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Laws of Kenya

Environmental Management and Co-ordination (Access to Biological Resources and Benefit Sharing) (No. 2) Regulations, Legal Notice no. 68 of 2025

Made 2025-03-24 · Text as of 2026-10-01

Public law and official guidance, published as research. Not legal, tax or financial advice.

About this law

Language
English
Kind
Regulation
Country
Kenya
Subjects
Environment, Cultivated plants, Wild species and ecosystems
Keywords
environmental impact assessment (EIA), genetic resources, PIC-prior informed consent, sustainable use, inventory, breeders' rights, contracts, offences/penalties, plant variety, intellectual property rights, authorization/permit, access and benefit-sharing, endangered species, protection of habitats, biodiversity, community management, traditional knowledge/indigenous knowledge, access right, protection of species, survey/mapping, ecosystem conservation
Categories
agriculture

Where to read it

Text

The law's own text, section by section, as held. Each section has its own link.

  1. nat ional COUNCIL FOR l aw REPORTING l i b r a r y f 76 1'SPE C I A L I SSU E 24th‘Mar ch, 2025Kenya Gazette Supplement No. 47 (Legislative Supplement No. 29) L eg a l N o t i c e N o . 6 8 TH E EN V m ON M EN T A L M A N A GEM ENT A N D CO O RD I N A T I O N A C T (Cap . 387j T H E EN V I R ON M EN T A L M A N A GEM ENT A N D CO ORDINATION (ACCESS TO BIOLOGICAL RESOURCES AND BENEFIT SHARING) (NO. 2) REGUL ATIONS, 2025 A R R A N G E M E N T O F R E G U L A T I O N S Regulation. PA R T I - PRE L EvON A R Y PR OV I SI ON S 1 — C i tat i on . 2—Interpretation. 3—Obj ectives. 4—AppUcatibn. 5—Competent National Authority. PA R T n - CON SERV A T I ON OF B I OL OG I CA L D IV E RSIT Y 6—Environmental impact assessment li cence. 7—Conservation of threatened species. 8—Inventory of biological diversity . 9—Indigenous and local communi ty biodiversity measures. 10—M onitoring. PA R T m - A CCESS T O B I OL OG I CA L RE SOU R CES 11 — Application for access permit (non-commercial an d comm erci al ) . 12—Prior informed consent and mutuall y-agreed terms. 13—Publication of application for access permits' 14—Determination of an access permit . 15—Grant or ref usal to grant access permit . 16 — C o m m u ni c at io n o f d ec i si o n . 17—Validity and non-transferabil ity of access permits. \ 762 Kenya Subsidiary Legislat ion, 2025 18—Terms and conditi ons of access permits. 19—Suspension, cancellati on and revocati on of access permits. 20—Register of access permits. PA RT IV - M A TERI A L TRA N SFER A GRE EM E NT S 21—M aterial transfer agreements. PA R T V - B E N E F TT SH A R I N G 22—Appli cati on of Part . 23—Benefi t sharing. PA R T V I - M I SCEL L A N E O U S PR OV I SI ON S 24—Confi denti ali ty . 25 — T r an si ti o n . 26—Dispute resoluti on. 2 7 — O f fen ce s . 2 8 — P en al ti es . 2 9 — R ev o cati on . SC H E D U L E S FIRST SCHEDULE - Application for Access Permit SECOND SCHEDULE - Fees per local ity T H I R D SC H E D U L E - A cc ess P erm i t FOURTH SCHEDULE - Prior Informed Consent (PIC) FI FTH SCHEDUL E - M utuall y Agreed Terms SIXTH SCHEDUL E - Material Transfer Agreement NATIONAL COUNCIL FOR . LAW REPORTING 1 U PR 2025 L I B R A R Y A R C H I V E 7 63Kenya Subsidiary Legislation, 2025 TH E EN V I R ON M ENT A L M A N A GEM ENT A N D CO O R D IN A T I O N A C T (Cap . 387; IN EXERCISE of the powers conferred by section 147 o f th e Environmental Management and Co-ordination Act, the C ab in et Secretary for Environment, Climate Change and Forestry, upo n recommendation of the National Environment M anagement Authority , and upon consultation with the relevant lead agencies, m ak es th e fol lowing Regulations— TH E EN V I R ON M E NT A L M A N A GEM ENT A N D CO ORDINATION (ACCESS TO BIOLOGICAL RESOURCES AND BENEFIT SHARING) (NO. 2) REGUL ATI ONS, 2025 PA RT I - PRE L IM I N A R Y PR OV I SI ON S 1. These Regulations may be cited as the Environmental C i tau on . Management and Co-ordination (Access to Biological R eso u rces an d Benefi t Sharing) (No. 2) Regulations, 2025. 2. In these Regulations, unless the context otherwise requires— “access” refers to obtaining, possessing and uti lizing biological resources and resultant progenies and their digital i nf orm ati on , including DNA , RNA , Proteins, chromosomes, plasmids, deri vati ves, extracts, compound and derived products and associated intangible components, for purposes of research, bio-prospecting, conservati on , industrial application or commercial use; “access perrmt” means a permit that allows a person t o a c c e ss genetic resources issuedunder regulation 4; “ biological resource” includes- (a) the genetic resources, organisms, microorganisms, derivatives and parts of the genetic resources; (b) the populations and any other biotic component o f an ecosystem with actual or potential use or value for humani ty ; Interpretat ion an d (c) any information relating to paragraphs (a) and (b); “benefi t sharing” means the sharing of benefi ts that acc r u e f ro m the util ization of genetic resources; ‘bio-survey and bio-utilisation” means survey or collection o f species, sub-species, genes, components and extracts of biological resource for any purpose and includes characterisation, i n v en to r i sat i o n and bioassay; “clearing house mechanism” means a web-based information portal establ ished by the Competent National Authority; ‘commercialization” means trade of biological resources f o r fi nancial gain; “community” means a homogenous and consciously distinct group of the people who share any of the following at tr i b u tes — 764 ^ Kenya Subsidiary Legislat ion, 2025 (a) ' communi t)^ ancestry ; (b) similar culture or unique mode of livelihood or l anguage; (c) geo^ phical space; (d) ’ ecological space; op (e) communi ty interest; “(Community Pfotocols” means a broad range of pf actices o r ' proteedureŝ both written and unwritten, developed by indigenous people or l ocal comm uni ti es in relati on to their tradi t i onal knowledge, territories-and'associated biological resources; “derivative” is-̂ a^ biochemical - compound ' derived, developed, synthfesized-'orTen'gineered, fr orn -a biologicm resource or resulting-̂ m the: genetic expression ̂ or metabolism- of - the biological - or ’ geneti c- resource; or -part ;-ti ssue or -extract , whether -it contains f unc ti o n al un i t s - of iberedi ty orfotherwise, and inf ormati on in r elati on to deri vati ves;- ‘TDi^ tal ) Ŝ uencing Informati on” it is- a; biological d ata associated-with; or 'derived fi om, geneti c resources su ch as- n u c l eo t i de sequences and epigeneti c, protein , and metaboli te data; “endangered •species' ’̂ means-any species which is in- danger of - extincti on'ithfough'out -all or a-signif icant porti on of its- range (due to man -made or-natural changes in the environment); “exoti c species” means any species of plant or animal o r microorganism (life form) whose natural range' does not , or -'did not in the-past;.exist' in’a’Specifi c part of , or the whole of , Kenya and' which out^ mpetes-all other ’lif e forms; “faipand equitable benefi t sharing” means sharing of benefi ts; “geneti c resource” refers to any Kdogical material w hi c h co n tai n s genesi or metabolic material that may be derived-f rom genes of plant, animal) microbial -'or the origin containing functi onal units of h'er^ ty', with;the gene being the basic physical and f unctional uni t of heredity ; “habi tat” means the-place or type of -site where an organism- or population' naturall y occurs and includes areas colonized by introduced organi sms; “ locali ty” refers- to geographical area in Kenya where th e biological-l esources ate found in-situ or ex-situ; “ Ideal community” mearfi â community in whose location biolbgical diversi ty resources are-situate d and includes a community of ' interest; holotype” means the single-specimen chosen for designati on o f a new species; “ intangible components” refers any informati on held by persons that -is associated with or regarding geneti c resources accesŝ within the j uri sdicti on of Kenya; “ inventory” means a detai led list, report or record of resources , or the-process of making such a list, report or record; 77.65Kenya Subsidiary Legislation, 2025 “materi al transfer agreement” means an agreement negotiated betw.een the holder of an access permit and a relevant lead agency (or community on access to genetic resources and benefit .sharing; “ mutuall y agreed terms” .means an .agreement between th e providers .and users of genetic resources .and/or traditional ,knowledge associated with genetic resources; “ natural .environment system” means relatively intact ecosystems of unique .value, such as perennial and .seasonal wet lands, highly ..diverse aquatic ̂ecosystems, or ecosystems promoting .a 'high .ooricentra tion of .rare and unusual species; “ non-commercial ” means for .academic purposes ..or mon-profi t ôri ented ; ^permi t” .means a wri tten authorization .issued by a .Competent 'Nation̂ Authori ty imder-these Regulations; 7permi t holder” refers ,to an .owner of ,a |.permit .issued by a ;Comppte nt National Authori ty under .these,Regulations; -“J?ri or Informed .Consent” means ̂ permission jĝiven Iby cCompetent Authori ty;respQn$ibietforiman!̂ ementoof ithej ?artieUlari.biolQgical 1 resource i in . coUabpration .with i.local j xjmmjjnities . in *the iform ..of a sign,̂ - agreenient with legal .enti ty : pri or .to.ft :;6essing6 iotogical re so u r ce ; “,Rrovider” 'm.eans either a'̂ iiomp.ete nt Nati onal ,Authori ty , County gov.emm.ents,or.adocal ,Gommuni ty depeu,diii g.onvwh.ere th e .r eso ur ces ito 'be.aGcessed.areiloPAted-.and the .tenuie r̂egime (in-that;Sj )ecifi c ilan.d; “ resource provideri ’iincludes— (a) •goyemm.ent agency, ippssessing ibiological resources lin ,i n- .s; tue.oaditionsj ((b) ̂government ̂ encŷ i n respect.of,.ex-situ:.biological>resoutc e , Vhereithe,resource .ori ginatesj ■(c) ,a govemnxept agency (holding .afbidlogic.al resource i n ŝx ^̂si tu condi ti ons, whether in .a.co'lLec,tion'.orvOth.erwise; ,(d) .government .agency, rf rom .where;the (resource is .accessed i n .sitp.ati.ons where— the 'biological iresource is held i n .ex - s it u conditi ons byia,pri vate body; (e) Jhe .indigenous .eornmunity and ilo,cal ifi ornmunity , -w her e dhe resoiuce is .on,land,,to\whichttheyihav.emtright; .(■f) the.in.digeno.us commuiuty .and i ocSl communi ty , w here they are the .holders of the ‘biological resource .associated w i th (traditional knowledge including ,menib,ers i.of ithe community who are‘tiadi tional .healers;v.or (g) an individvral , ,wherpi.theibiological ireaout ce is:taken '.fi x)m ; “sustainable use” ipieans .the ,.use ,of (Components -of ibiological <div.ersi ty i n such manner .and,at such irateithat d oes not il ead ito .theilong- term .decl ine of the ibiological diversi ty thereby maintaining i ts potenti al to meet the needs and .aspirations of ptpsent .and f uture generations; 7 6 6 Kenya Subsidiary Legislat ion, 2025 “ threatened species” means any species of plant or an i m al w h i ch is likely to become an endangered species within the f o r eseeab l e f utur e throughout all or signi fi cant portion of its range; “ traditional knowledge” means any knowledge— (a) originating f rom an individual , local or traditional communi ty that is the result of intellectual activity an d insight in a tradi tional context , i ncluding know-how , sk i l l s , innovations, practices and learning, embodied in the traditional Lifestyle of a community ; or (b) contained in the codi fi ed knowledge systems passed o n f ro m one generation to another including agri cultural , envi ronmental or medical knowledge, knowledge associated with genetic resources or other components of biological diversity , and know-how of traditional archi tecture, construction technologies, designs, marks and indications. 3. The obj ectives of these Regulations shal l be to— (a) provide mechanisms to protect and prevent exploitation of endangeredand threatened plant and animal species; (b) provide for access to and the fair and equitable sharing of benefi ts ari singf rom the utili zation of biological r e s o u r c e s ; (c) provide for the consultation of local communities an d other stakeholders in the process of accessing biological resources for research, bio trade, commercial and other p ur p o se s; (d) safeguard access to biological resources, and biological r e s o u r c e s associated with traditional knowledge heldby local c om m un i t i es in conservation of biological resources; and (e) to domesticate relevant provisions of international conventions and protocols. 4. (1) These Regulations shal l apply to— (a) the conservation of al l biological resources in Kenya, whether or not they are found in their natural environment; (b) access to genetic resources in Kenya and the fai r an d equitable sharing of benefi ts deri ved from their uti l ization; (c) approved research and acti vities that relate to biological resources and biological resources with associated t r adi t i o n al knowledge; (d) commercialization and trade in biological resources; an d (e) any digital sequence inf ormation relatmg to Kenya biological r e s o u r c e s . (2) These Regulations shal l not apply to— (a) the exchange of biological resources, thei r derivative products, or the intangible components associated with Objecti ves. A ppli cation. 