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LISA-MARIE CRICHTON & ASSOCIATES
MARINE BIOTECHNOLOGY MANAGEMENT CONSULTING FOR COMMERCIAL COLLABORATIONS WITH SIGNIFICANT
PARTNERS IN THE SOUTH PACIFIC REGION
MANAGEMENT & CONSULTING IN PRIVATE SECTOR COMMERCIAL COLLABORATIONS IN MARINE
BIOTECHNOLOGY NEW PRODUCT DEVELOPMENTWITH SIGNIFICANT PARTNERS IN THE SOUTH PACIFIC
REGION
A Private Sector Marine Biotechnology Management Consulting business, working in collaboration with Significant
Partners from the South Pacific Region and leading local and International Experienced World-Class Experts & Associates.
We collaborate in innovative, commercially viable, sectors of the Marine Biotechnology industry in marine biotechnology
product scientific research, bioprospecting towards the discovery of “new-to-science” products for development and
commercialisation.
We plan, design, manage and implement an integrated strategic approach to commercial collaborations in marine
biotechnology for “new-to-science” biodiscovery, from scientific research and development, biotechnological processing
and production through to commercialisation. We collaborate in commercial partnerships for marine scientific research to
develop and commercialise “new-to-science” marine biotechnology products for sales to commercially viable and
emerging global markets, predominantly in USA, Asia, Europe, Scandinavia and South America and selected emerging
markets worldwide.
We strategize, prioritise, organise and coordinate commercial collaborations in consortiums between significant partners,
private sector entrepreneurs, private sector investors and biotechnology companies, scientific research and development
experts. We consult and negotiate the necessary and compulsory components, formalities, and protocols. We coordinate
multi-faceted national and regional, sub-regional, inter-regional and international complex structural and lateral synergies
for each individual commercial activity between significant partners, consortiums in commercial collaborations.
We specialise in a range of marine biotechnology products including beauty products, cosmetics, nutraceuticals, vitamins,
minerals, supplements, hair and beauty products, medicinal and pharmaceuticals, food additives, preservatives,
household products using enzymes, agricultural and the multitude of associated industries. We integrate our global
commercialisation strategies to suiteach marine biotechnology product. This includes authentication, efficacy, packaging,
labelling compliance with each individual countries compulsory Patent requirement for health and safety and relevant
international export market entry requirements, relevant Trade Agreements and comply with regulatory authorities for
international compulsory World Trade Organisation biotechnology products standards from production and
manufacturing to global marketing, advertising and logistical global supply chain distribution.
We work with a broad range of significant partners and associates in commercial development in the Marine
Biotechnology industry. With a multitude of professionals working in associated sectors of marine biotechnology,
including Innovation and increased efficiency, efficacy, health and safety measures and the best scientific research
methodologies and technologies with applications and uses to accelerate the quality and effectiveness of “new-to-
science” marine biotechnology products.
MANAGEMENT CONSULTING IN PRIVATE SECTOR COMMERCIAL COLLABORATIONS & CONSORTIUMS WITH
THE SOUTH PACIFIC REGION SIGNIFICANT PARTNERS
We initiate, plan, design, develop, implement, manage and coordinate, potential commercial collaborations with
significant partners in marine biotechnology products industry and the entire process from biodiscovery to
commercialisation, through integrated, multi-faceted strategies and synergies of mutually agreed cooperation and
commercial collaboration including:
Commercially Viable Enterprises in Marine Biotechnology Product Development
Consultations for potential commercial collaboration in marine biotechnology development
Collaboration, development, planning and implementation of various activities to achieve definitive action in
commercially viable propositions from the marine biotechnology private sector industry
Commercial Collaborations, Partnerships and Consortiums in Marine Biotechnology in the South Pacific
Entrepreneurial Private Sector Initiatives in Collaborations for Marine Biotechnology Commercial Products
Commercial Feasibility Studies and Assessments for Prospective Significant Partners and Investors
Consortium Stakeholders Projects including Design, Management and Implementation
Business Management and Administration, Audits, Transparency and Accountability
Business Intelligence and Industry Trends for Commercial Marine Biotechnology Products
We advise prospective commercial partners in the development and formulate a commercial collaborative contract to
negotiate with Significant Partners the South Pacific region. We bring together leading academics, scientific research
and development industry, the Private sector, Small to Medium Size Enterprises (SMEs), Entrepreneurs, leading
Biotechnology Companies and Associates from Marine Biotechnology Organisations to facilitate and implement
strategies and management plans for the development of commercial “new-to-science” marine biotechnology
products.
