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The Covid 19 outbreak has impacted the world in so many ways.

Perhaps one of the most significant impacts is a re-evaluation of the entire approach to health, economics and social wellbeing.

Perhaps for the first time in several decades, the established mantra of more money, more stuff, and more efficiency are being challenged by the possibility that more health, more community and more resilience are preferable.

This global catastrophe brings the spotlight onto indigenous communities around the world for both reasons of concern; with these communities likely to feel the worst of the health impacts should the pandemic spread unabated; and for reasons of hope, with their traditions of sustainable, resilient, community focused approach that prioritizes oneness of the people with their environment, and their unique means of working with their environment to provide health, sustainability and wellbeing.

The Cook Islands is a small island state in the middle of the South Pacific Ocean, and we have a rich history of traditional knowledge including medicinal plants that were integral to the lives of our ancestors.

The Custodians of Biodiversity in the Cook Islands, the Koutu Nui, entered into a Nagoya Protocol compliant ABS agreement with myself to develop traditional medicine for treating injuries, years before the Nagoya Protocol was proposed or ratified.

This project has resulted in international patents, recognition and support from the UN and affiliated agencies, improved awareness and pride in our cultural and natural heritage and has led to the implementation of changes to our regulatory environment to ABS agreements and use of traditional medicines within and from the Cook Islands with two products being brought to market TeTika and TVATI that maximize the benefits to the Cook Islands.

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Under Pre European management of the political and social structure, the dominant form of governance was based on a system of led by the Ariki, the , and the taunga, the custodians of sacred and scientific knowledge that guided the voyages and settlement of . Between 30-40 generations ago, this system had connected the people of the Polynesian islands from in the north to in the south and a thousand islands in between.

The paramount chief known as Ariki, and a system of subordinate chiefs governed the Islands. The chiefs held social and supernatural power called Mana. The Koutu of the Ariki managed territories and the Taunga were adepts of particular arts (eg navigation, carving or healing) and spiritual matters, and also held Mana.

The Cook Islands was an integral component of the Polynesian Ariki system and featured in many of the great voyages of the ancestors, including the migrations to New Zealand

The control of the Ariki changed as the Cook Islands moved from British protectorate to New Zealand governance.

Whilst the Aronga Mana was officially preserved, with the Ariki represented in the , and the Koutu of all the Ariki represented by the Koutu Nui, however they no longer had the responsibilities of provision and governance under the new system, and were focused on preserving and promoting cultural heritage.

Unfortunately, at that time, traditional Maori medicine was not considered a heritage and had been illegal to procure or to provide for almost 100 years.

By the 1990s the lagoons had suffered overfishing, degradation and sporadic outbreaks of ciguatera poisoning. This combined with an increasing global awareness of conservation movements led to interest in marine reserves. There was widespread feeling that the government could not implement marine reserves without resentment and disobedience. A traditional practice called Raui was to be reintroduced as a means of protecting the lagoons. This is a traditional practice of marking out an area of productive land or lagoon and declaring it off limit for harvesting for a particular period.

This was simply made by decree and the population obeyed out of respect. By the 1970s the practice had ceased on Rarotonga as people would openly ignore the Raui and remove the markers. Although the foreshore and lagoons were now designated crown lands and controlled by Government, the community felt that only the Koutu Nui would have the power to implement Raui.

The population came to respect the process of community discussion instilled by the Koutu Nui and Raui was soon re-introduced on behalf of the people, rather than imposed upon them.

Cook Islands Medical Research CIMRAD And Development Group

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Towards Access and Benefit-Sharing Best Practice

Pacific Case Studies

There is no Law enforcing the Raui, just the Mana of the Koutu Nui. Today, the Raui remains in place and is one of the most successful volunteer marine conservation practices in the world.

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The success of the Koutu Nui in the implementation of the Raui led to their increased involvement in other matters of cultural importance, land tenure, environmental matters, marine resources, undersea resources, immigration and other issues. In 2017 an extension of Raui Report written and preparedtraditions Teby MaraeDr!Daniel Moana! Robinson, was declared, Senior recognized Lecturer, by theInstitute United of Nations Environmental as the worlds Studies, The University of New South Wales, Australia.largest protected Dr Robinson area, covering is also almost a Research 2 million square Associate km of Cookof Natural Islands Jus territory.tice.

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Cook Islands Medical Research CIMRAD And Development Group

! Healers and wheeler-dealers 9/04/11 10:41 AM 3"%%.,%'Q"?&',0'!";.5"#,%)' ! We Cook Islands Maori, like all Polynesians, are descended from a Warrior Race of navigators. One that navigated the Moana Nui O Kiva, the Pacific Ocean, and the prized possession of our people was the strength and bravery of our Toa, the knowledge of the taunga , and the Mana and leadership of our Ariki and the cohesion of the community under the Mataiapo and the Healers and wheeler-dealers Deborah Smith Koutu. April 9, 2011

The natural world provided stars and currents, the plants and the land and our ancestors developed solutions to our existential threats. This knowledge, passed on for generations, has survived despite the devastating impacts of disease and colonial rule on the population and traditions of the people. Our traditional methods of treating bone and soft tissue injuries aided our traditional warriors back on the battlefield,

The late President of the Koutu Nui TeTika Mataiapo Dorice Reid was initially skeptical about the benefits of permitting the research, as an active member of the world indigenous persons organisation, she was of the position that no indigenous peoples had a positive outcome from

Plant cures ... Bill Walsh and Graham Matheson monitor bone regeneration. Photo: Dallas Kilponen sharing their traditional knowledge.

Grassroots activists vie with corporations for ancient cures, writes Deborah Smith. She had herself navigated the pacific islands on the voyaging canoe Vaka Te Au O , with Graham Matheson lists his injuries matter-of-factly: ''I've broken my right ankle twice, my left ankle once. I've dislocated my right shoulder and torn lots of hamstrings. And I've had plenty of other injuries, like broken fingers.'' my sister as a cabin mate, and saw for herself the accuracy of the navigational knowledge. She was convinced that we would find that the knowledge was accurate, and that if we held the The Sydney doctor, biomedical engineer, researcher and company founder bears the scars of a passion for rugby. secrets to improving health of people, as beneficiaries of knowledge and technology from other And it is his experiences on the football field - or, more to the point, off it - that underpin his entrepreneurial drive. Hecultures, knows, as awe doctor had and an an obligation to investigate and develop our knowledge, so we too could athlete, how annoying it can be to have a broken bone prevent you from playing sport. ''If you break a bone we set it straight and we just wait for it to heal. There is no specific therapeutic agent able to fix it,'' he says. contribute to the health and wellbeing of others.