7 67Kenya Subsidiary Legislati on, 2025 them, carried out by members of any local Kenyan community amongst themselves and for their own consumption and benefi ts; (b) access to genetic resources derived from plant br eed er s in accordance w i th the Seeds and Plant V ari eti es A ct and th e International Treaty on Plant Genetic Resources for F o od and A gricul ture; or (c) human genetic resources. Cap. 326. 5. The Authority shal l be the Competent National Authority Competent N ati on al A uthon ty .and shall be responsible for granting access a as applicable, issuing written evidence that access requirements have been m et an d h responsible for advising applicants, local communities, o th er Government agencies and any interested persons on the applicable procedures and requirements for obtaining prior informed co n sen t an d entering into mutuall y agreed terms. PART n - CONSERVATION OF BIOLOGICAL DIVERSITY 6. A person shal l not engage in any activity that relates t o access to biological resources and biodiversity that m ay — En v iro ni nen ta l impact assessment l i cence (a) have any adverse impact on any ecosystem; (b) lead to the introduction of any exotic species; (c) lead to the unsustainable use of natural resources; an d (d) operate a facil ity for the conservation of any species outside i ts natural habitat . without a valid Environmental Impact Assessment License i ssu ed by the Authori ty . 7. The Authority may, in consultation with relevant Co nser v at i on o f th re atened stak eh o l der s — spec ies . (a) prohibit, restrict or impose similar measures on th e ac cess an d use of any threatened species in order to ensure its regeneration and maximum sustainable yield; (b) on application by a qualifi ed person, issue approvals f o r th e establ i shm ent and m aintenance of f aci l iti es f or the r e c o v e r y and rehabili lhtion of threatened species; and (c) determine full recovery and rehabili tation measures of threatened species to ensure its restoration into its n atur al h ab i tat . 8. (1) The Authority shall , in consultation with the r el ev an t i nventory stakeholders, establi sh and maintain an inventory of all biological and biologî. r* 1 di v ersi ty , geneti c resources of the country . (2) The Authority shal l, at least once in every fi ve years, in consultation with stakeholders, undertake an assessment of the status of suc h reso u rces . (3) The inventory under sub-r^ ulation (1) shal l include a register of threatened, endangered and rare species o^ lants and ani m al s . of 76 8 Kenya Subsidiary Legislation, 2025 (4) The inventory establ ished under sub-regulation (1) shall be , re gujarly updated by the Authority in-between the fi ve-year period . (5) The mvQntory shall be a public record and shall be acc essi b l e in the m^ erprescribed by the Authority. 9. (1) The Authority shall , in consultation with relevant stakeholders, facilitate the recognition of traditional knowledge aŝ iated with genetic resources and practices in the management and conseiwation of biqlogiĉ resources. (2) jThe Authority, in consultation with relevant stakeholders, shall develop a community biodiversity register comprising o f mdigenpus and local community practi ces for conserving biodiversity Md uses of vm ous biological respurces. , (3), Each County Environment Committee shall , in c o nsu l tat i on with indigenous and local communiti es in the County, develop and , SHt’.Plit,.to ,the .Authppty community protocols for user engagement of t b̂iplpgiĉ 'respprqes. , (4) -TJie Authority shall partner w,ith local cpmmunities an d .incptp̂prate ’.Aeir ,to diti onal .knowledge and practi ces in tbe .cpnsê â pn of,biological resources. ;10. (1) Authority shal l ,,in consultati on with Ae relevant , ŝ pholdere , est^ lish rneaspres for the purpose of monitpring and , track̂ g the stotus and the components of biological r esp u r c es o r .'bjlplogical respurces ̂ sociated with, traditi onal knowledge ,in .Kenya ^ d.̂ den̂jbfy . acti .vities .p d,,processes that threaten, the sustainability of ,..̂ e,cbijntiy ’ s biological resources and diversity. ,(2) The 4,uthpfi ty shaU ̂ e correcti ve measures including an y ênf9i:Mment , acti ons ,.to.ded with any threate to the biodiversity of -̂ enya, or comppnents,of Ae biodiversity. PAKT, in - ACCESS TO BIOLOGICAL RESOURCES -.11. ,(-l ) Any j jê p who intends to access biological r e s p u r c e s o r -:biplogicd jcsburces.aî ciated .with traditi onal knowledge in Kenya ,Ŝĥ applŷ to the Authority in the form set put in-the E irst Schedule and ,accpmpanlpd̂by, the prescribed fees specifi^ in the Seco nd Sc h ed u l e . ,(2̂ v?yhere ,an applica.ti pn under suL,regulati on ,(1) is for non- ,.cpnipiprpjd,puip6ses andsliali— ,.(a) ..st̂ e the purpose,̂ durfition of seeking the access permi t; (b) ,.,be accompanied by .evidence of W or Informed C on sen t an d -l^upially A.greed Terms, from interested persons and .relev̂ t .ŝ eholdere, and a xesearch clearance certi ficate and ari y.ptnef clearanpes as applicable; rt(ĉ .sbpplate, the^pecific,locality4p be undertaken w i th G PS co- .b.fdinates; and ,(d) ̂cpntoip̂Jhe .Material Tnmsfer Agreement, .where apphcable. ,(3) The appUcmt .shall be the-Project Investigator as in di cated in th e Indigencms and local communi ty biodiversity m e a s u r e s . M qni tou ng Application for access .pem u t (non-commerc ial and commerc ial ) . 7 69Kenya Subsidiary Legislation, 2025 (4) Where an applicati on under sub-regulati on (1) is f o r commercial access, the applicati on shall — (a) state the purpose and duration of seeking the access permit; (b) be accompanied by evidence of Prior Informed Consent an d Mumally Agreed Terms from interested persons and relevant stakeholders where applicable; (c) include a benefi t sharing agreement with interested per son s and relevant stak eholders; (d) include the material transfer agreement; and (e) exclude any endemic species, rare species or any species protected under any written law or other relevant regulatory f ram ew o rk . (5) Every appl icant issued with an access permit in acc or dan ce with these Regulati ons shall stri ctly comply with the condi ti ons of that permi t . (6) Where the purpose, locali ty or quanti ti es for which the permit was initi ally issued changes, the applicant shall promptly notify the Authority of the change and apply for a new access permit . (7) Any person who contravenes the provisions of this regulati on commi ts an of fence and shall be li able to the penalty specifi ed in sec ti o n 144 o f th e A ct . (8) Where a person who has been granted an access permit u n d er this regulati on contravenes the terms and conditi ons of the permit, the A uthori ty shall cancel that permit . 12. (1) The Competent Nati onal Authori ty shal l guide th e applicant on the relevant biological resource providers fi ro m w h o m M or Inf orm ed Consent is to be obtained . Pn or in f o rm ed co n se n t mutual l y-agreed t e r m s . and (2) The Prior Informed Consent of the relevant local communi ty shall be obtained in accordance with customary laws, practi ces, protocols and procedures of the community for any access t o — (a) biological resource which such local community has a right; an d (b) biological resource associated with traditi onal knowledge that is held by such local community . (3) The terms of such consent shall be agreed between th e applicant and the geneti cprovider and developed into M utuall y Agreed T erm s . (4) The applicant shall submit to the Authority the Pr i o r I n f o r m ed Consent set out in the Third Schedule and the Mutual ly A greed Terms set out i n the F if th Schedule. 13. The Authority may, upon receipt of an applicati on u n d er regulati on 11, publish the applicati on in at least one local newspaper with nati onal coverage and in such other manner as the Authori ty may considerappropri ate at the cost of the applicant, specifying- Pub b caUon of application for as-ccss permits. Kenya Subsidiary Legislati on, 20257 7 0 (a) the name and other particulars of the appli cant; (b) the location of the biologieal resources for which ac cess h as been applied for ; (c) the activity to be undertaken for whi ch the access permi t is required; and (d) the time within whi ch representations or obj ections i n respect of the proposed access permi t may be made to th e A uthori ty . 14. (1) The Authority shal l process an appli cation f o r an acc ess permit within thir ty working days f rom the date of the receipt of that appli cation. D eterm in ati on o f an access permi t (2) The decision of the A uthority on appli cation for a n a c c e s s permi t shal l be made in wri ting. (3) Where an appli cation submi tted to the Authori ty i s incomplete or an issue has been raised by the Authori ty , the period speci fied in sub-regulation (1) unti l the appli cation has been completed or the issue raised by the Authori ty has been addressed, as the case may be . 15. (1) The Authori ty shal l , on receipt of comments on th e Grant or ref usal to proposed appli cation for access to biological resources, rev iew "the ̂ rant appli cation and i f sati sf ied that the activity to be ca rr i ed o u t sh al l promote the sustainable management and util isation of biological resources, issue an access permit specifi c to each local i ty . (2) Where the Authori ty has reasonable grounds to decline issuance of an access permi t ,it shal l inform the appheant o f th e r easo ns of such dechne in wri ting. (3) A person aggrieved by the decision of the Authori ty m ay appeal against the decision to theTribunal . 16. The Authori ty shall , within thir ty waking days of receipt of an appli cation for an access permi t , determine the appli cation an d communi cate its decision in wri ting to the appl icant . 17. (1) An access permi t shal l be valid for a period of one year Validity and f ro m th e date o f i ssu e an dsh al l n o t be tr ansf er ab l e . (2) Upon expiry , an access permit may be renewed for a f ur th er period of one year only— a c c e s s Co mm um cati on of deci si on . n o n transferabil i ty of access perm i ts . (a) upon payment of the fee prescribed in the Second Schedule; an d (b) upon such termsand conditions as the Authori ty may impose. 18. (1) The Authority may impose terms and conditions o n a n access permit as i t may determine in the chcumstances. (2) In addition to any terms and conditions that may be imposed by the Authori ty on an access permit under sub-regulation (1) , the fol lowing conditions shal l apply in respect of each access permi t — T erm s co ndi t i ons o f access permi ts. and Kenya Subsidiary Legisla ti on, 2025 1 1 1 (a) any duplicates and holotypes of all genetic resources collected shall be deposited with the Authority and o th er relevant stakeholders; (b) the records of all intangible components of biological material collected shall bedeposited with the Authority; (c) reasonable access to aU biological resources collected sh al l be guaranteed to aU Kenyan citizens whether such genetic resources and intangible components are held locally o r abroad ; (d) any agreements entered into with respect to access t o biological resources shall bestrictly for the purposes f o r w h i ch they were entered into; (e) the holder of the access permit shall furnish biannual and annual repKsrts to the Authori ty on the status of research an d commercial ization including any discoveries from research involvmg biological resources or intangible components thereof ; (f ) the holder of an access permit shall inform the Authori ty of aU discoveries made during the exercise of the right o f acc ess granted under the access permit; (g) the holder of an access permit shall provide the fol lowing repor ts— (i) a semi-annual status report on the environmental impacts, conservation status and sustainable use of an y ongoing collection of biological resources or intangible components thereof ; and (ii) a fi nal status report on the environmental impacts, conservati on status and sustainable use of coll ecti on o f biological resources or intangible components thereof , i n the event that the col lecti on is of durati on of thr ee months or less; and (h) the holder of an access permit shal l fuUy comply w i th th e provisions of the Act, these Regulations and any other relevant written law relating to access to biological resources, benefi ts sharing, prior informed consent, m ater i al transfer agreement, trade in biological resources, th e protection of traditional knowledge, and any other r el ev an t m a t te r . (3) The Authori ty may , on i ts own motion or on the appl ication by the holder of an access permit, vary the terms and conditions imposed on an access permi t . 