We develop, prepare, consult, adviseand negotiate recommendations for commercial contractual collaborations.
We facilitate consultations and negotiations in conjunction with expert specialised professional scientific, institutional
and expert advice to ensure compliance with all regional compulsory requirements, relevant protocols, Licences,
Permits, Intellectual Property Rights (IPRs), Patents WTO Trade, Environment and Biotechnology international
regulations, including processing, packaging and labelling to international standards. This is essentially a commercial,
private sector export-driven business.
We integrate and comply with the South Pacific Region’s complex, compulsory synergies in National and Regional Legal
and Regulatory Mechanisms and Frameworks including Regional and Multi-Lateral Agreements and Conventions including
the United Nations Convention on the Law of the Sea (UNCLOS) and the Convention on Biological Diversity (CBD), the
InternationalSeabed Authority (ISA) and Global Ocean Spatial Planning and uses and the multitude of South Pacific Region
compulsory regulations including Environmental ImpactAssessments (EIAs) and compulsory EnvironmentalRegulations.
We cover an extensive rangeof components necessary and compulsory RegionalLegal and Regulatory Frameworks
consistentwith Trade Related Intellectual Property Rights (IPRs), Certificateof Origin and WTO regulations for contract
formulation to negotiation.
SOUTH PACIFIC REGION PRIVATE SECTOR MARINE BIOTECHNOLOGY SCIENTIFIC RESEARCH
AND DEVELOPMENT
MARINE BIOTECHNOLOGY RESEARCH AND DEVELOPMENT & PRIVATE SECTOR INVESTMENT
We are experts in our field and understand the importance of marine biotechnology research and development (R & D).
We have local and international specialists and experts, technologies and resources strategically collaborating in a multi-
disciplinary and holistic approach to marine biotechnology research and development, as an essentially important part of
the bio-discovery process. Based on the multitude of multi-sectoral disciplines associated with scientific marine research,
from collection processes, multiple screening and research and development methodologies.
These new technologies, have completely transformed scientific research and “new-to-science” discovery processes from
10 – 20 years of research in the laboratory, to a few seconds, with marine biotechnology products commercialised and
patented and on the retail shelves within potentially 1 – 2 years.
The impact of these innovations in the scientific and biotechnology community has enabled faster, effective, safe and
healthy quality marine biotechnology products. The number of patents in marine biotechnology products is increasing, as
the ratio of new products or products with novel uses and characteristics. Combined with other biotechnology equipment
has become more commercially viable to prospective investors and collaborators, as emerging technologies and
efficiencies make product discovery to production and manufacturing effectively and profitable.
SOUTH PACIFIC REGION MARINE BIOTECHNOLOGY RESEARCH & DEVELOPMENT
We manage and facilitate the discovery of “new-to-science” ingredients sourced from biologically rich and diverse
endemic marine ecosystems represents one of the most promising and highly outcomes of marine biotechnology
research, development and discovery of “new-to-science” products with a variety of commercial and novel applications
including environmental sustainability.
This includes collaborative innovations in marine biotechnology development, genomics, molecular and chemical
engineering, bioreactor design bioprocess engineering and transgenic production, combined with efficient processing and
production applications necessary to meet the needs of both discovery and bulk production of novel marine bio products.
Working in partnership with a global connections inventing a new generation of tools and processes that will enable a
greater understanding of the ocean and its resources and lead to the discovery of new bio products for the future, and
designing methods for their sustainable development, production and manufacturing.
Biochemical produced by marine invertebrates, algae and bacteria, are very different than those from related terrestrial
organisms and offer greater potential as new classes of medicines. In addition to new medicines, other uses for marine-
derived compounds include: Cosmetics (algae, crustacean and sea fan compounds), Nutritional Supplements (algae and
fish compounds), artificial bone (corals), and Industrial Applications (fluorescent compounds from jellyfish, novel glues
from mussels, and heat resistant Enzymes from deep-sea bacteria).