But within 100 metres of his home on Rarotonga, in the Cook Islands, there are four plants that have long been used by islanders in a traditional treatment - with apparent success - to help heal skin wounds and speed up the repair of bone fractures. ''I figured it was certainly worth looking at,'' he says. “I am convinced our ancestors were For thousands of years, the natural world has been the source of medicines. However, in recent years, conflicts scientists…they didnʼt randomly float over who has the right to commercialise and benefit from genetic resources and traditional knowledge have intensified. across the pacific hoping to hit an Basmati rice from India, the taro plant from Hawaii and rooibos tea in South Africa have been the focus of recent island, so I donʼt believe they biopiracy disputes between biodiversity-rich countries and cultures, and companies wanting to exploit this natural wealth. randomly threw a few plants together In Australia, controversy surrounded a recent application by the American cosmetic hoping to mend a bone” ! company Mary Kay to patent an extract of the Kakadu plum for use in a skin-care product, with some Aborigines worried it could prevent them using the fruit as bush Dorice Reid, head of the Cook Islands tucker or medicine. chiefs council, which approved the research. Photo: Cook Islands News Dorice Reid, the president of the Koutu Nui (council of chiefs) for the Cook Islands, says the chiefs were well aware of these issues when Matheson approached them in 2002 seeking permission to carry out scientific research on the plants.