19. (1) The Authority may suspend, cancel or revoke any access Suspension, permit issued under these Regulations where the holder o f th e acc ess permit has contravened the provisions of the Act, these Regulations or any of the terms and conditions imposed on the access permi t , or the terms and conditions contained in any agreement concluded pursuant to the grant of the access permit. can cel lat i on an d rev ocat i on o f access permi ts Kenya Subsidiary Legislation, 2025i n (2) The Authori ty shall , before suspending, cancelling o r re voking an access permit, give a wri tten notice of i ts i ntenti on to suspend, cancel or revoke the permit to theholder of the access permi t , and give the holder a reasonable opportunity to make presentations regarding the proposed suspension, cancellation or re vocati on w i thin thirty waking days fr om the date of such notice. (3) Where the Authori ty suspends, cancels or re vokes a permit, it shall notify the holder of the permit in wri ting, specifying th e r easo ns for the suspension, cancellation or re vocation. (4) Upon the notifi cation under sub-re gulation (3), the permit holder shall immediately surre nder the access permit, al l r esear c h results and re lated documents, and the accessed biological r e s o u r c e t o the Authori ty . 20. (1) The Authori ty shall keep, manage and uj^ te a re gister of all access permits which it has granted, and the re gister shal l be a public record accessible to any person upon request. (2) The Authori ty shall upload the access permits to th e A ccess an d Benefi t Sharing Clearing House Mechanism of the Nagoya Pr o toco l to be documented as the Internationally recognized Certifi cate of Compli ance. PART r V- M ATERIAL TRAN SFER AGREEMENTS 21. (1) A person shall not transfer biological resources o u tsi d e Kenya unless a Materi al Transfer Agreement in the form se t o u t in th e Shrti i Schedule has been executed and where applicable negotiated between the re levant competent national authori ties an d th e u se r s . (2) A Materi al Transfer Agreement shall be executed by the applicant on the one part and the provider of the biological r e s o u r c e . (3) Upon execution, the user of a Materi al Transfer Agreement shall fi le the Materi alTransfer Agreement with the Authori ty . (4) A person exporting a biological resource shall be requi red to declare the resource at the port of departure and produce a copy of the M aterial Transfer Agreement . (5) An exporter of a biological resource shall deposit a holotype of the materi al being exported either with the enti ty granting Materi al Transfer Agreement or any depository gazetted by the Authori ty for storage of such holotypes in Kenya. (6) Any person who seeks to transfers any biological r e s o u r c e s outside Kenya otherwise other than in accordance these Regulations commits an offence and shal l be liable, upon conviction to the penalty prescri bed in section 144 of the Act . PA RT V - B EN EFTT SH A R I N G 22. This Part shal l apply subject to the laws in force re lating to intel lectual property ri ghts. 23. (1) An applicant of an access permit to a biological r e s o u r c e biological resource associated with traditional knowledge f o r n o n - Register of access permits. M ateri al transf er agreements. a Appbcation of Part . Benefi t sharing . o r 7 7 3Kenya Subsidiary Legislation, 2025 commercial or commercial purposes shall enter into a benefi t-sharing agreement with the biological resource provider. (2) A benefi t shari ng agreement shall be based upon M utual ly Agreed Terms and provide for fair and equitable benefi t sharing. (3) Benefi t shari ng shall include both monetary and n o n monetary benefi ts. (4) Monetary benefi ts include— (a) access fees or fee per sample collected or acquired; (b) up-f ront payments; (c) milestone payments; (d) payment of royalties; (e) license fees shall be payable where biological r es o u r c e s a r e to be utilized for commercial purposes; (f) fees to be paid to trust funds supporting conservation an d sustainable use ofbiodiversity ; (g) salari es and preferential terms where mutually agreed; (h) research funding; (i ) j oint ventures; (j) joint ownership of relevant intellectual property ri ghts. (5) Non-monetary benefi ts include— (a) sharing of research and development results; (b) recognition; (c) collaboration, co-operation and contri bution in sc i en t i fi c research and development programmes, particularly biotechnological research activities; (d) participation in product development; (e) admittance to ex-situ facilities of biological resources and to databases byparticipating institutions; (f) transfer to Kenya of biological resources of knowledge m d technology under fair and most favourable terms, including concessional and preferential terms where agreed, in particular, knowledge and technology that make use o f biological resources, including biotechnology, or that a r e relevant to the conservation and sustainable uti lization o f biological diversity; (g) strengthening capacities for technology transfer to Kenya; (h) institutional capacity building; (i) human and materi al resources to strengthen the cap̂ ities for the administrationand enforcement of access regulations; 7 74 Kenya Subsidiary Legislat ion, 2025 (j) training re lated to biological re sources with the f ul l participation of Kenya andwhere possible, in Kenya; Qc) access to scientif ic inf ormation re levant to conservation an d sustainable use of biological diversity, including biological inventories and taxonomic studies; G) institutional and professional re lationships that c an ar i se f rom access and benefit sharing agreements and subsequent col laborative activities, and (m) joint ownership of re levant intellectual property ri ghts. PART VI - MI SCEL LANEOUS PROVI SIONS 24. (1) The Authority may, on the request of an applicant o f an access permit, hold some information re lating to access to biological r eso u r ces as co n f i den t i al . (2) Where an access permit is granted, information h el d as confidential under paragraph (1), with respect to the relevant apphcant , shall not be accessible to a person inspecting the re gister of permi ts in accordance with regulation 17 25. A person carrying out any activities involving a c c e s s t o biological re sources unmediately before the commg into f o r ce o f th ese Regulations shal l, within six months from the coming m to f o r ce thereof , take aU necessary measure s to ensure full comphance with these Regulations. 26. The Authority shal l encourage the use of Alternative Dispute re solution in disputesarising under these Regulations. 27. A contravention or failure to comply with any of th e matters provided in theseRegulations shal l consti tute an o f f en c e . 28. Any person convicted of an of fence under these Regulations, for which no penalty is specifi ed, shall be liable upon conviction, to the penal ty speci fi ed m secti on 144 of the A ct . 29. The Envi ro nmental Management and Co-ordination (Conservation of Biological Diversity and Resources, A c ce ss to Genetic Resources and Benefi t Shanng) Regulations, 20 2 5 re v ok ed . Confi dentiality . a c c e s s T ransi t i on . Dispute reso lu ti on . O f f ences . Penal ti es R ev ocat i on L Jvf 19/2025 a re 7 7 5Kenya Subsidiary Legislat ion, 2025 F I R ST SC H E D U L E (Regulation 11(1)) A PPL I CA T I ON FOR A CCESS PERM I T Applicants applying as individuals should fill Part 1. Applicants applying as corporate (organizations) should fi l l Part n . AU appli cants must fi l l P ar t i n . All applicants must submit two (2) hard copies and one (1) soft copy of this application to the A uthori ty . PA R T I - FOR A PPU CA N T S W H O A RE IN D I VID U A L S (a) Name of appli cant (b) Identi fi cation Card No yPassport No (c) Postal A ddress (d) PIN No (e) Permanent Residential Address (f) Quali fi cations (Curriculum Vitae to be attached) (g) Letter of introduction conf irming that the student is duly registered in the Academic or Research Institutions and is approved to undertake r esear ch . Detai ls of the relevant qual ifi cations, roles and responsibili ty of each person proposing to take part in the research (i e . access biological resources under thi s perrmt) . Responsibili tyQualifi cationsN am e PART n - FOR APPLICANT S WHO ARE CORPORATE ORGANI SATIONS Co Appli cant 2Co Appli cant 1Appli cant Name of A ppl icant Name of Organization P er m an en t A dd res s P h on e N um ber s Registration No. Attache copy of certifi cate of registration Quali fi cations of the individuals in the proj ect (Curri culum V itae to be attached) 7 76 Kenya Subsidi ary Legislat ion, 2025 A f f i l i ated in st i tu t i o ns Any other relevant i nf o rm a ti on Name of the contact person in regard in the organization PA R T m - F O R A L L A P PU C A N T S to this appli cation and the posi tion held 1.0. Access purpose (Please tick one) (a) Non-commercial (b) Commercial T itle of the proj ect/research/commercial action 2 .0 . F in an c i al detai l s so u r ces (a) The total budget of the proj ect (b) Detai ls of any corporate or individual sponsors of the proj ect 3.0. Technical particulars (a) What are the detail s of your previous collection/ research (i f any) conducted in any of the East Af rican Communi ty? (b) With regard to biological resources for which access is sought , the fol lowing must be provided: (i) Name of speci fi c sites in which access will be u n der tak en an d th e G P S l oc at i o n (ii ) Identi fi cation (Scientifi c names of taxa) of biological resour ces an d i ts traditional use where appli cable (iii ) Parts of the biological resource to be collected (tissues, cel l s, seeds , leaves, microbes, etc) (iv) Derivatives and/ or products (v) Quanti ties of biological resourc es to be col lected (give the schedule) (vi) Description /nature of traditional knowledge of any known uses of the biological resources (oral/ documented) (vii ) In case of genetic resources held ex-si tu , detai ls o f th e rel ev an t depository insti tution(s) (c) With regard to the plaimed col lecting mission, the following must be provided: (i) Identification of the provider(s) of the genetic r eso ur ces f o r w h i c h access is sought (u ) Col lecti on methods to be used (ii i ) Detai ls of Kenyan nationals and insti tution which wi l l participate in the Research and Development activities and thei r particulars Kenya Subsidiary Legislat ion, 2025 1 1 1 (iv) expected date of commencement and completion of the activi ty ' (v) inf ormation regarding immigration status in K enya of forei^ individuals that wil l visit Kenya (d) Proposed use of genetic resources: The purpose for which the access i s requested including the type "and“ extent of research, commercial use being deri ved and expected to be' d er i v ed fr o m i t (ii ) destination of accessed biological resource and geographic identity 'bf the location where the R&D wil l be carried out ' (ii i ) Probable subsequent destinati ons (iv) Identify how access to these biological resources w i l l biodiversi ty conservati on. Speci fy any likely benef i ts for the "access ‘ a r e a (i ) C o nser v ati o n B en ef i ts (v) Identify the use (if any) that is proposed to be made of Indigenous people’s knowledge in determi ning the biological resources t o be accessed or the parti cular areas to be searched (vi) Provide details of any person not already named o n th i s f o rm o n w h o se behal f access is sought or who proposes to use the samples obtained N am e I n sti t u t i on A d dres s Purpose of access (e) Proposed mechanism and arrangements for benef i t sharing the Appli cant of fers for access to biological resources Amount/Quanti ti esType of Benef it (f ) The economic and other benef i ts including those arri ving out of any Intel lectual Property Rights, patent obtai ned out of accessed biological r eso ur ces an d 77 8 Kenya Subsidi ary Legislat ion, 2025 knowledge that are intended, or may accrue to the applicant or to the country that he/she belongs The biotechnological , scientifi c, social or any other bene fi ts o b tai ned ou t o f accessed biological resources and knowledge that are intended , or may accrue to the applicant or to the country that he/she belongs Estimation of benefi ts, that would flow to Kenya / communities arising out of the use of accessed biological resources and trai tional knowledge. Will the applicant require assistance to identify and access the genetic resources described in this application? If yes, give detai ls o f th e ass istan ce th at w il l be required. A copy of the Prior Informed Consent document signed by the relevant lead agencies, local community or private owner of thegenetic r e s o u r c e s , copy of research clearance documents f rom relevant r esear c h i nst i t u t i ons Any other information in the possession of the applicant whi ch might be useful for the National Environment M anagement Authority to m ak e an informed decision in granting an access permit. (g) (h) (i) 0) (k) (1) 4 1) . R enew al de tai l s Is thi s an appli cation for renewal of an access permit? Y es N o A c cess P er m i t N o . G r an ted o n (Date) Al l appli cants are forewarned that it is an ■ f fer cj to give false information to the National Environment Management Author ly punishable un der th e E nv ir o nm en tal M anagement and Co-ordination (Access toBiological Resources and Benefi t Sharing) Regulations. I undertake to provide progress and full repori i as required under the Regulations. I declare that to the best of my k.iov/ledpe tne information given in respect of this application is true. For individual applicani. : Name of Appl icant Signature D ate For Companies/Institutions: (A f fi x company seal) / " t In the presence of : N am e o f D i r ec to r Signature Name of Dir ector/Company Secretary : Signamre D ate Kenya Subsidiary Legislat ion, 2025 77 9 SE C O N D SC H E D U L E (regulati ons 11(1), 17(2)(a)) Fees per locali ty N o n -c o m m er c i al acc ess Citizens (K sh.) Foreigners (K sh.) 80 ,000I n d i v id u al f ee s 40 ,000 Corporate fees 100 ,000 200 ,000 Kenyan students fee (This fee only applies for students researching in Kenyan academic and research Institutions, for foreign msti tutions the non-commercial fees apply) K sh . 