached to this application: details and conditions of (a) current permit Access/Exploration* Permit and any other (b) written prior informed consent* accompanying documents (c) an access agreement* (d) an Environmental Impact Assessment Report* (where applicable) (e) a detailed project proposal where there is a new project or the project has changed* Dated this ……………… day of ……….………………… 20……… _________________________ Signature of applicant 14th May, 2021 Statutory Instruments 576 DECLARATION I, the applicant declare that the information provided herein and the accompanying documents are true and correct to the best of my knowledge. Officer to tick box where relevant document attached. Received by:___________________________________________ Officer’s name and signature Date received: ________________________________________ OFFICIAL STAMP 577 Statutory Instruments 14th May, 2021 FORM XVII (Regulation 12 (11)) Application No.:....... THE PATENTS AND COMPANIES REGISTRATION AGENCY The Protection of Traditional Knowledge, Genetic Resources and Expressions of Folklore Act (Act No. 16 of 2016) The Protection of Traditional Knowledge, Genetic Resources and Expressions of Folklore Regulations, 2021 RENEWAL OF ACCESS PERMIT OR EXPLORATION PERMIT ACCESS PERMIT EXPLORATION PERMIT (Tick [√] where applicable) Shaded fields for Application No. Please write in BLOCK LETTERS official use only Date/Time Details of Permit Holder Full names ………………………………………….………………….…………………….. Identity Number ....................................................................................................................... Nationality……........................................................................................................................ Residential address…………………...................................................................................... Telephone Number………………………………………………………………………….. Mobile number…………………………………….…………………………………………. Email address………………………………………………………………………………… This renewal is effective from …………………….to …………………………….. Date this …………………………. day of ………………… 20 ………… OFFICIAL STAMP 14th May, 2021 Statutory Instruments 578 FORM XVIII (Regulation 18(1)) Application No.:....... THE PATENTS AND COMPANIES REGISTRATION AGENCY The Protection of Traditional Knowledge, Genetic Resources and Expressions of Folklore Act (Act No. 16 of 2016) The Protection of Traditional Knowledge, Genetic Resources and Expressions of Folklore Regulations, 2021 APPOINTMENT OF AGENT TO: THE REGISTRAR DETAILS OF APPLICANT (1) Here also Full names (1)……………………………………………………….……….…………………….. indicate if user or Identity Number ........................................................................................................................ holder Nationality…….......................................................................................................................... Residential address…………...................................................................................................... Telephone Number……………………………………….…………………………………….….. Mobile number………………………………………..……………………………………………. Email address…………………………………….………………………………………………… DETAILS OF AGENT Full names ……………………………………………………………...…….…………………….. Identity number ................................................................................................................................. Nationality…….................................................................................................................................. Residential address………………..………....................................................................................... Telephone number………………………………………………..…………………………….….. Mobile number…………….……………………………..…………………………………………. Email address…………………………………………..…………………………………………… I/we* ……………………………………….………………………………………………………… ……………………………………………………………..… authorise the above named person/firm*to act as my/our* agent in respect of (2)…………………………………………………………………………………………….. …………………………………………………………………………………………………. and (2)Here indicate the request that all notices, requisitions and communications relating thereto may be sent to the agent at relevant subject the above address. matter I/we* further revoke all previous authorisation/appointment, if any, in respect of the subject matter. 579 Statutory Instruments 14th May, 2021 Dated this ………………….. day of ……….……….……………..………, 20………… ___________________ Signature of applicant FOR OFFICIAL USE ONLY Received by:___________________________________________ Officer’s name and signature Date received: ________________________________________ OFFICIAL STAMP *delete what is not applicable 14th May, 2021 Statutory Instruments 580 FORM XIX (Regulation 19) Notice No.:....... THE PATENTS AND COMPANIES REGISTRATION AGENCY The Protection of Traditional Knowledge, Genetic Resources and Expressions of Folklore Act (Act No. 16 of 2016) The Protection of Traditional Knowledge, Genetic Resources and Expressions of Folklore Regulations, 2021 REQUEST FOR INFORMATION TO: THE REGISTRAR DETAILS OF APPLICANT Full names (1)……………………………………………………….……….…………………….. Identity Number ......................................................................................................................... Nationality…….......................................................................................................................... Residential address…………...................................................................................................... Telephone Number……………………………………….…………………………………….….. Mobile number………………………………………..……………………………………………. Email address…………………………………….………………………………………………… (1) Here I/we*(1) insert name of ………………………………………………………………………………………………………... holder/re presentat ………………………………………………………………………………………………………… ive* (2) Here specify in my/our* capacity as (2) ……………………………………………………………….. give notice whether holder/re of the changes) in the particulars entered in the Register (3) …………………………………........... p- resentati ve* ………………………………………………………………………………………………………… (3) Here specify …………………………………………………………………… register* as follows: name of register ……………………………….………………………………………………………………………… ………………………………………………………………………..………………………………… ………………………………………………………………………..………………………………… ……………………………………………………………………..…………………………………… …………………………………………………………………..……………………………………… ………………………………………………………………………………………………………… ………………………………………………………………………………………………………… 581 Statutory Instruments 14th May, 2021 Dated this ……………… day of ……….