''We know of other countries that have had a problem with research on traditional Healers and wheeler-dealers 9/04/11 10:41 AM medicines where permission was not requested, let alone granted,'' Reid, also known as Te Tika Mataiapo, says. He said Cook Islanders, with their high standard of living, were ''happy to avail ourselves of the rest of the world's technology'', such as mobile Matheson, whom she describes as ''one of our finest sons'', is a great example of Kakadu plums. phones and high-speed internet. someone who went about it ''the right way'' by seeking the chiefs' approval and involvementNow they had from a chance the outset. to see whether their traditional knowledge could help millions of other people, he said. ''So who were we to withhold our technology from the rest of the world if it could be of use?'' HavingHealers trainedand wheeler-dealers as doctor in Sydney on a scholarship at the University of NSW, Matheson came home armed with two very persuasive9/04/11 arguments 10:41 AM toTo overcome clinch the any deal, doubts there thewere chiefs his unique might haveacademic had. credentials, his plan to carry out his research at the University of NSW in collaboration with Cook Islands Medical Research CIMRAD And Development Group Professor Bill Walsh and to pay for it by working in a hospital. He said Cook Islanders, with their high standard of living, were ''happy to avail ourselves of the rest of the world's technology'', such as mobile http://www.smh.com.au/national/healers-and-wheelerdealers-20110408-1d7g0.html Page 1 of 3 ''Thisphones combination and high-speed of events internet. was unlikely to come about again.'' he says. It was also obvious that the next person wanting to investigate the remedy might not ask first. ! Now they had a chance to see whether their traditional knowledge could help millions of other people, he said. ''So who were we to withhold our Thistechnology had happened from the whenrest of a theUS worldcompany if it could was granted be of use?'' a patent on a new variety of basmati rice in the late 1990s, a dispute that led to protests by Asian farmers and challenges to the patent. To clinch the deal, there were his unique academic credentials, his plan to carry out his research at the University of NSW in collaboration with Also,Professor University Bill Walsh of Hawaii and to researchers pay for it by who working obtained in a patentshospital. for new varieties of taro found themselves under pressure to revoke the patents on the basis that taro is sacred to indigenous Hawaiians. The researchers finally abandoned them in 2006. ''This combination of events was unlikely to come about again.'' he says. It was also obvious that the next person wanting to investigate the Forremedy more might than nota decade ask first. there have been tensions between developing countries that are rich in biodiversity and developed countries with pharmaceutical industries. These have stymied United Nations negotiations on how best to use the intellectual property system to protect genetic This had happened when a US company was granted a patent on a new variety of basmati rice in the late 1990s, a dispute that led to protests by resources, traditional knowledge and traditional cultural expressions. Asian farmers and challenges to the patent. Discussions came ''perilously close to collapse'' in 2009, the Innovation Minister, Senator Kim Carr, says. But Australia played a ''significant role'' Also, University of Hawaii researchers who obtained patents for new varieties of taro found themselves under pressure to revoke the patents on in re-establishing the process and an intergovernmental committee of the World Intellectual Property Organisation is working on an international the basis that taro is sacred to indigenous Hawaiians. The researchers finally abandoned them in 2006. legal instrument for this protection, with recommendations to be presented at a critical assembly of the organisation in Geneva in September. For more than a decade there have been tensions between developing countries that are rich in biodiversity and developed countries with In another recent positive development, a UN summit on biodiversity in Japan late last year resulted in the first internationally binding agreement to pharmaceutical industries. These have stymied United Nations negotiations on how best to use the intellectual property system to protect genetic prevent biopiracy. The new protocol requires informed consent for researchers getting access to genetic resources and agreement on ''fair and resources, traditional knowledge and traditional cultural expressions. equitable'' sharing of any resulting benefits with the party providing the resources. Discussions came ''perilously close to collapse'' in 2009, the Innovation Minister, Senator Kim Carr, says. But Australia played a ''significant role'' Dr Daniel Robinson, an expert on indigenous intellectual property at the University of NSW, says one problem is that the US has not adopted the in re-establishing the process and an intergovernmental committee of the World Intellectual Property Organisation is working on an international agreement and it could take years for the other 190 or more countries to implement it. ''But it should limit the opportunities for biopiracy to occur,'' legal instrument for this protection, with recommendations to be presented at a critical assembly of the organisation in Geneva in September. he says. In another recent positive development, a UN summit on biodiversity in Japan late last year resulted in the first internationally binding agreement to By 2003 Matheson had unanimous approval from the Koutu Nui to carry out his research. He compared different formulations of the traditional prevent biopiracy. The new protocol requires informed consent for researchers getting access to genetic resources and agreement on ''fair and treatment and used ''educated guesses'' to whittle down a dozen or more plants to four, ruling out unimportant additives, such as flowers used for equitable'' sharing of any resulting benefits with the party providing the resources. fragrance. Dr Daniel Robinson, an expert on indigenous intellectual property at the University of NSW, says one problem is that the US has not adopted the The fact it worked via the skin helped him narrow down the possible active ingredients in the plants and he began to test his extracts on animals. agreement and it could take years for the other 190 or more countries to implement it. ''But it should limit the opportunities for biopiracy to occur,'' Whenhe says. early results showed promising effects in thickening the skin, he rushed back to the Cook Islands to establish a company with the Koutu Nui. MoreBy 2003 recently, Matheson when had ''extremely unanimous dramatic approval results'' from showedthe Koutu an Nui extract to carry of one out plant his research. can promote He compared large amounts different of bone formulations formation, of athe new traditional strategy wastreatment needed. and A used private ''educated Australian guesses'' company, to whittle Cimtech, down which a dozen has attracted or more plantsfederal to government four, ruling grants,out unimportant was set up. additives, Matheson, such the as Koutu flowers Nui used and for thefragrance. university's commercial arm, NewSouth Innovations, are shareholders. ! The companyfact it worked has notvia thepublished skin helped its scientific him narrow results down and the does possible not name active the ingredientsplants but has in the applied plants for and four he patents. began to Matheson test his extractssays when on animals.he ! started he didn't realise how important it was to protect scientific knowledge for it to be commercialised. When early results showed promising effects in thickening the skin, he rushed back to the Cook Islands to establish a company with the Koutu Nui. This is the message of a new program, Dream Shield, launched last year by Senator Carr, to help Aborigines turn their indigenous knowledge into More recently, when ''extremely dramatic results'' showed an extract of one plant can promote large amounts of bone formation, a new strategy commercial products. ''Shhhh. Keep quite about your new invention or design until you've got IP protection,'' it advises. was needed. A private Australian company, Cimtech, which has attracted federal government grants, was set up. Matheson, the Koutu Nui and Carrthe university's said it was commercial troubling that arm, so NewSouthfew indigenous Innovations, businesses are shareholders.safeguarded their intellectual property. Only four of 9000 callers to IP Australia in a survey last year identified themselves as indigenous. The company has not published its scientific results and does not name the plants but has applied for four patents. Matheson says when he Dreamstarted Shieldhe didn't highlights realise howanother important success it was story: to thatprotect of thescientific Jarlmadangah knowledge Burru for itAboriginal to be commercialised. Community in the Kimberley, which has patented compounds from a traditional bark remedy for skin conditions. This is the message of a new program, Dream Shield, launched last year by Senator Carr, to help Aborigines turn their indigenous knowledge into Thecommercial community products. became ''Shhhh. interested Keep in quite its commercial about your potential new invention after one or designof the elders, until you've John gotWatson, IP protection,'' lost a finger it advises. while hunting crocodiles and used a wad of chewed bark from the marjala plant to dull the pain. Carr said it was troubling that so few indigenous businesses safeguarded their intellectual property. Only four of 9000 callers to IP Australia in a Thesurvey community last year approached identified themselves researchers as atindigenous. Griffith University, who extracted two painkillers from the bark. A company has been set up and discussions are under way on whether the plant will be cultivated or the bark harvested from the wild, with the first product most likely to be an Dream Shield highlights another success story: that of the Jarlmadangah Burru Aboriginal Community in the Kimberley, which has patented over-the-counter skin cream. compounds from a traditional bark remedy for skin conditions. ''This medicine has been used by our people for many generations and the thought that it could soon be improving the lives of millions of people The community became interested in its commercial potential after one of the elders, John Watson, lost a finger while hunting crocodiles and used around the world fills us with pride,'' the community chairman, William Watson, says. a wad of chewed bark from the marjala plant to dull the pain. On the other hand, the Mirarr people are among Aboriginal groups who objected last year to a patent application by Mary Kay to extract The community approached researchers at Griffith University, who extracted two painkillers from the bark. A company has been set up and ingredients from the Kakadu plum for a cosmetic product. discussions are under way on whether the plant will be cultivated or the bark harvested from the wild, with the first product most likely to be an Robinsonover-the-counter challenged skin thecream. patent application on the grounds of lack of novelty and inventiveness, because he was concerned Aboriginal people had ''This medicine has been used by our people for many generations and the thought that it could soon be improving the lives of millions of people around the world fills us with pride,'' the community chairman, William Watson, says. http://www.smh.com.au/national/healers-and-wheelerdealers-20110408-1d7g0.html Page 2 of 3 On the other hand, the Mirarr people are among Aboriginal groups who objected last year to a patent application by Mary Kay to extract ingredients from the Kakadu plum for a cosmetic product.

Robinson challenged the patent application on the grounds of lack of novelty and inventiveness, because he was concerned Aboriginal people had

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The ability to navigate the vast oceans, the ability to recover from injury, and the need to live sustainably on our small island homes was fundamental to the survival and success of our people.

Cook Islands Medical Research CIMRAD And Development Group

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Having grown up in the Cook Islands and aware of the Maori Medicines, I had completed medical training at University of New South Wales in Sydney and done additional research into bone healing, and Masters of Biomedical Engineering by research, the prospect of investigating our traditional medicines in a scientific format was intriguing. I had recently fractured my own leg playing rugby, and a Cook Islands National Rugby Teammate who had a devastating bone injury a few years earlier had recovered remarkably using te vairakau ati.

The Koutu Nui and I discussed in detail the research and development of Te Vairakau Ati, and agreed on how to share ownership and benefits, with proposals for the protection and utilization of traditional knowledge, and detailed pilot studies provided for prior informed consent. This resulted in the Koutu Nui becoming beneficiaries at all levels of the project.