3 .000M aster s S tu d en t F ee s 1 Ph D C an d i d ate f ee s 10 ,000 C o m m er c i al ac cess Citizens (K sh .) Foreigners (K sh.) 1,000 ,000F ee f o r co m m er c i al i sat i o n 500 ,000 A ccess permit renewal Citi zens (K sh.) 30 ,000 Forei gners (K sh .) 50 ,000Individual appl ication Corpo rate appli cati on 1 l OODOO50 ,000 Kenya Subsid iary Legislation, 20257 80 T H I R D SC H E D U L E (regulation 12(4)) A C C E S S PE R M I T This permit is hereby granted to M/s (insert name, contact address and description of appl icant) in accordance with regulation 11 of the Environmental M anagement and Co ordination (Access to Biological Resources and Benefi t Sharing) Regulations, 2023 for the collection of the foll owing genetic resources: (insert description of the biological resource, its derivative product(s) or intangible component(s) as stated in the M aterial s Transfer Agreement) located at (Insert geographical description of the location of the biological resources) This permit is issued subject to the Regulations and all agreements concluded pursuant to its grant, and maybe suspended, cancelled or revoked should the holder breach any of those agreements and the condi tions of issue and those contained in the Regulations. .(insert name of applicant) being the holder of this permit, including his agents and assignees, undertake to abide by the conditions of thi s permit and to promptly report to the National Environment M anagement Authori ty any matter that may prejudice the interests of Kenya and other parties concluded pursuant to the grant of thi s permit . Signed: Director General , National Environment M anagement Authori ty , day of M / s , D ate : ,, 20D ated th e Kenya Subsidiary Legislat ion, 2025 7 8 1 F O U R T H SC H E D U L E (regulation 12(4)) PRI OR INFORM ED CONSENT (PIC) PRI OR INFORM ED CONSENT FOR A CCESS TO AND UTIL ISATION O F (Biological resource to be accessed and its utili sation) (The title is der ived f rom the access demand . The user has to state clearly what is being accessed. This comes last) T hi s Pr i or I nf orm ed Consent here in ref erred to as the PIC agreement is entered on this by and between: (the date is entered by the last signatory, in most cases the national competent authority granting the PIC) STAKEHOLDERS (the key stakeholders to be party to the PIC are to be clear ly mapped out) Pr o v i der s : Insert the legal ly mandated providers at the national , county and local community where possible T h e U ser s Insert al l the users who will be party to the agreement . T h ese in c lud e the institutions where the collected material and resultant progenies, der ivat ives, extracts, DNA/RNA, D igital Sequence Inf ormation and compounds, data analysis Istorage will be used within the value chain o n r esear c h and development W I T N E S SE T H These are whereas clauses on general principles of engagement for the providers an d u se r s (In general it states the guiding laws, the parties to the agreement and the ar eas of mutual agreements) NOW THEREFORE, IT IS HEREBY AGREED by the parties as f o l l o w s: This section state signi fi cance of the proj ect , broad impact and intellectual meri t which range f rom, but not l imited to conservation (ex-situ and in-si tu), scientifi c col laborations, benefi t shari ng and technology transfer For example, signifi cance/contri bution of the proj ect in the following , areas'but not limited to (this a very important area that brings out relevance of the project) Legal f ramework, policy and institutional arrangements Local ity of the proj ects and activities Contributions to science -the innovations the proj ect brings on board Capacity bui lding Par tnerships-in line with CBD/Nagoya protocol -scientif ic Ethical compliance including respect to IPLC rights Contr ibution to resource thobilization strategy da te 1. n . ;m . Kenya Subsidiary Legislation, 20257 82 I V . PA R TN E R SH IP FRA M EW ORK These include the agreed the roles and responsibihties of each partner in the project, an agreed procedure on sample quantities and collection protocol including labeUing, verification, coding and key repositories. T h i s i s b ased on the outcome of the consultation process and stakeholders mapping and their roles. Key areas include: (a) The parties, providers, and users (the lead institution) (b) The access demands. That is what is being accessed and uti l ized (th is inf orms the title of the PI C) (c) Experimental . Details, what will be done where and by whom (inf ormed by what has been agreed and involvement of the providers); Field (where), Lab work where and why, Data analysis and storage, whereby whom and why (d) Declarations of previous undertakings -eg accessed genetic resources and data related to the proj ect/program where stored and a c c e s s , (e) Protocols f or access and ver if icat ion (f ) Involvement of resource providers in the activities where appropr iate V . B E N E F I T SH A R I N G A clear demonstration of outputs on benefit sharing both monetary and non monetary as envisaged under Nagoya Fhotocol and the country ’s domestic laws. This may include but not l imi ted to: (a) Non-monetary benef its Outcomes on technology transfer quite key arismg from; Capacity development within the scienti fic community e.g ski lls, sho r t term an d long-term training, exchange programmes etc for both providers and users; equipment, infrastructure Capacity development at community level (rural target groups); Baselme IP audit; Dissemination of resu l ts . A n o u t l in e o f results uptake, inception meetmg, scientif ic workshops t o th e re l ev an t stakeholders, publ ications among others. (i) Capacity building on ski lls - Training at certif icate levels, dip loma, undergraduates, Masters, PhDs, Post doc. State the number f or both provi^ rs and users and at what level will benef it or have benef ited f rom the programJproj ect (ii) Specialized training and exchange program; Special ized c o ur se eg a method of detecting a rat poacher while in the offi ce. Target group Wildlif e rangers ,10 in number f or 5 days etc, Pablo a nd team w i l l b e visiting the Antarctic to see ex-situ preservation of biological resources accessed f rom Sudan etc (Hi) Technologies being transf er red (iv) Facilities and equipment. State f acilities and equipment that will be acquired by the proj ect and where will they be hosted. T h is i s determined f rom the provided detailed approved proj ect proposal (v) Outreach plan; Inception and proj ect completion; M ed ia a ssets , sensitization!awareness creation, publication etc. Kenya Subsidiary Legislat ion, 2025 7 83 (b) M onetary benef its This wil l include the proj ect seed money or venture capital , incentives, upf ront , royal ties, mi lestones, bonuses etc State the program/proj ects grants~as per the grant l et t er Any employed on the proj ect/program IP assets exp loitat ion and share of benefi ts -IPR on P a ten ts an d media assets f or examp le VI . COMPLIANCE WITH LEGAL REQUIREMENTS 1. The users complying with the permit require ments f or access and uti l i zati on of the stated biological re sources; 2. Provisions with the Intellectual Property rights; 3. Consider issues of third-party transfers and ownership; 4. Applicable laws and dispute resolutions. This to co n si der th e acc essed material utilizati on value chain and juri sdicti ons. 5 . A m en dm en ts 6. These PIC agreed terms wil l form the basis for the co l labo r ati v e Memorandum of Agreement (Memorandum of Agreement/Materi al Transfer Agreement)) and Material Transfer Agreement to be signed (users) and providers IN WITNESS THEREOF, the parti es execute these agreed terms, and (provider) give consent to co l l ec t F O R A P PU C A N T S : TH E U SE RS Name of authorized enti ty P o si ti o n in in sti t u ti o n/ R ank I n sti t u ti o n an d ad dr ess E m ai l ad dr e ss Signature D ate Inst itutional stamp TH E P R O VI D E RS Name of authorized enti ty P o si t i o n i n in sti tu ti o n/ R an k I n st i tu t i o n an d ad dr ess E m ai l ad dr ess Signature D ate Insti tutional stamp Every page should be signed by the legal enti ty be tw een th e (user) under the (biological materi al) for the proposed project acti vi ti es. (proj ect) to undertake re search and Kenya Subsidiary Legislation, 20257 84 F I F TH SC H E D U L E (regulat ion 12(4)) M U T U A L L Y A G R E E D T E R M S M E M O R A N D U M O F A G R E E M E N T F O R - K E N Y AC O L L A B O R A T I V E R E SE A R C H O N B E T W E E N x x x x x x x x x A N D x x x x x x x x x x x x x x (PROVI DER OF BIOLOGIC^ RESOURCES) 7 85Kenya Subsidiary Legislation, 2025 M UT U A L L Y A GRE E D T ERM S M E M ORA ND UM OF A GRE EM E NT B E T W E E N x x x x x x x x x x x x x x x an d Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y Provider of Biological Resources PR E A M B L E W h er eas: 1. Kenya is endowed with vast biological resources and is among the mega biodiversity rich countnes globally, wherein the Constitution of Kenya is the crystall ization of the welfare of the people of Kenya including the need for conservation and use of natural resources of Kenya, wherein the sovereign rights over biodiversity are vested in the State in trust for the people, and under Article 2 (5& 6) the general rules of international law and any treaty or convention rati fied by K enya forms part of the L aws of Kenya. 2. Access to biological and genetic resources and associated knowledge is governed by various MultUateral Environmental Agreements (MEA s) mcluding but not limited to CBD, Nagoya Protocol , Intern ational Treaty on Plant Geneti c Resources f or Food and Agriculture (ITPGRFA), Convention on International Trade on Endangered Species (CITES) and World intellectual Property Organization Treaties (WIPO) among others, subj ect to domestic legislation 3. Access to biological/genetic resources and associated knowledge of K enya is subject to the existing domestic laws, and subject to Access Permi t , research licenses, Prior Informed Consent (PIC) , M utual ly A greed Terra s (MA T) and M aten al Transfer Agreement (MTA) between providers and users 4 . •are desirous in undertaking5. The govern ments of Kenya and col laborative research in infectious diseases including xxxxxxxxxx , whi ch is part of ful fi lment of the coopieration in thei r bi lateral agreements. 6. Research & Development (R&D) in biodiversity is key to conservation and sustainable use of biological resources for development done tluough partnerships in research and capacity building. 7. Resource management is devolved whereby we have shared resjxinsibi lities between the national government and the County govern ments including grant of user rights. The role of communities as custodians of indigenous knowledge and their contribution to conservation of biological diversi ty , they are entitled to equitable share of the benef i ts deri ved f rom uti l i zati on thereof and associ ated knowledge as per Kenya’s Consti tution, CBD and the Nagoya Protocol . 8. Under the W il dUf e (Conservation and M anagement) Act 2013, KW S is mandated to conserve and manage wildlife wherever they may be found in K enya including conducting research for the benefit of the people of Kenya, and KWS is a 7 86 Kenya Subsidiary Legislat ion, 2025 competent authori ty for prior inf ormed consent (PIC) , mutually agreed terms (M AT) and material transfer agreements (MTA) for wildlife resources and associated knowledge on behalf of the Government of Kenya. 