THE SOUTH PACIFIC REGION MARINE BIOTECHNOLOGY INDUSTRY PRIVATE SECTOR INITIATIVES AND
COMMERCIAL COLLABORATIONS
We make your bio-discovery and research and development process moreefficient and results driven. Using the latest
innovative analytical instruments, essentiallaboratory equipment supplies and bio-tools for researchers working in the
fields of antibodies, cultures, biology, electrophoresis, genomics, proteomics and others for new-to-sciencemarine
biotechnology discovery research and development (R&D) technologies. These technologies fasttrack the efficiency at
which new to science gene species can be identified and scientifically characterised for their application and uses and
sector of marine biotechnology authenticated for scientific efficacy and applications for commercial development into the
“new biotechnology product”.
This will accelerate your application with our complete portfolio of analytical technologies and laboratory products
spanning research, discovery and production. With a strong focus on scientific research and development enabling
scientists and laboratories advancing “new-to-science” bio-discoveries with novel tools to innovate and support their
pioneering efforts. R&D strategies navigate every step of the product development process to bring new products to
market with more predictability and efficiency and technologies to authenticate their efficacy. With integrated strategies
to maximise value adding potential, includes bio-additives applications with other existing products. We minimise risk
with up to date, accurate analysis and commercial insights in the development planning and implementation phases. We
provide practical strategies from world-class experts
 and work with the new realities compliance with ethical and
regulatory standards to global commercialisation as part of our Private Sector Commercial Collaboration.
SOUTH PACIFIC MARINE SCIENTIFIC RESEARCH & DEVELOPMENT & COMMERCIALISATION OF
MARINE BIOTECHNOLOGY PRODUCTS
With successful “new-to-science” marine genetic resources, their microorganisms and the capabilities of the latest
innovations in multiple screening of sampling, interpretation of characterisation and potential scientific applications and
uses, screen with more in depth and higher probability of success. Utilising biotechnology research and development
technologies, for a multitude of scientific purposes in the development of new products, including production and
manufacturing technologies and capabilities.
We only work with established and innovative outstanding leading Academics, Scientists, Researchers and Biotechnology
Product developers. With years of relevant experience in the South Pacific Region and internationally, up to date with the
latest industry developments including innovations and advances in technologies used for various applications in Marine
Biotechnology Research and Development (R & D), necessary. Coupled with a genuine understanding of the challenges,
needs and objectives of our prospective clients, ensures we deliver insightful and strategic solutions in a cost effective
commercial and efficient way.
The uniqueness of the endemic marine biological environments of the South Pacific Region for marine biotechnology
industry is substantial and an economic indicator of the unprecedented commercial potential of the unique marine
genetic resources of the South Pacific Region.
MARINE BIOTECHNOLOGY INDUSTRY POTENTIAL FROM THE SOUTH PACIFIC
Marine biotechnology involves the discovery and application of products and processes derived from marine organisms.
Marine biotechnology's promising future reflects the tremendous biodiversity of the world's oceans and seas. The oceans
and seas cover more than three-quarters of the earth's surface. Marine organisms accountfor a major share of the Earth's
biological resources.
Most major groups of living organisms are primarily or exclusively marine. Science has identified close to 200,000 species
of marine algae, animal bacteria, fungi and viruses, with perhaps as many as four times this number of organisms as yet
unidentified. Tropical marine environments harbour an especially wide diversity of animals and plants.
The scientific potential of marine biotechnology is reflected in the multitude of marine organisms’ and their unique
qualities based on need to adapt themselves to the extremes of temperature, pressure and darkness that are found in the
world's seas. The demands of the marine environment have led these organisms to evolve unique structures, metabolic
pathways, reproductive systems, and sensory and defence mechanisms.
The potential to generate significant wealth and the equitable and sustainable management of these new revenue
streams, capitalising on new employment opportunities and other indirect economic benefits is of critical importance.
Opportunities for commercial collaborations, partnerships, consortiums with the South Pacific Region.