The Koutu Nui sought legal advice confirming their right to participate, and the Koutu Nui and I received vocal support from the Cook Island government to pursue the project.

The Koutu Nui executive presented the proposal to the general assembly and received unanimous support from the Aronga Mana.

The Taunga Vairakau gathered the healing plants, for provision to the Koutu Nui

Cook Islands Medical Research CIMRAD And Development Group

! In the years since, Dr Matheson has studied various extracts of Cook Island plants in collaboration with Professor Bill Walsh, of the orthopaedic research laboratories at Prince of Wales Hospital.

His research in animals has shown that an extract of three plants applied to the skin can improve wound healing and repair ageing skin.

An extract from a fourth plant was found to have ''dramatic'' results, promoting large amounts of new bone formation within a week, he said.

The Cook Island chiefs have always been closely involved in the project and are shareholders in an Australian company, Cimtech, that was set up to commercialise the findings. Dr Matheson and UNSW's technology transfer office, NewSouth Innovations, are the other two shareholders.

The project is about to move to a new phase, with cultivation and refinement of the four plants to start in the Cook Islands, providing new jobs for the popular tourist destination.

Dr Matheson said he hopes a cosmetic skincare product, based on the plant extracts, will be marketed within two years.

This will fund further research on the bone growth product, which could have applications in treating fractures, osteoporosis, and other conditions including spinal fusion for back pain. The Koutu Nui president, Te Tika Mataiapo, Dorice Reid, said the research was a first for the Cook Islands and would provide a new industry.

''It is such an important venture for us. We are really proud and excited that this traditional medicine can help people throughout the world. And the people of the Cook Islands will also receive a great deal of benefit from it,'' she said.

It comes at a critical time in international diplomacy to try to prevent biopiracy, or the misappropriation of genetic resources and indigenous knowledge.

http://www.smh.com.au/national/medicine-man-makes-no-bones-about-paying-dues-20110408-1d7o2.html Page 1 of 2

The Koutu Nui symbolically handed over Te Vairakau Ati.

Q&)&"%?H'"/*'Q&)$-#)' TheHealers research and wheeler-dealers was undertaken with Professor W R Walsh from UNSW in the world leading Deborah Smith SurgicaApril 9, 2011l and Orthopaedic Research Laboratories.

Plant cures ... Bill Walsh and Graham Matheson monitor bone regeneration. Photo: Dallas Kilponen

Cook Islands Medical Research CIMRAD And Development Group

! Cook Islands Medical Research CIMRAD And Development Group ! ! Subsequent to this finding the slides were stained with SAF-O stain for cartilage group. The treated sham group also appeared to have an increase in cell populations of cartilage and woven bone. identification. The proteoglycans in cartilage stain a deep purple with this technique. Saf-o stain TheSubsequent research to this discovered finding the slides that were the stained traditional with SAF practices-O stain for cartilagecontained identification. extracts The that proteoglycans absorb inthrough cartilage !"!#$%&stain a deep' &(#)%*+#,"&-))$&./0%12/&3#0/)56%+#)1&4)5&purple with this technique. 7$#1&8"%0+9&:5)4"//#)1%0/& the skin to influence the healing of bone, with more new bone and cartilage at fracture sites. !

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Sham control 3.25 0.5 Ovx Control 2.4 0.894427 Note the large amount of Saf-O proteoglycan stain found at the fracture site in the sham Sham rx 3.8 0.83666

andOvx in rx particular the OVX treated4.272727 animals. This correlates1.00905 well with the cartilage found

Table 4: Histological Score for OVX and Sham Treated and Control groups in the fracture sites.

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Cook Islands Medical Research !!Investigation of a novel topical agent: the influence of the in-vivo biology of skin….Matheson, GrahamCIMRAD Hugh, Clinical And Development Group School - Prince of Wales Hospital, Faculty of Medicine, UNSW Thesis (Ph.D) - University of New South Wales, 2010(L711(=#O'(,;,*1,.1#(%+1*+#( Figure! 6-6: Graph of the histological score comparing the Sham and OVX treated and ! control groups after 3 weeks of fracture healing

180 6.4.4.3 eA in coconut oil

Plant A was extracted with ethanol, and then into coconut oil for assessment.

(a)

(b) shaved of fur. The muscles were separated without division and the ulna identified and separated from Figurethe attached 6-12: Test eA in coconut oil X-ray (a) and CT (b) showing the empty critical muscles,shaved of which fur. The were muscles retracted. were Theseparated ulna was without divided division by oscillation and the ulnasaw identifiedapproximately and separated 20mm distal from todefect thethe attachedhumero of 20mm- ulna (black arrows) in the ulna after one week and new bone (blue arrows) jointmuscles, and a which second were incision retracted. 20mm Thedistal ul againna was to divided the first. by The oscillation 20mm segmentsaw approximately of ulna is then 20mm removed distal to from the thehumero forearm-ulna dividingjoint and the a second membrane incision between 20mm the distal ulna again and the to theradius. first. All The care 20mm was segment taken to ofavoid ulna damaging is then removed the radiusThe from plainand the to filmforearm avoid radiology shows some opacity in the defect but this is appreciated much leavingdividing bone the membrane fragments betweenor periosteum the ulna behind. and theThe radius. muscles All werecare wasreleased taken from to avoid traction damaging and the the skin radius closed. and Intra to avoid- operativeleaving bone temgesic fragments and cephazolinor periosteum were behind. administered. The muscles A patch were of releasedfur was 7cm from by traction 7cm was and shaved the skin onbetter closed. the backon Intra the of -CTthe image showing opacities throughout the defect. The bone threshold set animaloperative and temgesic the oil remedy and cephazolin applied following were administered. surgery. The A animalspatch of recovered fur was 7cm fully by and 7cm were was ambulant shaved on on the the back operated of the limb. 6.4.4.3 eA in coconut oil Observationsanimal and the were oil remedy carried appliedout daily following for a week surgery. with no The complications animals recovered and daily fully oil andapplication were ambulant continuedfor on forthe one defectoperated week. in the limb. CT is for spongy bone 168 Hounsfield units.