9 . X x x x x x x 10. yyyyyyy This Memorandum of Agreement (Memorandum of Agreement) recogni zes the role of research and development for informed decisions on biodiversity conservation and li veli hood support through control of vector xxxxxxxxxxs an d x x x x x x x x x x . Parties to thi s M emorandum of A greement consent to implement the project in line with the provisions of the CBD and its Protocols (Nagoya and Cartegena) and relevant national legislations. NOW THEREFORE through the implementation of thi s M emorandum of A greement , the parties hereto have agreed to pursue their common goals as her eu nder A R T I C L E 1 - D E F IN r n O N A N D I N T E R P R E T A T I O N O F T E R M S In thi s Memorandum of Agreement unlecc in consistent w ith the context , or otherw ise specif ied , the following words and phrases snai l have the meaning set out below : Access shall mean obtaining, possessing and using genetic resources conserved , whether derived products and, where applicable, intangible components, for purposes of research, bio- prospecting, con:er \ ation, mdustrial appl ication or commercial use as def ined in the laws of K enya. Accession shal l mean a sample or specimen of biological or genetic material and/or information held in any legally approved repository centers, such as herbaria or gene banks. Acquisition shal l mean obtainmg biological material or resources through collection under the approved permit . A f fi l iate shal l mean any corporation, fi rm , l imited l iabi li ty company , partnership or other entity that directly or indirectly controls or is control led by or is under the common control of a party to this Agreement . Benefi t sharing shal l mean sharing of benefi ts f rom ac cess an d u t i l iz at i on o f biological resources and biological materials, and their denvatives, progeny , genetic inf ormation associated knowledge whether , commercial o r o th erw i se as stated in this M emorandum of Agreement and as defi ned in the CBD , Nagoya Protocol , Consti tution of Kenya, W ildlif e Conservation and M anagement A ct 20 13, and the relevant Laws of Kenya, where applicable. Biodiversity shall mean variabi l ity among l iving organi sms f ro m al l so u r ce s includmg, mter ali a, terrestrial , marine, and other aquatic ecosystems and ecological complexes of which they are part, this shall include diversity within species, between species and ecosystems. Biological resources shal l mean genetic resources, organi sms or part thereof , population, or any other biotic component of an ecosystem an d th e ir der i v at i ves with actual or potential use or value for humanity. Confi dential Information shal l mean scientifi c, business o r fi n an c i al in f o r m at i o n that has been reduced to writing and marked as “Confi dential” , provided that such mformation does not include information in public domain o r av ai l ab l e f ro m 1 .1 . 1 .2 . 1 .3 . 1 .4 . 1 .5 . 1 .6 . 1 .7 . 1 .8 . 7 87Kenya Subsidiary Legislation, 2025 others sources who are not under a conf identiall y obl igation to th e so u r c e o f information, information which has been made avai lable by its owners to others without a confidentiality obl igation, information which relates to potential hazards or cautionary warnings. Conservation area i ncl udes but not l im i ted to an area legal ly designated for conservation of biodiversity and shal l include protected and unprotected areas. Deri v atives shal l i nclude but not l im i ted to m odi fi ed o r x x x x x x x x x x o d i f i ed extracts and any compounds or chemical structure based on/or derived f rom plant , microbial and animal biological and/or genetic resources and their progeny , mcluding analogues Designated Repositories shall mean institutions mandated to keep in safe custody different categories of biological resources, including voucher specimens and new taxa, deposited with them by various users. Genetic material s shal l mean any material s of plant, ani mal , mi crobial or other origin containing functional unit of heredity. Geneti c Resource shal l mean inf orm ati on contai ned in any genetic material or their derivative of actual or potential use or value for humanity . Holotype shaU mean the organism known to have been used when the species was formall y described. Intellectual Property shall mean without limitation, inteUectual property rights including patent rights, and unpublished patent applications, any invention improvements and aU discoveries that may be not predictable, mcludmg aU know how , trade secrets, research plans and priori ties, research resul ts and created reports, statistical models and computer programs and related reports, and market interests, trademarks, copy rights, plant breeders rights, and product ideas of any of the parties and affi liates in existence at the time of execution of this agreement or subsequently developed or acquired independently of this agreement . Know how shall mean knowledge and ski ll s that enables a person to accompli sh a particular task or to operate a particular device or p roc e ss . L i cense shal l mean a w ri tten agreement gr antmg permi ssion t o u se an i n tel l ec tu al property nght within a defi ned time context, market l ine or territory . Material Transfer Agreement (MTA) shal l mean a contract be tw een th e resou r c e provider and recipient. For purpose of this Memorandum of Agreement shal l al so include a contract f rom KW S authorizing the use of biological resources and associated knowledge. Partners shall mean insti tutions party to this M emorandum of A greement . Principal Investigator(s) shall mean the person or persons designated by parties to this Memorandum of Agreement responsible for the scientifi c an d tec hn i c al conduct of the Memorandum of Agreement’s proj ect activities. Pn or Informed Consent (PIC) shal l mean permission given by the competent provider national authority and where jxissible in collaboration with county governments and local communities in the form of a signed agreement with legal entity pnor to accessmg genetic resources, in line with an appropriate national legal and institutional framework on access of biological diversi ty , biological resources or associated knowledge. 1 .9 . 1 .10 . 1 .1 1 . 1 .12 . 1 .13 . 1 .14 . 1 .15 . 1 .16 . 1 .17 . 1 .18 . 1 .19 . 1 .20 . 12 1 . 7 8 8 Kenya Subsidiary Legislation, 2025 12 2. Products shall mean any subj ect of invention and any commercial ly valuable or otherwise useful material , compound, isolate, or useful co m b in at i on o f compounds, i solates or other materials discovered , recovered , obtained , deri ved , resultmg or otherwise isolated f rom scienti f ic research c o n du c ted o n a r esear c h speci men or sample acquired fr om an authorized source, or any derivative of such material or compound, or other isolate, or discovery whi ch is or may be patentable and/or protected under Intel lectual property laws of Kenya and developed from research specimen acquired from the resource providers. 1.23. Progeny shaU mean any xxxxxxxxxx modi fi ed descendant and/or hybrids f rom research specimens such as virus fr om vi rus, ceU f rom ceU or organism fi em organi sm that are cul tivated by the user . 1.24. Proj ect Implementation Commi ttee shal l mean key body within the governance structure of the proj ect responsible for the research and management aspect of the project essential to the ensuring the delivery of the proj ect outputs .and the attainment of proj ect outcomes. 1.25. Provider shal l mean the custodian of biological or genetic resources associated knowledge as defi ned under the constitution and Kenyan laws. For aU purposes and intent K W S shal l be the Prov ider on behal f of Governm ent of Kenya and County governments.under this M emorandum of A greement as per the Wildli fe (Conservation and M anagement) Act 2013, -Environment M anagement and Coordination A ct 1999 and Consti tution of K enya. 126. Repository shal l mean designated facili ty within i n st i tu t i o ns w h er e d i ff er en t categories of biological reference collections, including voucher specimens, are preserved . For thi s M emorandum of A greement , XX JOOCXXXX X , XXX XXXXXXX and XXXXXXXXXX shaU host such designated f ac i l i t i es . 127. Research specimen shall mean the biological resources, progeny , derivatives or product the recipient has authority fr om resource provider(s) through the PIC, Wildli fe Permits and other relevant permits issued by KWS, National Environment M anagement Authori ty (NEM A) and National C o m m i ssi on f o r Science Technology and Innovation (NACOSTI ) or which o th er w ise w er e originall y and lawful ly col lected from Kenya. 1.28. Sample area of origin shal l mean the locali ty f rom which the biological or genetic m ater i al i s acc es sed . 129. Sample shall mean any distinct part of biological or genetic material or resource including its derivatives, compounds, extracts, progeny, m o di fi ed o r u nm o di fi ed . 1.30. Research Data shall mean all recorded information generated during the implementation of this Memorandum of Agreement. 13 1. Technology shaU mean technical information, product standards, know-how , formulation system, standards and data, equipment, procedures for the manufacture, and sales marketing program for the deUvery of said product under thi s M emorandum of A greement 13 2. Technology transfer shaU mean the movement of or f low of technical knowledge, data, design , prototypes, material s, inventions, sof tware, an d o r tr ade secr ets fr o m one purpose to another purpose. 133. Third party shaU mean any person, company, organization and or any other legal entity that the parties to this Memorandum of Agreement may consult , coUaborate 7 89Kenya Subsidiary Legislati on, 2025 with, and enter into an agreement with either severally or j ointed pursuant to the provisions of this Memorandum of Agreement or in the discharge of the party ’s obligations as set out here. 134. User shal l mean the recipient of the biological material or genetic resources and their derivatives including associated knowledge. For all purposes and intent XXXXXXXXXX , XXXXXXXXXX , XXXXXXXXXX WUHS, shaU be the Users under thi s M emorandum of Agreement . A R T I C L E 2 - SC O PE Scope of what is accessed and utilized. A R T I C L E 3 - O B JE C T I V E S The principal obj ectives of this Memorandum of Agreement a r e : 3.1. To contribute toward reali sation of the obj ectives of the Convention on Biological Diversity, biodiversity conservation, sustainable use and equitable share of resul tant benef its f rom utili zation of biodiversity among the stakeholders. 3.2. To enhance Kenya’s biodiversity conservation and management by understanding the taxonomy and ecology of xxxxxxxxxx and how biodiversity l i n k s w i th h eal th as it contributes to xxxxxxxxxx control a neglected disease through research, monitoring, and information dissemination. 33 . To provide a platform to promote technical capacity strengthening, scientifi c research and technology transfer between — 3.4. To contribute to an ef fi cient system or mechani sm of l inki ng in-si tu and ex-situ co nser v at i o n o f x x x x x x x x x x an d x x x x x x x x x x s . 3.5. To collaborate in executing, implementation of the proj ect xxxxxx in Kenya” (x is a copy of statement of work (annex I) and a project proposal (annex H). A R TI CL E 4 - IN Si r r Un ON A L OB L I GA TI ON S 4.1. Joint Partner obligations 4.1.1. The partners are to comply with the terms of this M emorandum of Agreement . 4.1.2. Develop relevant governance structures to operationahze th i s M em o r an du m o f Agreement including Standard Operating Procedures (SOPs) for implementing proj ects and engaging students under this Memorandum of Agreement . 4.13 . Undertake j oint resource mobilization and ensure that the grant wil l be used exclusively for approved objectives, activities, and budget items in accordance with the relevant f unding agreements. 4.1.4. Provide adequate proj ect location faci lities, local techni cal i nstal lati ons and other physical project fi Wework, as specifi ed in the project d oc u m en ts . 4.13 . Comply with all relevant domestic legislations and international obl igations defi ned in the M ulti lateral Environmental Agreements (M EA s) where K enya is party to (as provided in the Constitution of Kenya, Article 2 (5) (6) . 4 .1.6. Estabhsh a code of best practi ces on A ccess and Benefi t Sharing (ABS) value chain including setting up an ABS Intel lectual Property desk of fi ce to promote and f acil i tate R & D based A B S contri buti on to val ori zati on of genetic resources of Kenya. and Kenya. Kenya Subsidiary Legislat ion, 202579 0 Foreign partner institution obl igations 4.2.1. Provide Biological resource technical expertise in the j oint research proj ect 4.2.2. Identify and develop appropn ate technologies and buil d capaci ty for understanding of Kenya’sxxxxx pc and xxxxxxxxxx xx biodiversity through research and technology transfer 42 .3. Support taxonomic revision and characterization of xxxxxx xxxx tax a, w here n ecessar y . 4.2.4. Contribute to the development and implementation o f ef f ec t i v e x x x x x x x ecological moni toring programs through j oint f ieldwork t o enh an ce c o n tr o l an d management of —— 4.2.5. Ensure that al l biological specimens and data coUection in K enya under this M emorandum of A greement are suf ficiently and accurately labeled as per KW S and requirements, and are deposited in approved designated reposi tories. 42 .6. Develop a database in consultation with KWS for monitoring col lections value ex - si tu an d in si tu c on ser v at i o n . 42 .7. Provide a l ist and dupl icate specimens and database of previously col lected biological material s f rom Kenya. 42 .8. Support digi tization of 4.2.9. Support the K enyan partners to establ ish capacity f o r technical experti se and technology transfer 4.2.10. Support outreach programs that wi l l contnbute to conservation, management and sustainable util ization of Kenya’s 4.2.11. Contribute to the development of monitoring tools, systems and procedures for collections m compl iance with PIC, M T A an d M A T . 