SOUTH PACIFIC REGION MARINE BIOTECHNLOGY PRODUCTS INDUSTRY COMMERCIAL
POTENTIAL & EXPORT DRIVEN GLOBAL MARKET INDICATORS
MARINE BIOTECHNOLOGY PRODUCTS IN THE COSMETICS INDUSTRY
MARINE BIOTECHNOLOGY PRODUCTS IN THE NUTRACEUTICALS INDUSTRY
MARINE BIOTECHNOLOGY PRODUCTS FOOD PROCESSING & PRESERVATION
MARINE BIOTECHNOLOGY PHARMACEUTICALS VITAMINS & SUPPLEMENTS
GLOBAL CORPORATE STRATEGIC ALLIANCES IN THE MARINE BIOTECHNOLOGY INDUSTRY & GLOBAL SALES
AND MARKETS
We are the PRIVATE SECTOR with an Strategic Global Commercial expert connections in all fields of Marine Biotechnology
from Academics, Scientific Research and Development Experts, Biotech Companies, Marine Biotech Technologies,
Innovative Financial Arrangements Options and Innovative Marine Biotechnologists and Corporate Strategic Alliances and
high-profile media and marketing connections, to raise the profile and brand power to maximise global sales using our
global marine biotechnology products branding and “niche marketing” strategies. Our global established networks and
spheres of influence include our networks in 180 countries including focal points:
 AUSTRALIA & NEW ZEALAND: Surfers Paradise, Brisbane, Sydney, Melbourne, Australia
 SOUTH PACIFIC REGION: Apia, Samoa, Suva, Fiji, Noumea, New Caledonia, Tahiti (all Pacific Island
Countries)
 ASIA: Hong Kong, Beijing, China, Singapore and selected Asian countries
 EUROPE: London, (UK) Dublin, Ireland, Edinburgh and Glasgow Scotland, Amsterdam, Holland, Paris,
France, Geneva, Switzerland, Bonn, Germany, Vienna, Austria
 USA & CANADA: Ontario, Canada, New York, San Diego, San Francisco, California, Washington, USA
 SOUTH AMERICA: Rio de Janeiro, Sao Paolo, Brazil, Uruguay, Chile, Argentina
 SCANDANAVIA: Copenhagen, Denmark, Stockholm, Sweden, Oslo, Norway, Finland
GLOBAL COMMERCIALISATION FOR DIRECT SALES TO INTERNATIONAL MARKETS
GLOBAL COMMERCIALISATION OF “new-to-science” MARINE BIOTECHNOOGY PRODUCTS
Consultancy and Management Services integrated into our collaborative Agreements include planning, design and direct
sales for “new-to-science” Marine Biotechnology products for Global Commercialisation include:
 Branding
 Marketing
 Advertising Campaigns
 ProductLaunches and Trade Shows
 Direct Marketing and Sales to international markets
 Raising the Profile of each new Marine Biotechnology Productto
the global marketplace via a rangeof unique marketing strategies
to the widestaudience of consumers possible
COMMERCIAL COLLABORATIONS AND CONSORTIUMS WITH THE SOUTH PACIFIC REGION SIGNIFICANT
PARTNERS IN MARINE BIOTECHNOLOGY INDUSTRY COMMERCIAL CONTRACTUAL AGREEMENTS
We bring together leading academics, scientists and research and development industry, private sector and biotechnology
companies and Small to Medium Size (SMEs), Entrepreneurs, leading Biotechnology Companies and Associates from
marine biotechnology organizations to encourage the development of commercial marine biotechnology.
We develop, prepare, consult positions and advise and negotiate recommendations for commercial contractual
collaborations.
Facilitate consultations and negotiations in conjunction with expert specialised legal advice to ensure compliance with
all regional compulsory requirements, relevant protocols, licences, permits, intellectual property rights (IPRs), patents,
Biosecurity and WTO regulations
Advise prospective commercial partners in the development and formulate a commercial collaborative contract to
negotiate with Significant Partners.
We integrate the South Pacific Region’s complex, synergies in Regional and National Legal and Regulatory Frameworks for
compliance.
We cover an extensive range of compulsory components necessary for contract formulation to negotiation.