TheObservations animals were were sacrificed carried out by dailyintra -forcardiac a week barbituate with no complicationsinjection and the and limbs daily harvested, oil application x-rayed, continued CT performed for one week. and the Plant A was extracted with ethanol, and then into coconut oil for assessment. boneThe animals prepared were for histologicalsacrificed by analysis. intra-cardiac The limbs barbituate were injectionplaced into and 10% the formiclimbs harvested,acid for 2 weeks x-rayed, to CTremove performed calcified and the componentbone prepareds of bone,for histological and then analysis.embedded The into limbs paraffin were and placed slides into constructed 10% formic using acid standardfor 2 weeks techniques. to remove The calcified slides were stainedcomponent withs Haematoxylin of bone, and thenand Eosin,embedded Tetrachrome into paraffin or Pentachrome and slides constructed at 1.25 objective using standard magnifications techniques. and a The review slides of thewere histologystained with followed. Haematoxylin and Eosin, Tetrachrome or Pentachrome at 1.25 objective magnifications and a review of the histology followed. Critical Defect - Results AllCritical animals Defect tolerated - Results the surgery and the treatment well, apart from two intra-operative complications (radius damaged by (a) theAll animalssaw), resulting tolerated in theeuthanasia surgery ofand control the treatment animals. well,There apart wasFurther from no observable two rintraesearch-operative effect determinedin thecomplications post surgical which (radius progress plantdamaged of note.extracts by were responsible for the skin regeneration, Thethe saw),fractures resulting were inanalysed euthanasia under of Xcontrol-ray and animals. CT for Therethe degree wasand no of observableoptimizedfracture healing, effect the and in extraction the microscopy post surgical processes.for histologicalprogress of note.These plants have been cultivated from seedlings, analysis. defect and some fragments of bone are found in the defect; these are distinct from new The fractures were analysed under X-ray and CT for the degreeand of arefracture grown healing, extracted and microscopy refined for histological 6.4.4.3 and standardized eA in coconut oil in the Cook Islands and used to make analysis. bone by the stainingTeTika orange Skincare like cortical products. bone rather than red like new bone. Control Plant A was extracted with ethanol, and then into coconut oil for assessment. The control group received coconut oil alone, to ensure that they received the same care and attention as the treat ed Control groups, and to investigate whether coconut oil itself is responsible for any biological activity.(c) (a) The control group received coconut oil alone, to ensure thateAA theyplantin coconut received that oil wasthe (left), same rejected and care extract and from ANPKattention th combinede skinas the project treat in coconuted was (right) found to be the essential component for groups, and to investigate whether coconut oil itself is responsibleThebone histology for regenerati any biological showson, thatactivity. butthe regions also hasaround a the synergistic bone defect dual and the co periosteummponent near required the injury for are efficacy, surrounded and The control samples show minimal new bone growth6.4.4.2 afterANPK one week.in Coconut There Oilis a small amount of new bone arising from theThe periosteum control samples of the showadjacent minimal radius. new Th boneere is growth a new afterwoven oneby demonstratedbone week. large arising Thereamount from is a ofthe ansmall cartilage periosteum influence amount (blue) ofand new onendosteumand bone healingnew arising woven near bonefrom the bone in(red) biologically surrounding challenging the damaged corticalscenarios bone including (orange). There is some fibrous tissue and inflammatory material in the defect near the bone ends.. Plant A was defectthe periosteum margin. Within of the theadjacent defect radius. there isTh noere new isThe a bone new original growth.woven combination bone Inflammatory arising from of material all the four periosteum fills plants the majority extractedand endosteum of the into defect coconut near and the oil is assessed extractedcritical wi defectsth ethanol, and and bonethen into grafting coconut .oil for Thi assessments plant is. The wild histology harvested of the extracted plant A extracts concentrated is the same andas (b) somedefect fragments margin. Within of bone the are defect found there in the is nodefect; new bonethese growth.are distinct Inflammatory from new materialbone by fillsthe thestaining majority orange of the like defect cortical and bone (a) thestandardized histology following in the Cookthe application Islands offor the the combined production extracts. of TVATI. 194 rathersome fragmentsthan red like of newbone bone. are found in the defect;radiologically these are di andstinct histologically. from new bone by the staining orange like cortical bone Figure 6-12: Test eA in coconut oil X-ray (a) and CT (b) showing the empty critical rather than red like new bone. defect of 20mm (black arrows) in the ulna after one week and new bone (blue arrows)

The plain film radiology shows some opacity in the defect but this is appreciated much semi quantitative measure of bone growth in the defect was undertaken by assessing the better on the CT image showing opacities throughout the defect. The bone threshold set pre sence of cartilage or bone in the defect for each of the samples in the groups of plant for the defect in the CT is for spongy bone 168 Hounsfield units. (a) (a) (d) (b) (a) A extractionsThe plain film and radiology the remaining shows some plants opacity NPK. in the defect but this is appreciated much better on the CT image showing Figure 6-11: Representative histology of 1 week treated ANPK in coconut oil critical opacities throughout the defect. The bone thresholdFigure set 6for-12 the: Test defect eA in thecoconut CT is oil for X spongy-ray (a) bone and CT168 (b) Hounsfield showing units. the empty critical defect tetrachrome (a) and (b) showing the margin of the defect (black arrow) and new defect of 20mm (black arrows) in the ulna after one week and new bone (blue arrows) bone in red, and new cartilage in blue. The plain film radiology shows some opacity in the defect but this is appreciated much The histology shows that the regions around the bone defect and the periosteum near the better on the CT image showing opacities throughout the defect. The bone threshold set injury are surrounded by large amount of cartilage (blue) and new woven bone (red) for the defect in the CT is for spongy bone 168 Hounsfield units. surrounding the damaged cortical bone (orange). There is some fibrous tissue and (b) inflammatory material in the defect near the bone ends. Figure 6-10: Test ANPK coconut oil X-ray (a) and CTdefect (b) showing and some the empty fragments critical of bone are found in the defect; these are distinct from new 6.4.4.3 eA in coconut oil defect of 20mm (black arrows) in the ulna after one week and new bone (blue arrows)

bone by the staining orange like cortical bone rather than red like new bone. Plant A was extracted with ethanol, and then into coconut oil for assessment.