4 2 . chain linking biodiversity col lections at XXXXXXXXXX . through — biodiversity ecological 42 .12. Tram Kenyans in 4 .3 . Obligations of Kenyan partner institution 4.3.1. Obligations of local partner 4 .3 .1 .1 . C oo r d i n ate ac t i v i t i es Kenya” R ev i ew an d estab l i sh ex - si t u co l l ec t i o n s o f x x x x x x x x x x s and x x x x x x x x x x s including but not l imi ted to l iving li braries of xxxxxxxxxxs and x x x x x x x x x x s based on code of best practices at XXXXXXXXXX (PIC, M AT , MTA ) in compl iance with Nagoya Protocol . Together with partners, review and update biological i n f o rm at i o n o n xxxxxxxxxxs and xxxxxxxxxx fauna in K enya. Develop a database in consultation with KW S for moni toring co l l ec t i o n s v al u e chain l inki ng ex-situ and in situ conservation. Ensure that the resultant benef i ts arising f rom this proj ect are used in l ine with Nagoya Protocol Article 9 and aU the pertinent international l aw s . Together with the other partners participate in the proposed research on the — 4 .3 .12 . 4 .3 .1 .3 . 4 .3 .1 .4 . 4 .3 .1 .5 . 4 .3 .1.6 . Kenya Subsidiary Legislation, 2025 7 9 1 4.3.1.7. In part nership with partner institutions build capacity for — biodiversity resource managers and local commumties in f ield ecological su r v ey s . 4.3.1.8. Supervise and/or co-supervise MSc, PhD and Postdocs students with facul ty ad v i so rs o f 43 .1.9. Develop uptake feedback pathway mechanism for R& D as per the Nagoya Protocol , A rti cles 16 to 19 . 4.3.1.10.Together with approved data sharing policies. 4.3.1.11.Jointly develop outreach programs that wi ll contri bute to conservation, management and sustainable util ization of K enya’s 43 2 . Obligations of provider 4.33 .1. Develop guidel ines for PIC, MA T , MTA , and outreach m ater i al s t o c r eate stakeholder awareness for ef fective implementation of thi s proj ect in line with the Laws of Kenya and the Nagoya Protocol . 4 .3.23 . Develop a database in consul tation with value chain li nking ex-situ and in situ conservation. I to use reasonable ef forts to comply and enforce users adherence to relevant permitting processes in line w i th th e E n v i r o nm en tal M anagement and Coordmation Act (EM CA , 2015) , Wi ldlife (Conservati on and M anagement) Act 2013, Science Technology and Innovation A ct 20 12 and aU the other Laws of Kenya. 4 .3 .2 .4 . E nsure that resul tant benef i ts ar e used in li ne with Nagoya Protocol Art icle 9 and all the pertinent international laws. 43 .2.5. Act as link between proj ect partners and local comm uni t ies, w hi le at the sam e time support the indigenous local community govern ance ABS through grant of PI C . 4.3.2.6. Together with the other partners participate in the proposed research proj ect digi tize and avai l biodiversi ty data as per the biodiversity . for monitoring coOections 4 3 .2 3 . W ork w i th 43 3 .7. Develop uptake feedback pathway mechanism for Pr o to co l A r t i c l e 16 to 19 •R& D as per Nagoya 4.3.2.8. Bui ld capacity of participating institutions through outreach programs on access to the country ’s xxxxxxxxxx and xxxxxxxxxx biological resource requirements A C C E SS T O G E N E T I C R E S O U R C E S A N D A SSO C I A T E DA R T I C L E 5 K N O W L E D G E K enya has sovereign rights over its natural resources where access and user rights are subj ect to international obl igations where Kenya is party to, and national legi slations. In the event that the parties seek to access biological materials and genetic resources, derivatives, progeny , extracts, geneti c in f o rm at i o n an d assoc i ated knowledge held in situ both in protected areas and outside protected areas in pursuance to this Memorandum of Agreement, prior informed c o n sen t an d material transfer agreements shall be executed by all relevant providers and users in accordance with al l appl icable laws. 5 .1 . 5 3 . Kenya Subsidiary Legislation, 20257 92 partner will make existing electronic inventory records o f al l biological materials of Kenyan origin under their custody av ai lab l e t o th e Government of Kenya through partner agrees to provide duplicate genetic resources specimens, derivatives and database in their custody collected during this proj ect and in previous undertakings to the Government of Kenya through designated repositories in Kenya. All access and transfer of biological material , resources, derivatives, progeny and associated information shal l be subject to a Materials Transfer Agreement (MTA) (a copy of which is attached to this Memorandum of A greement as Annex XX ) between provider and users as defi ned in this Memorandum of A greement . A H accessed and transfer of biological material s, resources, an d d er i v at i v es sh al l be subject to an MTA between Provider, and the designated recipient repositories. The biological materials, resources, their derivatives, progeny , products and associated information shall remain the property of the Government of Kenya. AU specimens collected from the wUd, including accessions f ro m ex - si t u specimens of Kenyan origin shal l be deposited in designated repository resource centres including gene banks and data bases. In this respect, this Memorandum of Agreement is the M AT for the proj ect titled - in Kenya” , and shal l form the basis of Provider granting a Pr i o r Inf ormed Consent (PIC) for the proj ect . When biological materials are accessed outside a protected area , K W S w i ll provide a PIC j ointly with relevant stakeholders as provided under the Wi ldli fe Conservation and Management Act of 2013, and KWS is the competent authori ty for granting of PIC on wildli fe resources within Kenya u n der th e W i ld l i f e A c t . 5.10. Databases of al l specimens accessed, transferred and util ized wil l be developed and kept in dupl icate by the parties for tracking, monitoring and evaluation, repository and transfer of biological r eso u r ce s f ro m th e ex si t u co l lec t i o n s b ased o n th e in strum ents of PIC , M A T and MTA as per the L aws of Kenya. 5.12. Given that the user partner msti tutions to this Agreement- previously accessed Kenya’s biological resources for u t i l iz a t i o n i n v ar i ou s projects and purposes, by signing this Agreement and the users providing an inventory of records of aU activities and aU col lected biological resources, progeny, derivatives and associated information, the resource provider wi ll release the users, and assume to have compl ied with CBD and Nagoya Protocol , and through appropriate MTA, transfer the biological resources to the nati onal designated repositones. ARTICLE 6 - INTELLECTUAL PROPERTY RI GHTS AND PROTECTION Project implementation Committee wi ll establish an intel lectual property (IP) technical commi ttee with clear TORs for M anagement of the IP rights resulti ng f rom undertaking the Proj ect imder thi s M OA . The Project implementation Committee wil l undertake IP audi t before, duri ng and towards the end of the proj ect to show the basel ine and progress of existing and 5 .3 . T h e an d Pr ov i der . 5 .4 . 5 .5 . 5 .6 . 5 .7 . 5 .8 . 5 .9 . i 5.11. Guidelines shall be developed for h av e 6 .1 . 6 2 . Kenya Subsidiary Legislat ion, 2025 7 9 3 generated intellectual property. All generated and potential IP wil l be recorded in special notebooks and aU parties to the IP generated wil l sign specifi c IP agreements as per the standard operating procedures. AU partner insti tutions wiU submit their IP poUcies to the Proj ect M anagement Of fi ce and harmonized appropriately under this M emorandum of Agreement . The accessed biological and geneti c resources shal l remain the property of the Government of Kenya and aU voucher specimen duplicates wil l be deposited in designated repositories at XXXXXXXXXX and other designated repositories as per the established standards in conf ormi ty with the Nagoya Protocol instruments of PI C , M A T and M T A . The users wiU provide and keep clear records of biological and genetic resources, progeny , derivatives, products and associated inf ormation with potential I P before commercialization that wiU be negotiated between the users and provider under this Memorandum of Agreement for further development. The partners shal l periodicaUy review the results of j oint research proj ects to determine if any research findings including processes an d m eth od s co n st i t u te intellectual property and determine which inteUecmal property i s subj ect of legal protection. In consultation with aU the other partners, when fi l ing for protection and administration of IP ari sing fi n m research under this M emorandum of A greement and appUcation for IP rights wiU be accompanied by PIC, A ccess permit and voucher specimen reference. Transfer of generated IP rights by partner to new ownership wUl be subj ect to authorization by the provider and consultations by all partners under this M emorandum of Agreement . Technology j ointly developed and owned shal l not be transferred to a third party without the written consent of all parties. Intellectual property generated f rom the proj ect shal l be j ointly appl ied for and remain the j oint property of the part ners, with any revenues arising f rom commercialization of the products being equitably shared (as provided in Article- — of thi s M emorandum of A greement on Benefi ts Sharing) . Prior to any disclosure of proprietary information by any partner concerning specifi c aspects of thi s col laboration the part ners shall execute a separate Confi dential i ty A greement . Any decision relating to the commercial exploitation or to the manner of disposal of the intellectual property right shal l be made j ointly by the parties taking into consideration the inteUecmal property poUcies of each instimtion in parti cular the r o l e o f th e i nv en to r . Material for pubUcation or presentation arising from the proj ect shaU be submitted for clearance by the Proj ect Implementation Committee t o en sur e th at n o inventions or innovations or discoveries are publ ished prior to protection by applicable inteUecmal property laws or by trade secret. In aU activiti es including scienti fi c pubUcations resul ting f rom the proj ect including scienti fi c papers, reports, books and proceedings of conf erences, seminars, workshops and exhibitions wUl be authored j oint ly as appropriate to 6 .3 . 6 .4 . 6 .5 . 6 .6 . 6 .7 . 6 .8 . 6 .9 . 6 .10 . 6 .1 1 . 6 .12 . 6 .13 . 6 .14 . Kenya Subsidiary Legislation, 20257 94 ref lect w here the relevant contri butions have been made and in so doing quoting the names of authors and the part ners. Such acknowledgement sh al l in c l u de b u t not be limited to display in equal prominence of the f ul l names and symbols or logos of aU institutions including the donor. 6.15. Al l the parties herein agree to respect rights of indigenous knowledge holders and shal l negotiate with particular indigenous communities should any indigenous knowledge be used for any purpose in this proj ect and PIC granted by the said c om m un i t i es . 6.16. Proj ect Implementation committee will develop procedures for data and publication access as outlined in the SOPs. Proj ect Implementation Committee wil l classify data deemed as restricted and non-restricted establ ishing access procedures through an Information Transfer Agreement. 6.17. Responsibility for expenses relating to registration, ad m i n i str at i on an d f ur th er development and exploitation of the invention (including f un ds to th e in v en to r s to carry out further work to bring the invention to a stage where it can be commercially exploited, researching for commercial outlets, advertising expenses, and fees for patent advocates) wlU be agreed upon by aU parties. A RT I CL E 7 - TRA N SFER T O TH I RD PA R T IES A partner in this proj ect may transfer biological resources, derivatives, progeny , products, compounds, extracts and associated information to third parties onl y af ter consultation with all the other partners, and a w r i t t en co nsen t f ro m th e Provider (KW S) . Sub-contractors and third parties shall enter into legal ly binding undertakings with the part ners before they can handle any resources and/or f unctions in the proj ect . Such agreements wlU be annexed to and wlU form part of thi s M em orandum of Agreement . The partners may assign, transfer or otherwise dispose, in whole or in part , to third parties any rights or obligations under this M emorandum of Agreement af ter a written permission is sought and procured by al l the parties to thi s M emorandum of A greement . The Recipient shal l ensure that the col lection, storage, transf er , uti l izati on , disposal and exportation of the genetic resources complies with al l appli cable Laws of Kenya on the protection of human health and the env ironm ent , on tax es, on customs and any other concern. The Recipient shall indemnify and keep the provider its trustees, appointees, employees, agents and the State harmless from any claim, action and damage or cost deriving f rom or in connection with the Recipient’s acquisition, use, storage or disposal of the material s. A R T I C L E 8 - B E N E F I T S SH A R I N G Benef its resulting f rom uti l ization of biological resources by aU partners wil l be used in accordance with the CBD and Nagoya Protocol an d in l i n e w i th th e Consti tuti on of K enya and the domesti c legislati ons su ch as W i ld l i f e Conservati on and M anagement Act 2013 and EM C A 2015. Partners shal l take inventory of al l potenti al and derived benefi ts guided by the IP audit reports and develop agreeable benefi t sharing plan. 7 .1 . 7 2 . 1 3 . 7 .4 . 7 .5 . 8 .1 . 