COMMERCIAL COLLABORATIONS WITH SIGNIFICANT PARTNERS IN THE SOUTH PACIFIC REGION FOR
MARINE BIOTECHNOLOGY PRODUCTS AND GLOBAL MARKETS
Prospective collaborative partnership initiatives in marine biotechnology commercial research and development activities
and projects (and each of its components) have the following details: (variable) an example or guideline:
1. Commercial Feasibility studies and Commercial Strategy Recommendations
2. Projectinformation (Description of proposed commercialactivity, aims, objectives, resources, input/output
and legalities)
3. Companies using research on genetic resources (Biotech Company)
4. Research organizations working with companies (R & D Institutions)
5. Parties approving/sponsoring relevant research (Financial Arrangements)
6. Access Benefit sharing terms (Incentives and Investment Strategy)
7. Patents or other forms of Intellectual Property (IPRs) for Licencing (mutual protection)
8. Common and scientific names of the source organism (Certified)
9. Geographical area where the organism was collected (Authenticated)
10.Publications (depending on Private or Public Arrangements and Contractual)
11.Databases (as per Contractual Mutual Agreements for Private Funding and other Agreed Arrangements)
12.Commercialized products (Commercial Marketing and Sales Arrangements
With world-class experienced industry experts and specialists, our integrated consulting teams bring you sustainable
implementable strategies that integrate a multitude of relevant components in the complex global marine biotechnology
industry and consistent with World Intellectual Property Rights (WIPO), Trade Agreements, Regional and Multilateral
Environmental Agreements (MEA) s and World Trade Organisation (WTO) standards. 
It is essentially consistent relevant
National and Regional South Pacific Region Private Sector and Transnational Businesses and International Governments;
Regional Organisations include the following compulsory components:
1. Precautionary Principle
2. Prior Informed Consent
3. Traditional Knowledge (TK)
4. Interpretation
5. Definitions
6. Environmental ImpactAssessments(EIA)
7. Multi-lateral Environmental Agreements (MEA)
8. Regulatory Legal Rules and Frameworks (RLRF)
9. Commercial Partnerships in Areas beyond National Jurisdiction
10.Biotechnology Health and Safety Standards and Biosecurity
11.Certificate of Origin (CO)
12.Access and Benefit Sharing (ABS)
13.Mutually Agreed Terms (MAT)
14.Intellectual Property Rights (IPRs)
15.Material Transfer Agreement(MTA) and IPRs
16.Best Standard Practises (BSP)
17.Intellectual Property Rights (IPRs) and
18.Trade Related Intellectual Property Rights (TRIP)s
19.Patents, Royalties and Revenue Arrangements
20.Licencing and Co-Licencing Collaborative Arrangements
21.Trade Related Intellectual Property Rights (TRIPS) and Patents
22.Biosecurity and Monitoring Mechanisms throughoutthe process
23.Global Insurancefromstartto Completion
24.Legal Mechanisms to ensure Compliance and Bio- security Enforcement
Including a range of other relevant components depending on the complexity and variability of the Commercial
Agreement.
Collaboration in Marine Biotechnology Industry Development Activities are already mapped out and reaffirmed in both
the Convention on Biological Diversity (CBD) and the United Nations Convention on the Law of the Sea (UNCLOS), and the
United Nations International Seabed Authority (ISA) compared to other geographic biologically diverse parts of the world.