(c) (a) On the x-ray and CT there is a Bonesmall amount regeneration of opacity withinafter theone defect, eAweek in however coconut - control193 it is oil (left),(left) andvs extractTVAT I ANPK(right) combined in coconut (right) FigureThe fraction6-22: Graph of Plant displaying A from ethanol the histological into coconut score oil generated ofThe the histologydifferent more new fra shows ctionsbone andthat of plantca thertilage regionsA growth around in the defect the bone than defect and the periosteum near the injury are surrounded not clear if this is new bone, or fragments. The CT6.4.4.2 does show ANPK new densitiesin Coconut in the Oil extracts that do not contain plant A, or ethanol extracts ofby plant large A that amount did not ofuse cartilage coconut oil. (blue) The Intermediate and new woven fraction boneof (red) surrounding the damaged cortical bone extracts, showing the eAo group with significantly more bone and cartilage in the defect plantFrom A inthe coconut initial did pilot not have study a significant this project amount expandedof new(orange). bone orto cartilage Theremany isgrowthpre some-clinical in fibrousthe de studies,fect. tissue andpublication inflammatory of a material in the defect near the bone ends.. Plant A was defect arising from both ends of the defect and the middle of theCook Islands Medica defect.l Research The bone TheCIMRAD original And Development Group combination of all four plants extracted into coconut oil is assessed PhD and has been granted patents! region. in majorextracted jurisdictions! with ethanol, around and the then world into coconut recognizing oil for assessmentthat we . The histology of the plant A extracts is the same as Cook Islands Medical Research Critical Defect - Discussion CIMRAD And Development Group (a) 194 threshold set forhad the developeddefect in the CT and is for improved 250 Hounsfield !upon units. our traditionalthe !histology knowledge following, and the recognized application the of themet combinedhods did extracts. The aim of this study was to identify whetherradiologically or not the topical and histologically.treatment influenced bone healing. The short time frame indeed influenced the biology in an novel and inventive manner. limits the extrapolation of the data for use as clinically relevant however the intention was (a)not to prove efficacy, but to provide a means of identifying active fractions of the plant extracts. The fraction of Plant A from ethanol into coconut oil generated more new bone and TheImporta criticalntly defect we in the also ulna overcame was chosen for objections this study as from it has been both validated China by and numerous India studiespatent as a examiners non-healing with cartilagerespect growth to the in the patenting defect than of plants extracts used that do in not traditional contain plantmedicines A, or ethanol who recognized the unique! ! semi quantitative measure of bone growth in the defect was undertaken by assessing the nature of our methods and uses. 192 extracts of plant A that did not use coconut oil. The Intermediate fraction of plant A in 194 presence of cartilage or bone in the defect for each of the samples in the groups of plant

coconut did not have a significant amount of new bone or cartilage growth in the defect.(a) (d) (b) A extractionsThe plain film and radiology the remaining shows some plants opacity NPK. in the defect but this is appreciated much better on the CT image showing Figure 6-11: Representative histology of 1 week treated ANPK in coconut oil critical opacities throughout the defect. The bone thresholdFigure set 6for-12 the: Test defect eA in thecoconut CT is oil for X spongy-ray (a) bone and CT168 (b) Hounsfield showing units. the empty critical defect tetrachrome (a) and (b) showing the margin of the defect (black arrow) and new defect of 20mm (black arrows) in the ulna after one week and new bone (blue arrows) bone in red, and new cartilage in blue. The plain film radiology shows some opacity in the defect but this is appreciated much The histology shows that the regions around the bone defect and the periosteum near the better on the CT image showing opacities throughout the defect. The bone threshold set injury are surrounded by large amount of cartilage (blue) and new woven bone (red) for the defect in the CT is for spongy bone 168 Hounsfield units. surrounding the damaged cortical bone (orange). There is some fibrous tissue and (b) Figureinflammatory 6-10: Test material ANPK in thecoconut defect oil near X -theray bone (a) and ends. CT (b) showing the empty critical

Cook Islands Medical Research CIMRAD And Development Group defect of 20mm (black arrows) in the ulna after one week and new bone (blue arrows) ! 203 On the x-ray and CT there is a small amount of opacity within the defect, however193 it is

not clear ifFigure thisThe is fraction6 new-22 : bone,Graph of Plant or displaying fragments. A from ethanol the The histological CTinto doescoconut show score oil newgenerated of the densities different more in new the fra ctionsbone and of plantcartilage A growth in the defect than extracts that do not contain plant A, or ethanol extracts of plant A that did not use coconut oil. The Intermediate fraction of extracts, showing the eAo group with significantly more bone and cartilage in the defect defect arising plant from A both in coconut ends ofdid the not defect have a and significant the middle amount of theof new defect. bone Theor cartilage bone growth in the defect. region. threshold set forCritical the defect Defect in the- Discussion CT is for 250 Hounsfield units. The aim of this study was to identify whether or not the topical treatment influenced bone healing. The short time frame

limits the extrapolation of the data for use as clinically relevant however the intention was (a)not to prove efficacy, but to provide a means of identifying active fractions of the plant extracts. The fraction of Plant A from ethanol into coconut oil generated more new bone and The critical defect in the ulna was chosen for this study as it has been validated by numerous studies as a non-healing cartilage growth in the defect than extracts that do not contain plant A, or ethanol ! ! 192 extracts of plant A that did not use coconut oil. The Intermediate fraction of plant A in 194

coconut did not have a significant amount of new bone or cartilage growth in the defect.

203 1"#&/#)' Methods and compositions for bone One or more of Vigna marina, Cocos and cartilage repair nucifera L. or Terminalia catappa L. ! Australia 2010330704 extracts for treating wounds, skin ! Brazil BR112012013968 disorders and hair loss ! China 201080063286.8 ! Australia 2010244969 ! Europe 10835314.5 ! Brazil PI1007711.1 ! Singapore 201204204-0 ! Canada 2760812 ! India 6044/DELNP/2012 ! China 201080027510.8 ! United States13/514,249; ! China 201410275983.X 15/670,562 ! Europe 10771898.3 ! Japan 2012-508854 ! Japan 2015-126421 ! Korea 10-2011-7028528 Methods and compositions for ! Singapore 201108056-1 maintaining and improving the health of ! United States 13/318,596 skin ! India 9489/DELNP/2011 ! Australia 2011325867 ! Singapore 201303416-0

We discovered that our traditional treatment for bone and soft tissue healing had ingredients that repaired bone – used in TVATI, and also ingredients that regenerated soft tissue – used in TeTika.