8 .2 . Kenya Subsidiary Legislation, 2025 7 95 8 3 . Benefi ts shall include both monetary and non-monetary on the R& D value chain , which wil l include both academic and commercial steps. These benefi ts w il l be shared m accordance with the benefi ts sharing plan (provided in Annex V) and uti lized as stipulated in the Nagoya Protocol Article 9 . The monetary benefi t arising from IP commerciahzation shal l include upfro nt, milestones and royalties as determined case by case. Copyrights shall be based on 15% ro yal ty payments. Others will attract minimum of 10%. Payment wil l be annual based on submission audit report. In the event of development and commercialization of a technology ft om the utilization of the accesŝ biological resources, the pro viders wil l be given access and use of the technology and where possible, one of the production sites to be at the country of origin. The venture to be owned on a 50 :50 basis and i n the event of sale of ownership rights by the user, the country of origin is given priori ty. The benefi ts-sharing plan shall consider the communities l iving adj acent to the pro ject sites and their indigenous knowledge. A R TI CL E 9 - C ON F ID EN T I A L IT Y All research, development and commercial ization information created by parties to this Memorandum of Agreement shal l be considered confi dential information, subject to express wntten agreement to the contrary. Where the release of research and development information created pursuant to this Memorandum of Agreement is required for the pro curement of permits, licenses and other appro vals necessary for the effective ex ec u t i o n o f th i s Memorandum of Agreement, or otherwise to comply with national legislation, regulations and pohcies the users shal l: (a) Pro vide such information as requested with the express stipulation that the sam e shal l be considered confi denti al , (b) Supply such information as part of compliance mechanisms in n at io n al p r oce sses . 8 .4 . 8 .5 . 8 .6 . 9 .1 . 9 .2 . 9 .3 . Research and development information regardmg discontinued act i v i t i es th at h av e not resulted in the development of a commercial ly applicable pro duct to thi s Memorandum of Agreement shall be placed in the public dom ai n af ter a minimum of fi ve (5) years or in accordance to the Laws of Kenya. Aspects of publications will be handled as per article 10.9 on adm i ni str at i o n . Partners wiU execute confi dential ity agreement as per SO P . ARTI CL E 10 - ADMINI STRA TION OF Tffl S MEM ORANDUM OF A G R E E M E N T 10 .1 . 9 .4 . The part ies wi l l establ ish coordination mechanisms for implementation of thi s Memorandum of Agreement and the various pro jects. Parties wiU establish pro j ect implementation committee w i th c l ear T O R s . This pro j ect implementation committee shal l be constituted as per the pro j ect document. The proj ect implementation committee wfi l be drawn from the partner institutions and will comprise the Principal Investigators (Pi s) . Pro ject implementation committee wiU develop the Standard Operating Procedures (SOPs) in line with the pro jects objectives and the Nagoya Pro tocol . 10 .2 . 10 3 . 10 .4 . Kenya Subsidiary Legislation, 20257 9 6 10.5. Research performed under this Memorandum of Agreement shal l be in accordance with the “statement of work” (Annex I), and the SOPs. 10.6. Meetings, decision-making and monitoring will be done by the project implementation committee The project wUl have an inception workshop to be held at the beginning of the project and a closing workshop at the end of the project as per the approved work plan ‘Targeted products meetings’ will be held ad hoc whenever specific-product- oriented eff orts yield promising and potentially exploitable r esul ts . 10.9. Decisions on scienti fi c, technical and organizational aspects of the project will be handled by project implementation committee based on the approved work plans. There will be frequent meetings to review progress on R& D related to the project . 10.10. Final decisions on intellectual property protection and commercialization will be handled by the project implementation committee who will prepare a report and present it to the providers. 10.11. The inventory of project equipment boû t under the grant shall be establ ished and will remain in the custody of the host mstitution. ARTI CLE 11 - REPORTS 10 .7 . 10 .8 . 11.1. Research Reports: Ai l research activities undertaken shal l be recorded in of fi ci al research and fi eld notebooks. (a) (b) All participating researchers shall prepare research reports as per the SOPs on a quarterly basis. 11.2. Payment reports This will be as defi ned under the benefi t sharing arrangement. 113 . Copyright reports This wil l be as defi ned under the benefi t sharing arrangement . 11.4 . R ecords An inventory of all the relevant records shall be identifi ed. Records shall include among others, permits, licenses, datab ase . The part ners will ascertain that the project records are safely kept and available for inspection, external and internal audit. The project records shall consist of scientifi c reports, legal , ethics and IP reports, letters, memos, fi nancial reports and part nership reports, minutes of aU meetings, among other proj ect documents. After expiry of the project, the records shall be kept f or a m inim um of fi ve years, subject to the laws of Kenya. (a) (b) (c) (d) (e) Records based on sales to be well kept by the user and availed to provider request. The records will be kept for a minimum period of f ive (5) (f) u po n years after proj ect completion 7 9 7Kenya Subsidiary Legislation, 2025 11.5 . V eri fi cati on of records The users agree to permit identifi ed auditor by the provider to examine then- books and records f ro m time to time during their ordinary b u sin ess h ou r s . 11.6. Donor narrative and fi nancial reports Both narrative and fi nancial reports shal l be prepared according to institutional fi nancial arrangements and the donor requirements. 11.7. Declaration by the users to the provider (a) The users shall declare reports to the provider on fi nancial positi on, technology transfer, IP, accruing IP royalti es, dividends, income, pertinent investments, and distributi on of partner shares, among others, derived f rom the utilizati on of the biological resources accessed under this project, (b) Farmers commit to avail ing all the records perti nent to the proj ect for inspecti on. 11.8. Legal , ethical and IP Reports The partners wUl prepare periodic legal , ethical and IP reports on a quarterly basis and presented to tdl the parti es. 11.9. Final Report (a) There wOl be a fi nal report within three months of the proj ect completi on under this M emorandum of A greement , (b) A fi nal report shal l be prepared at the expiry of the M em orandum of A greement . ARTICLE 12 - SPECI FIC SUBSIDIARY A GREEM ENT S 12.1. Without prej udice to their respecti ve role and obligati on under this Memorandum of Agreement, the parti es may enter into further agreements to give ef fect to any provisions of this Memorandum of Agreement . 12.2. Any agreement or agreements entered into shall specify at least the following detai l s (a) Namre of agreement , (b) Objecti ves and durati on of parti cular acti viti es, (c) The terms of reference of acti viti es to be undertaken by each part y . (d) All fi nancial terms and conditi ons applicable to each party . (e) Any other provision as may be applicable in the specifi c circumstances. 123 . Each subsidiary agreement shall be in English and shall be signed by the chief executi ve offi cers of the parti es. 12.4. The subsidi ary agreements shall be annexed to thi s M emorandum of Agreement and may be reviewed at specifi c intervals as specifi c in such agreements. A RT I CL E 13 - L IM I TA T I ON S 13.1. This Memorandum of Agreement does not in any way restrict part ies from part icipating in any similar acti viti es with other organizations or individuals. 7 9 8 Kenya Subsidiary Legislati on, 2025 13^ . This Memorandum of Agreement and annexes constitute the internal agreement between the parties and no modifi cati on or additi on wUl be valid unless signed by the parti es and appended to this Memorandum of Agreement. A R T I CL E 14 - N O L EGA L PA R TN ER SH I P Nothing herein contained shall consti tute or be construed to be or create a legal partnership or agency between the parti es. Neither party shall have the power or right to act as an agent or representati ve of the other party, or transact business or incur obhgati on in the nam e of the other party or for the other party or to pledge the credit of the other party or any j oint cr ed i t . Where a party acts as an agent or representati ves of the other party in contraventi on of the preventi on of sub clause, the other party shal l not be held liable of any such Acts or representati on. A R T I C L E 15 - A SSI G N M E N T This Memorandum of Agreement is speci fi c to the parti es and no party shall have the right to assign or otherwise dispose of the benef its of this Memorandum of Agreement. A R TI CL E 16 - A CK N OW L EDG EM ENT A N D COM M U N I CA T I ON Each party agrees to explicitly acknowledge the other party ’s support and logo provided pursuits to this Memorandum of Agreement on all media ann ou nc em en ts , documentations, programs, reports or publicati ons. A R TI CL E 17 - M ON I T ORI N G A N D EV A L U A T I ON Sh al l be ex ec u ted : (a) In reference to arti cle on article 10 on administrati on, (b) In compliance with Nagoya protocol . Article 17, o n th e r o l e o f C h ec k P o in ts in moni toring and evaluati on A RTI CL E 18 - IN SUR A N CE A N D IN D EM I N I H CA T I ON Each party shal l be solely responsible for payment of any and aU claims of loss personal inj ury, death, property damage, or otherwise or arising f rom any act , or mi ssion of i ts employers or agents in connecti on with performance of this M emorandum of A greement . A RTI CL E 19 - D UR A T I ON OF M E M ORA N D UM OF A GREEM EN T 19.1. This Memorandum of Agreement will come into ef fect on the ef fecti ve date (date of the last signature to this Memorandum of Agreement) and, subj ect to the provision of this sub- clause, wOl subsist for at least ten years. The parti es wi ll review the Memorandum of Agreement and progress duri ng annual meetings to determine whether it should be revised, ren ew ed o r terminated, and defi ne the speci fi c obligati ons, inputs an d ac t i v i ti es to be delivered by each party in the succeeding year. The parti es shal l alternately take the lead convening those meetings through mutual ly acceptable communicati on mediums, including physical meeti ngs, telephone conferences an d em ai l discussions as may be appropriate. 193 . Either party may terminate the Memorandum of Agreement by giving 90 days prior written noti ce to the other parti es 14 .1 . 14 3 . 14 .3 . 19 3 . Kenya Subsidi ary Legislat ion, 2025 7 9 9 A R T I C L E 2 0 - A M E N D M E N T The M emorandum of Agreement may be amended f rom time to time by mutual consent of the parties. Any such amendments shal l be in writing and shall be signed on behal f of each party by the Chief Executive Of ficer of that party . A R T I C L E 2 2 - A P PL I C A B L E L A W This Memorandum of Agreement shal l be govern ed by and co nstr u ed in ac co r dan ce w i th the Laws of Kenya. A R T I C L E 2 3 - D I SPU T E R E S O L U T I O N In the event of any dispute arising between the parties touching on any provision of thi s Memorandum of Agreement, each party shall use their best endeavors in good faith to resolve such disputes. Any dispute that cannot be amicably settled can only bring a suit or make a claim against the other, can be brought exclusively in the agreed arbi tral tribimal b ased o n in tern at i o n al stan dar ds . A R T I C L E 24 - F O R C E M A JE U R E 24 .1 . Any party shal l not be l iable to the other for any delay or any performance of its obl igations under thi s M emorandum of Agreement ari sing f rom any cause beyond i t s r easo n ab l e c on tr o l un l ess co n c l u si v e ev i den ce to the contrary is provided. The party claiming the Force Majeure event shal l promptly notify the other party in writing of the reasons for the delay or stoppage, and die likely duration of such delay or stoppage, and shal l take aU reasonable steps to overcome the delay or stoppage. For the purpose of thi s agreement, a Force M aj eure sh al l m ean c i r c u m stan ces beyond the reasonable control of the party af fected there by without prej udice to the general ity of the foregoing, the fol lowing shall be regarded as such c ir cu m stan ces : (a) A ct of God, explosion, l ightning, f lood, tempest, fi re , or acci dent ; y (b) W ar , (whether war be declared or not) , invasion, act of foreign enemies; (c) Outbreak s of hostil i ti es, ri ot , ci v il disturbance, act of terrori sm ; (d) A ct , restri ctions, regulations, by-laws, ref xxxxxxxxxxl s to grant any li cense or permission, prohibi tions or measures of any kind on the part of any governmental authori ty ; (e) Import or export regulation or embargoes; (f ) Power fai lure of whatever nature, fai lure of telecommunications l ines, f ail ure or breakdowns of machinery or vehi cles; (g) Thef t, mali cious damage, str ike, lock out , or industrial action of any kind (whether involving employees of the parties or thi rd party); (h) Any clause or ci rcumstances whatsoever beyond the parties reasonable co n tr o l , (i) Neither of the parties shal l be entitl ed to rel ief under this clause in any circumstances where it has caused or substantial ly contributed to any delay or fai lure in the performance of its obligations by any defaul t on its part . 