………………… 20……. _____________________ Signature of Holder/Representative* FOR OFFICIAL USE ONLY Received by:___________________________________________ Officer’s name and signature Date received: ________________________________________ OFFICIAL STAMP 14th May, 2021 Statutory Instruments 582 FORM XX (Regulation 20(2)) Notice No.:....... THE PATENTS AND COMPANIES REGISTRATION AGENCY The Protection of Traditional Knowledge, Genetic Resources and Expressions of Folklore Act (Act No. 16 of 2016) The Protection of Traditional Knowledge, Genetic Resources and Expressions of Folklore Regulations, 2021 NOTICE OF CHANGE OF PARTICULARS TO: REGISTRAR Details of applicant (1) Here I/we*(1) insert name …………………………………………………………………………………..…………………....... of holder/ representati ve* in my/our* capacity as (2) ……………………………………………………………………... give (2) Here notice of the change(s) in the particulars entered in the Register (3) …………………..……............... specify whether ……………………………………………………………………………………… register* as holder/repr follows: esentative* (3) Here ……………………………….………………………………………………………………………… specify name of ………………………………………………………………………..………………………………… register ………………………………………………………………………..………………………………… ……………………………………………………………………..…………………………………… …………………………………………………………………..……………………………………… ………………………………………………………………………………………………………… Dated this ……………… day of ……….………………… 20……. ______________ Signature of Holder/Representative* FOR OFFICIAL USE ONLY Received by:___________________________________________ Officer’s name and signature Date received: ________________________________________ OFFICIAL STAMP * delete what is not applicable 583 Statutory Instruments 14th May, 2021 FORM XXI (Regulation 21) Application No.:....... THE PATENTS AND COMPANIES REGISTRATION AGENCY The Protection of Traditional Knowledge, Genetic Resources and Expressions of Folklore Act (Act No. 16 of 2016) The Protection of Traditional Knowledge, Genetic Resources and Expressions of Folklore Regulations, 2021 APPLICATION FOR DUPLICATE CERTIFICATE FOR TRADITIONAL KNOWLEDGE OR EXPRESSIONS OF FOLKLORE* TRADITIONAL KNOWLEDGE EXPRESSIONS OF FOLKLORE (Tick [√] where applicable) Shaded fields for Application No. Please write in BLOCK LETTERS official use only Date/Time TO: THE REGISTRAR DETAILS OF APPLICANT Full names ……………………………………………………………………….…………………….. Identity Number ........................................................................................................ Nationality……........................................................................................................... Residential address…………........................................................................................ Telephone Number……………………………………...…………………………………………….. Mobile number…………………………………………………………………………………………. Email address……………………………………………...…………………………………………… (1) Here I/we*(1) …………………………………………………………….…………………………………… insert name of holder/ representative ……………………………………………………………………………………….…………………….. * (2)Here in my/our* capacity as (2) ……………………………………………………………….. request for a specify duplicate of the certificate of registration for traditional knowledge/expressions of folklore* whether holder/repres number………………………………………..………. for the following reasons: entative* …………………………………………………………………..……………………………………….. ………………………………………………….………………………………………………… …………………………………………………………………………………………………… FOR OFFICIAL USE ONLY Received by:___________________________________________ Officer’s name and signature Date received: ________________________________________ OFFICIAL STAMP 14th May, 2021 Statutory Instruments 584 FORM XXII (Regulation 21) Application No.:....... THE PATENTS AND COMPANIES REGISTRATION AGENCY The Protection of Traditional Knowledge, Genetic Resources and Expressions of Folklore Act (Act No. 16 of 2016) The Protection of Traditional Knowledge, Genetic Resources and Expressions of Folklore Regulations, 2021 APPLICATION FOR AMENDMENT OF DOCUMENT LODGED TO: THE REGISTRAR: Details of applicant (a) Full name (b) Identity number (c) Nationality (d) Residential address (e) Telephone number (f) Mobile phone number (g) Email address Details of agent (if filed by agent) (a) Full name (b) Identity number (c) Nationality (d) Residential address (e) Telephone number (f) Mobile number: (g) Email address: The Registrar is requested by the above named applicant to amend the document stated below – …………………………………………………………………………………………………………………………….. The following are the details to be amended: (i) ……………………………………………………………………………………………………………….. (ii) ……………………………………………………………………………………………………………….. (iii) ……………………………………………………………………………………………………………….. (iv) ……………………………………………………………………………………………………………….. 585 Statutory Instruments 14th May, 2021 Dated this ………………………… day of ………………………….…………….20……………………. __________________________ Signature of applicant/holder FOR OFFICIAL USE ONLY: Application received by: ______________________________________ Officer’s name and signature Date received: _____________________________________ OFFICIAL STAMP 14th May, 2021 Statutory Instruments 586

SECOND SCHEDULE (Regulation 24) PRESCRIBED FEES No. Item Form No. Foreign ZMW fee TRADITIONAL KNOWLEDGE 1 Application for registration of Traditional I N/A 500 Knowledge 2 Notice of application for registration of II N/A 500 Traditional Knowledge, GENETIC RESOURCES 3 Application for access permit XIII 5,000 1,000 4 Application for an exploration permit XIII 3,000 1,000 5 Application for renewal of access permit XVI 5,000 1,000 6 Application for renewal of exploration permit XVI 3,000 1,000 EXPRESSIONS OF FOLKLORE 7 Application for registration of Expressions I N/A 300 of Folklore 8 Notice of application for registration of II N/A 500 Expressions of Folklore, GENERAL PROVISIONS 9 Appointment of Agent XVIII 1,000 500 10 Application for prior informed consent VII 5,000 500 11 Application for approval of Prior Informed IX 1,000 100 Consent/Access/Licensing agreement 12 Notice of Objection III 2,500 1,000 13 Application for a Compulsory Licence XI 5,000 2,500 14 Request for information XIX 350 100 15 Application for duplicate certificate for XXI 500 500 traditional knowledge/ expressions of folklore 16 Application for amendment/correction of XXII 500 500 clerical errors C. YALUMA, Minister of Commerce, Trade and Industry LUSAKA 11th May, 2021 [MCTI.101/21/2]