Cook Islands Medical Research CIMRAD And Development Group

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Global BiodiversityGlobal Outlook Global Biodiversity Outlook  A mid-term assessment of progress towards the implementation of the Strategic Plan for Biodiversity 2011-2020  Box 16.1. Access and benefit sharing in action—Researching traditional bone-healing techniques in the Cook Islands

Dr Graham Matheson, a medical researcher from the Cook Islands, observed the traditional application of plant-based extracts for treatment of bone fractures and other medical and therapeutic applications, by members of his community, friends and family. In 2003 he developed a proposal for the investigation and potential commercialization of medical and therapeutic remedies and cosmetic applications based on those plant extracts and reached a benefit-sharing agreement with the recognized indigenous representative body—the Koutu Nui. This led to the establishment of the company ‘CIMTECH’ which incorporates the Koutu Nui as a shareholder.213

The Koutu Nui shareholding value is estimated to be at least $150,000. The research income to CIMTECH includes: $264,000 in grants received from the Australian Government, and $74,000 from University 4 of New South Wales. It also includes employment of 12 people on a part time basis in the Cook Islands, $560,000 in pre-seed investment in 2010 and a further $800,000 in 2011 for research and development. The project is expected to contribute to the local economy through the laboratory and processing facility in Raratonga, as well as through sales, marketing and tourism, including use of products in spas and hotels.

Matheson and CIMTECH have filed for a number of patents covering three distinct areas: bone and cartilage treatment, wound healing, and skin care treatments. Preliminary production and processing2 of essential oil solutions has begun and a skincare line called “Te Tika” has been launched.214

The Cook Islands Access and Benefit Sharing agreement was assessed independently by Dr Actions to Enhance Progress Towards the Target Daniel Robinson and found to be towards world’s best practice for the Nagoya Protocol. Our achievements!e following actions were would recognized support theduring full the mid term• Making assessment national ofinformation the 2020 available Biodiversity through goals. achievement of Target 16 the ABS Clearing House (see Box 16.2) The Cook Islands was awarded a Nagoya Protocol Implementation Fund Grant in excess of $1 million• For countries to facilitate that have the not nationalyet done so, framework to and• Undertaking support theawareness Cook raising Islands and capacity to participate deposit their instrument of ratification, acceptance, building activities, including by engaging with indig- maximallyapproval or accession in the to project. the Nagoya Technology Protocol as soon transfers enous haveand local resulted communities in extraction and the private refining sector and 3 analyticalas possible to ensure equipment full participation including in the laboratories,Protocol negative pressure extraction system, spectrophotometry and Gas Chromatography Mass Spectrometry within the Cook Islands, and all• Puttingproduction in place, refining by 2015, and legislative, analysis administra is performed- within the Cook Islands, and the corporate Secretariat of the Convention on Biological Diversity structurestive or policy are measures now entirely and institutional controlled structures and owned by Cook Islanders. World Trade Centre for implementing the Nagoya Protocol 413 St. Jacques Street, Suite 800 The Koutu Nui are partners at all levels of benefit sharing, from provision of active plant Montreal, Quebec, Canada H2Y 1N9 materialBox 16.2. in a T sustainablehe Access and manner, Benefit-sharing to being shareholders Clearing-house in the IP company, to beneficiaries of a Phone: +1 514 288 2220 royalty on profits, they benefit from supply, capital growth and net profits related to the project. Article 14 of the Nagoya Protocol establishes an ABS Clearing-House as part of the clearing-house Fax: +1 514 288 6588 E-mail: [email protected] mechanism of the Convention. The Secretariat of the CBD is currently implementing the pilot phase of Website: www.cbd.int the ABS Clearing-House. Once fully operational, the ABS Clearing-House will serve as a means for Parties to share information related to access and benefit-sharing, including relevant legislative, administrative and policy measures, national focal points and competent national authorities, and permits or their equivalents, among other things. The ABS Clearing-House will play a key role in enhancing legal certainty and transparency and in promoting compliance. Having a fully functional ABS Clearing-House by the time Cook Islands Medical Research of entry into force is essential for making the Protocol operational, and willCIMRAD significantly And Development Group contribute towards achieving Aichi Target 16.215 !

106 Strategic Goal D

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Cook Islands Medical Research CIMRAD And Development Group ! ! ! ! (ACN 127 621 345) BOARD MEETING

Wednesday 24 July 2013 from 11.30am to 1.30pm To be held at the Sydney offices of Lawler Partners, 1 O'Connell St Sydney NSW 2000

AGENDA

1. Welcome and attendance 2. Minutes from previous meeting SR 3. Finances a. Draft June accounts SR/MH b. Yearend process MH c. Audit MH d. R&D claim MH e. Budget & cash flow MH f. Bookkeeping 4. Strategy a. Matheson Health report GM 5. Related party agreements a. Matheson Health b. Skincare Ventures 6. Other business a. OH&S