24 .2 . 24 3 . Kenya Subsidiary Legislation, 202580 0 Signatories and witnesses Signing In Witness whereof , this Memorandum of Agreement has been signed in triplicate by the following duly authorized persons on behalf of the Pr o v i d er N am e : D ir ec to r G en er al W i tn ess A N N E X E S Annex I - Statement of woric for project titled “Xxxxxxxxxx-related stu d i es o f and control xxxxxxxxxx in K enya” (attached) Annex n - PIC for proj ect on biological resources fi o m Kenya (attached) A nnex I Q - MTA for transfer of biological resources ft om Kenya through the proj ect (attached) Annex IV - TORs for Project Executive Committee, Proj ect Management Of fice, Project Steeri ng Commi ttee; 1. The role of contact person shal l be: (a) Coordination of project activities (b) Management of j oint intellectual property (c) Compilation of interim reports (d) CompOation of fi nal reports to be shared among the parties within six (6) months of the compilation of fi eld and laboratory work. 2. The parties shal l appoint a technical committee to undertake the foll owing role: (a) Protect oversight (b) Proj ect pol icy di rectives (c) Relevant and approvals of projects/ work plans/budgets (d) Monitori ng and evaluation of the Memorandum of Agreement/ activities (e) Resource mobilization. Annex V - Benefi ts sharing Plan (attached) Signature: Signature; Kenya Subsidiary Legislation, 2025 80 1 SI X TH SCH E D UL E (regulat ion 21) M A TERIAL TRAN SFER A GREEMENT 1 .0 . Pr eam b l e Whereas the sovereign rights over biodiversity are vested in the State; Aware of the letter and the spirit of the 1973 Convention on I nternat ional T rade i n Endangered Species of Wild Fauna and Flora (CITES), the 1992 Convention Biological Diversity (CBD), Nagoya Protocol (2010), the 2004 International Treaty on Plant Genetic Resources for Food and Agriculture, Biological and Toxins Weapon Convention (BTWC) 1972 UN resolution 154;Q ̂2004), -Recognizing that Kenyan Government has put in place various legislative for sustainable util ization and conservation of biodiversity such as; the Consti tution of Kenya (2010), Environmental Management Co-ordination Act (EM CA ) 1999, the Wildlife (conservation and Management) Act, Amendment 1989 , the Forest A ct of 2005, Industrial Property Act, 2001, Plants and Seed Varieties Act, Cap 326, Kenya Agriculture Research Act, 2012, the Environmental M anagement and Coordination (Conservation of Biological Diversity and I lesources, A ccess Genetic Resources and Benefit Sharing),Regulations 2006! Noting the diversity, vari ed ori gins and inherent value of iKenya’s geneti c -resources and their contri bution to environmental heal th and socio-economic development. Acknowledging: The ri ghts of Iqcal cornmunities to associ ated tradi ti onal knowledge on biological resources Md its contri bution to science, technology and innovati on : o n m e a s u r e s t o The parties hereby agree ̂as fol lows: 2.0. Parties to the Agreement 2.1. This Materi al Transfer Agreement hereinaf ter ,referred to as the agreement is the official document for transfer of blolpgicaiygenetic m ateri al s f o r Kenya. 2.2. The party(ies) to the, agreement shall be recognised legal enti ties. 2 .3 . 'Pri v ate resource owners, international resê h organizations an d nongovermnental organi^ ons shal l become party through relev ant nati onal agencies. 2.4. -This agreement is between: Provi der names of authori zed of ficers) A n d .(inseirf legal contacts of providing institution. Recipient ■institution, names of authorized officers) 3.0. Terms and conditions of this Agreement 3;1. The purpose and.obj ectives: State the purpose whether: Academic, Research or commercial, taxonomy , collection, and expected .outputs; include the title of the proj ect and the . ab str ac t (inseij legal contacts of receiving Kenya Subsidiary Legislation, 2025802 3.1.1. Obj ecti ves Indicate type of materi al , sources, and GPS points 3.1.2. Provide documentary evidence of the fol lowing (A ttach as annex): (a) Depositi on of duplicate specimen in designated repository center (b) PIC and M AT 3.13 . Provide associated tradi ti onal knowledge and source (if any) 4.0. Rights and obligati ons of providers and recipients 4.1. Both the provider and the recipient shall notify the NEM A and any other relevant lead agency on the MTA implementati on,materi al transf er to T hi rd party, any discoveri es and further use of the materi al through reports 4.2. TK, informati on and data disclosed and or generated during access to the GR shal l not be disclosed to thi rd parti es withoutconsent of the provider . 4.3. Confidenti al or propri etary GR informati on shall not be discl osed unl ess the informati on is in the public domain or is disclosedin public interest . 4.4. Rights and obl igati ons of the provider The provider retains ownership of the geneti c materi al i ncluding any materi al contained or incorporated in modifi cati ons. The provider may repatri ate genetic resources held by recipient with adequate pri or wri tten noti ce. The provider also retains ri ghts to any intellectual property it owns in geneti c resource . The provider retains the ri ght to access, audit and moni tor the use and applicati on of the geneti c materi al provided under t h i s M T A . No ri ghts under any intellectual property of Kenya or ri ghts in any other materi al or confi denti al inf ormati on provided by the Kenyan to the recipient under this agreement is granted or implied as a r esu l t o f providing this materi al to the recipient, other than asexpressly set forth h ere in . 4 3 . Rights and obligati ons of the recipient The Recipient shall use the genetic resource(s) for the purpose stated in this agreement only The Recipient is responsible for ensuri ng that all permits requi red for the movement of the materi al are obtained and that suf fi cient proof of such permits is provided to the provider whenever required to provide such proof . In no circumstances shal l the recipient col lect materi als in such a way that adversely af fects the environment or in any way alter the geneti c diversity of the source materi al (a) (b) (c) (d) (e) (a) (b) (c) Kenya Subsidiary Legislat ion, 2025 80 3 (d) No commercializati on shal l take place without notice and a negoti ated agreement with the provider . In the event of commercial ization whether by the recipient, i ts se r v an ts and or agent or any party acting under it regardless o f w hether th er e was an act or omission on the part of the recipient resulting in the use and commercial isati on of the GR without re- negoti ati on f o r th e commercial li cense agreement the recipient wi ll pay 50% of the gross income arising f rom the GR. In any case the provider sh al l bec o m e th e duly recognised supplier of the geneti c resource. The K enya Government shall have unrestricted access t o th e technologies and processes developed from the access an d use o f th e G R . (e) (f) (g) the event of commercialisati on, the recipient and provider are enj oined in ownership of patents of inventi ons arising f rom util izati on of geneti c resources accessed as agreed . The GR obtained under this agreement shall only be transferred by the recipient to a third party with prior written authori zation f r o m th e provider and MTA between the recipient and the thi rd par ty . The recipient shal l indemni fy and keep provider indemnif ied fr om any claim , acti on, and damage or cost derivmg f rom or in c o nn ec ti on w i th the recipient ’s use of the GR. The recipient may fi le patent application(s) claiming rights over its inventi ons made by recipient through the use of GR or m o d i fi ca ti o n s and in the event of technology transfer to thi rd party o r commerciali zati on, the recipient shal l negoti ate with the provider prior t o su ch use . 5.0. Repatriation of geneti c resources f rom foreign deposi tories 5 .1. D ue to nati onal in terests such as f ood or env ir onm ental securi ty , the Govermnent of Kenya may requi re the return of the remamingGR as required by the circumstances and recipient shal l return such GR , to such i nsti m t ion as may be designated by NEM A without any condition. 5.2. The recipient shall use the geneti c resource and/or asso c i ated tr ad i ti o n al knowledge for the purpose(s) contained m thi s-agreement and/ o r c on t i n u e to keep the geneti c resource in safe custody in accordance w i th stan dar d procedures and practi ce. 6.0. Terminati on of agreement 6.1. This agreement i s binding throughout the exi stence o f th e acc e ssed G R . 62 . On terminati on of this agreement, the recipient shal l destroy (unless requested by provider to remrn the said remaining material) and shall provide proof nnmediately to the provider 6.3. Any procedurally duplicated GR/biological material sh al l su r v i v e t h e l i fet i m e of thi s agreement and should be freely accessible tothe Kenya government and the provider upon request . (h) (i ) G) 7.0. Warranty 7.1. The Provider makes no warranti es as to the safety o f o r ti t l e t o th e G R material , nor as to the accuracy or correcmess of any informati on provided Kenya Subsidiary Legislati on, 2025804 with the Material . Neither does it make any warranties as to the quali ty , viability, or purity (genetic or mechanical) of the M aterl^ being f urnished. 7.2. The phytosanitary condition of the Material is wp rm ted .o.nly as described in any attached phytosanitary certifi cate. T he R^ ipient assum es M l responsibil ity for complying with the recipient nM on’,s..quaranti ne regulations and rules ̂ to import or release of geneticmaterial . 8.0. Appl icable laws The applicable law shal l be the domesti cating national daws ,of Kenya, the relevant provisions of the Nagoya protocol , ̂md, whennecessary forM te rpre tati on, the deci sions of the NE M A . 9.0. Di spute resoluti on Any dispute,arising from this Agreeinentshal l b^ resolved in the followii^ isanaer: (a) Amicable dispute settlement: The p^ es.shall attempt in ̂ oqd faith to re solye t)ie dispute by negoti .ation. (b) Mediati on: I f the dispute is not resolved ;hy -negoti ati on, ..the parti es ̂njay choose mediati on through a neutrd jhi rd7party .mpdi^ r , to be rPiutual l y agrê . (c) Arbitrati on: .If tlje dispute has not been .̂ eQied tby segpti ati on p.r m.ê atipnj any part y may submit the dispute fo r mbitHUion jmder the .i^ bitrati on Act No. 4 of 199S of .laws of Kenya and .in accp.rdapce .w ith -th.e,procedure laid down in.part l .of Annex H of the Ppnyenti on on.BiolpgiQal ’P iversity . 10.0. Fo.rce maj eure 10.1. ’Neither ..part y shall be liable to the ..pther party <or .any delay ,or npa- .conform ance of ..its obligati ons .under this Agre eme.nM isj iig f rpm .apy .p lause .beyond its .reasonable cpntrol. including, ̂.bto p.pt tlimit̂ ito , .̂ y of th,e following: goyemment Act, war, fi re, droî t,jsxplosion, civi l ,cpmrpoti oiKor industrial disputes .pf a third party or impossibility of .pbto ining gas (.or electri city or materials. 10.2, The affected .party must pjrpmptly noti fy the .other .p arty inr\yritingj i.but in .n.o circumstances no late r than fo urt een days, of the cauto and.likply .durati on pf th e cau se . 103 . Such noti ce having 'been given, .the peif ormance pf .the aĴ ecjted (party ’s obligati ons, to the extent af fected by ,the cause, shall be,suspepded,d,uring.tlte period the cause persists. 10.4. Without prejudice to the above, the .af fected part must take all ree nable .measures to minimize the irnpact of any forc e majeure.pn the performance of ,its obligati ons under the Agreement and .to ensure,,as soon as prac,ti cable,.th e resumpti on of normal performance p f the obligati ons i^ ected ,by the fo rce maj euj e- •Jl .O. Notices Any noti ce pr other 4oc.um.ent fo be ̂ rved under this Agreement m ust ibe delivered -by '.hand or .sent by registered ,mai l or .byinte mati onal .cp.iirier service to be served:at !th,e addressps below : Kenya Subsidiary Legislat ion, 2025 80 5 Designat^ National-Authori ty Inser t the name of the Institution and the addr ess Competent Authority Insert the name of the Institution and the addr ess Pr o v i der ' Insert the name'of the Pf ovider (s) and the'address Recipient Inser t the name of the Insti tution and the addr ess A l l notices or documents shall be-deemed to have been' ser ved at th e date an d t im e of delivery of the said notices of documents to therecipient par ty . Signature/Acceptance ■ For pro vider Name and Signature of Head-of -institution Name and signature of Authoriziiiig officer For recipient- Name and-Signature of authorized offi cial - Name and signature of principal investigator Witnessed by M ade on the 17th M arch, 2025. A D EN D U A L E , Cabinet Secretary f or Environment, Climate Changej and Forestry . PRINTED AND PUfl U SHED BY THE GOVERNM ENT PRINTER, NAIROBI ^^̂ RARy ar ch ive

Environmental Management and Co-ordination (Access to Biological Resources and Benefit Sharing) (No. 2) Regulations, Legal Notice no. 68 of 2025 · Nelum