In a unique situation that allows the mutually complementary established frameworks for collaboration to be
implemented into a series of Actions Plans with mutual economic benefit, and potentially commercially viable enterprise
opportunities for all stakeholders
Legally binding provisions as referred to in the United Nations Convention on the Law of the Sea (UNCLOS) and the United
Nations Convention on Biological Diversity (CBD) With specific reference to the following Articles contained in the United
Nations Convention on the Law of the Sea (UNCLOS) and the United Nations International Seabed Authority (ISA)
consistent with South Pacific Regional Conventions integrated into the final text of all commercial collaborations includes:
 Maps of UNCLOS regions and Legal Status
 Limits of the Territorial Seas and Jurisdiction
 Ownership and Control
 Exclusive Economic Zones (EEZs)
 Regime of the Island
 Principles Governing the Area
 Development of Resources of the Area
 Protection and Preservation of the Marine Environment
 Global and Regional Cooperation and InternationalTrade and Investment
 Technical Resources, Technology Transfer, Training and Capacity Building
 Monitoring and Environmental Assessment
 Marine Scientific Research within the Consistentwith the South Pacific’s Global Ocean
Spatial Planning
 Conduct of Scientific Research
 Scientific Research Institutions or Equipment in the Marine Area
 Development and Transfer of Marine Technology
 General Provisions of InternationalCooperation and Collaboration in Marine
Biotechnology
Consulting on the feasibility of internationally agreed guidelines on environmental regulations, health and safety
in marine biotechnology we integrate:
 Risk assessment and risk mitigation and management and
the feasibility of guidelines which facilitates national
legislation
 Clarification of the relationship between the legal framework of Intellectual Property Rights (IPRs) and relevant
Conventions referring to partnerships, collaborations in Marine Biotechnology the United Nations Convention on
the Law of the Sea (UNCLOS) and the Convention on Biological Diversity (CBD) and the International Sea Bed
Authority (ISA) and the Pacific Island Countries and Pacific Island Country Territories with their security from
Australia, New Zealand, France and the USA
 Further develop, as necessary, the existing safety procedures to promote scientific development and categorization
in the areas of risk assessment and risk management (information requirements; databases; procedures for
assessing risks and conditions of release; establishment of safety conditions; monitoring and inspections, taking
account of ongoing national, regional and international initiatives and avoiding duplication wherever possible
 Compile, update and develop compatible safety procedures into a framework of internationally agreed principles as
a basis for guidelines to be applied on safety in biotechnology, including consideration of the need for and feasibility
of an international agreement, and promote information exchange as a basis for further development, drawing on
the work already undertaken by international or other expert bodies
COMMERCIAL COLLABORATIONS IN MARINE BIOTECHNOLOGY INDUSTRY
We focus on predicting, measuring and managing, minimizing and preventing risk and integrate it into adapting to
changing circumstances. We create a fully integrated enterprise commercial models Collaborations and increased sales
and profits, Revenue Recognition, Payment of Royalties as a Guidelines and the latest Global Biotechnology Industry
Trends and Updates and others including adapting to a globally competitiveness.
A Guideline for a Model Commercial-In-Confidence Collaborative Contractual Agreement would integrate, depending on
the nature and complexity of the Contract the following “interpretations” and “definitions” integrated to the
recommended model structure and strategy of commercial collaborations in Marine Biotechnology Product Development
and Commercialisation and Global Sales “Co-Licencing integrated as Co-Licencing Arrangements in all Commercial
Collaborations.
A Guideline for a Contract and Commercial Global Strategy aims to maximise global sales to achieve maximum profits from
a Private Sector Export Driven Commercial Collaboration with multiple benefits. These are both economic and
environmentally sustainable and responsible benefits.
Our strategies combine and specify the structure of collaborations and commercial mutually agreed distribution of profits
depending on preparation, research and development duration and cost itemised, discovery and commercial applications
research and development, production processes and methodologies. Innovative technologies for volume production,
appropriate labelling for international markets and appropriate export entry regulations and marine biotechnology
products market entry.
Our strategies integrate the following necessary components and specifications to succeed in a globally competitive
environment:
 Collaborative Arrangements for Licences & Mutual Agreements on all Patents
 IPR&D Assets and Intellectual Property Rights (IPRs) on Patents Agreements
 Collaboration Commercial Agreements Specified and Detailed
 Relevant Trade Agreements
 Revenue Recognition and defined Arrangements for ProfitAccountability
 Material Patents
 Research and Development
 Discovery and Compliance with Regulatory Processes and Authorities
 Production and Manufacturing
 Packaging, Labelling and compliance with World Regulatory Standards
 Commercialisation Strategies for each new marine biotechnology arrangement
 Global Branding and Marketing to maximise global sales and profits
 Arrangements for Distribution of Royalties and Payments to Participating Parties
to the Contractual Agreement and Audited Accountability
We utilise a model that integrates the Commercial Cycle, fromBioprospecting, R&D towards bio-discovery of “new to
science” marine biotechnology products by taking a holistic approach. Fromscientific marine research, bioprospecting
through to biodiscovery and commercial application and uses through to production to global chain-supply distribution
models that succeed, without any “fail-fast” issues or risks thatis linear, slow, inflexible, expensiveto one that is fast,
adaptive, cost-efficient, innovative. Consortiums areprivate sector financed with commercially driven towards quality,
efficiency, effectiveness, efficacy, health and safety measures and results-oriented rand is committed to measured profit
sharing structures, based on commercial probability and results with all stakeholders.