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!#.),-.%,8-*0"5-2),9)2).)*-0"#.:,,;<<5"'-0"#.,#/,"=<*#()%,)>0*-'0"#., Q!R)CP)IJB)KN80)'1."?@)&,0#,A;@B,C) !"#"$%&$'(")"*%+&$D,0#,=))0,".0)*.-0"#.-5,&0-.%-*%&:,()*%+$',%% -./01234% % 8#=<#.).0,EF,G3H)'0"(),I' G":$,%% H%I&J$KL$*%M2/1% 5$667%8$6*7% 9":;$<&6%=6:$*>*?<$< % @*&"A%+"*&:&6#"% CIMTECH has procured technical advisory services and assistance to improve the extraction protocol for natural biologically B&&C%D>&*:)6?:7%:&%O)&:$%'&*%"%&E$%PB9-%"6F%E?O)?FQ;$"F<>"R$%<"K>E?6#%<7<:$K% '&*%7&)*%O)?:$%J"*?&)<%">>E?R":?&6*?R$F%?6%"%!$"C%-R?$6:?'?R%8M%#$6$*":&*S%W$% 6&:$%:;":%87F*&#$6%?<%"%>*"R:?R"E%R"**?$*%#"<%R;&?R$%'&*%:;$%B&&C%D*&'?E$%"6F%<>;$*$%&'%"R:?J?:7%?6%:;$%!"R?'?R%D*?J":$%?6<:?:):?&6$R?"E?<:<%"*$%?6%:;$%:$**?:&*7%<$J$*"E%:?K$<%>$*%7$"*S%%D6%"FF?:?&6%V$%;"J$%"% Matheson Enterprises produced several bench sized extraction variations for analysis and efficacy testing by CIMTECH partners, ">>E?R":?&6Q:*"?6?6#%E"L%'"R?E?:7%?6%&)*%-7F6$7%K"?6%&''?R$%V;$*$%<)L<$O)$6:%:*"?6?6#%$J$6:<%R"6%:"C$%>E"R$%?'%F$"R$%<"K>E$*S MS and spectrophotometry to develop fingerprint patterns for% reference and % standardization of extraction techniques. !"#$%&'()Q:S!TU5IBIB)!"#$%&'()*+,)-.%&)S%00)!V+*-1?$+-+1) %

) Gas-Chromatography)-Mass- ) The GC-MS was configured and testingSpectromete was establishedr and Spectrophotometry with the) ability to characterize and identify the components of coconut) 5%1-)E?) W+0*1#V-#?,) U-6 ) oil, using standard analytical techniques and accessing mass fragment librariesRecirculation to identify the solvent constituents. extraction This with same technique ) allows for the identification of any variations to the coconut oil that are introducedchilled by condensors the extract ion and integration of the plant extract into the coconut oil. !"#$%&'()Q:S!)RUHBPB) PB9-U.!M2M2%X=DY% Q:S!TU5IBIB)2X/4)Q%0):"1?$%-?Y1%V"TS%00)!V+*-1?$+-+1)) /% % x P"<%B;*&K":&#*">;%9"<<%->$R:*&K$:$*A%R&K>*?;%V?:;%@):&K":?R%4E&V%B&6:*&E ON BOTH VACUUM PUMP %AND COOLER x %-!ZUM2/2%->E?:Q<>E?:E$<<%?6[$R:&*% x %B">?EE"*7%B&E)K6%G?*$R:%D6:$*'"R$A%R&K>":?LE$%V?:;%)>%:&%2SH0KK%DG%K$#"L&*$% R">?EE"*7%R&E)K6% x %G$?F%&J$6%;$":?6#%*":$% q /02 BQK?6A%8?#;%>*$<<)*$Q'E&V%>6$)K":?R"R?:7%Rotary Film Evaporation F)"E%?6E$:%F?''$*$6:?"E%N)*L&K&E$R)E"*%!)K>%XN9!Y%J"R))K%<7<:$K%F$E?J$*<%;?#;$<:% <$6

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Negative Pressure extraction glassware Hydraulic press extraction 8. COOLANT FLOWING THRU CONDENSER FROM THE BOTTOM TO TOP

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Cook Islands Medical Research CIMRAD And Development Group

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Stage Two – Extraction using scaled up materials Over 50kg utilized in test batches 5kg test batch 10kg test batch 20kg test batch 20 kg test batch

Solvent acquisition. Batch size standardized for 20kg.

Cook Islands Medical Research CIMRAD And Development Group ! ! ! ! (ACN 127 621 345) BOARD MEETING

Wednesday 24 July 2013 from 11.30am to 1.30pm To be held at the Sydney offices of Lawler Partners, 1 O'Connell St Sydney NSW 2000

AGENDA

1. Welcome and attendance 2. Minutes from previous meeting SR 3. Finances a. Draft June accounts SR/MH b. Yearend process MH c. Audit MH d. R&D claim MH e. Budget & cash flow MH f. Bookkeeping 4. Strategy a. Matheson Health report GM 5. Related party agreements a. Matheson Health b. Skincare Ventures 6. Other business a. OH&S

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TeTika Skincare - utilizing the skin regenerating plant extracts was launched in 2012 and 90% of the profits have been retained in the Cook Islands.

TeTika Skincare was presented as a gift to the Queen from the Cook Islands for her diamond Jubilee. The Koutu Nui and I present the gift to the Cook Islands Prime Minister the Hon Henry Puna.

Cook Islands Medical Research CIMRAD And Development Group

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The Cook Islands has benefited greatly from the technological developments of other cultures. We have electricity, cars, telecommunications, and medicines that greatly improve the health and wellbeing of our people. A major consideration at the outset of this project was that if our culture held a secret that could improve the health and wellbeing of people of this world, we felt an obligation to pursue it.

Prior to embarking upon this process, the Cook Islands did not officially recognize the value of its traditional maori medicines, there was no framework to develop nor to protect the utilization or acquisition of the knowledge, and no conceptual framework that it could be developed from within the culture itself.

As a result of the project, and with the support of the UN and affiliated bodies, we embarked upon engagement with the community within the Cook Islands, elevated the esteem of the traditional heritage and with it the esteem of the people including Polynesians more broadly, we have a framework in place to manage and facilitate future development, with the technology to support potential new projects.

Following this engagement and regulatory reform, the Cook Islands took to heart the UN statement on the rights of the indigenous persons, and at their national health conference officially requested the re-introduction of our traditional medicines, specifically the researched and refined TVATI into our healthcare system Te Marae Ora, and is now about to become available more generally within and from the Cook Islands. To date the feedback from these applications matches the preclinical data demonstrating influence on bone biology with similar results in humans and veterinary applications at individual levels.

Whilst non Cook Islanders may purchase TVATI for use, it is in accordance with our traditions that TVATI to be provided free to Cook Islanders within the Cook Islands, in association with Te Marae Ora, as we are only custodians on behalf of the people, and not owners as separate from the people.

Cook Islands Medical Research CIMRAD And Development Group

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TVATI™.COM

Cook Islands Medical Research CIMRAD And Development Group

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