We ensureRevenue Recognition and Royalty Payments and distribution of benefits to collaborators integrated into each
strategy as included in Licencing Specifications on all Licences and Patents consistentwith World Trade Organisation
(WTO) and the World Business Organisation and InternationalChamber of Commerce (ICC) recommendations and in
commercial consortia in the Marine Biotechnology Patents and Licencing Collaboration Agreements.
COLLABORATION WITH SIGNIFICANT PARTNERS AND CO-LICENCING ON PATENTS AND DEVELOPMENT AND
PRODUCTION PROCESSES
We integrate the following compulsory components in any Commercial Collaboration with regards to the Nature of
Collaboration
Nature of Collaboration Arrangements and Mutually Agreed Contractual Specifications:
1. Licences
2. Development
3. Commercialization
4. Manufacturing
5. Global Marketing and Advertising
6. Global Product launches and Product Promotion
7. Global Distribution and Supply Chain Logistics
These are specifications and details relating to:
1. The identity of the other party in the arrangement
2. The products being developed, as applicable
3. Any amounts paid or received to date under the arrangement (including up-front licensing fees and payments)
4. Under each arrangement, aggregate potential payments to be made or received
5. The existence of royalty provisions, royalty rates (or ranges within defined percentages if tiered) and any sales
thresholds related to rates
6. Duration and termination provisions, including payments the registrant may be required to make in the event of
termination
ND - Not disclosed:
1. Collaboration Arrangements with Significant Partners.
2. Disclosed only the accounting policies used for collaboration arrangements.
3. Collaboration arrangements with two significant partners, Silent Partners, Equity and Private Capital
Entities must include a separatesection for Collaboration Arrangements, which were disclosed in many places in MD&A or
in notes to the financial statements. Including:
1. Collaboration Arrangements with Significant partner.
2. Disclosed in Aggregate in the Notes to the Financial Statements.
3. Disclosures in the notes to the financial Statements of Total Amounts Received and Paid during the fiscal year.
4. Disclosed for Major Collaboration Partners in Agreements.
We integrate the following as part of our commercial strategies for global success:
 Companies large and small approaches to innovation aims
 R&D moreefficient through initiatives (private, companies and research institutions)
 Standards for recording clinical, qualifying testing sites and training
 Technology Transfer, Capacity Building for on-site local Trainers in the South Pacific and
internationally
 Competitive partnerships and Collaborations and Consortia, to conduct predictive modelling
assessments and strategies for success
The Standard Guideline for any potential Commercial Collaboration with Significant Partners Contractual Compulsory
components integrated into facilitating access to Licences referring to Co-Licencing on all Patents and Trade Related
Intellectual Property Rights (TRIPS) including Mutually Agreed Benefits Acquired from a Commercial Marine Biotechnology
“new-to-science” product Financial Arrangements. These are integrated and specified into Patents and Co-Licencing
Commercial Contractual Agreements with Significant Partners and Collaborative Arrangements.
LICENCES AND CO-LICENCING IN PATENTS ON COMMERCIAL COLLABORATIONS
 Licencing and Co-Licencing Arrangements and Patents mutually agreed obligations and commitments
 R&D services and specifications including process, duration, resources expenditure, commercialnew marine
biotechnology product
 Patents and Co-Licencing Collaboration Agreements
 Manufacturing and Supply Chain Agreements
 Participation in joint steering and development committees.
 Monitor and Audit Amountof productsales by country and accounts receivable outstanding by each country
MATERIAL PATENTS CONTRACTUAL CO-LICENCING ON PATENTS
AGREEMENTS & OBLIGATIONS
Arrangements regarding material patents and relevant collaborative arrangements including Licencing mutually agreed
obligations and Licencing Specified commercial collaboration Contractual Arrangements.
 Specifications of Arrangements and mutual obligations for the products or technologies that relate to the Patent
 Areas beyond National Jurisdiction in which the Patent is sourced “Certificate of Origin” acquired and granted and
Co-Licencing Commercial Arrangements referring to Patents and Certificate of Origin
 Expiration date, identification of patents subjectto legal proceedings and Patent obligations including co-licencing
arrangements specified in relevant documentation
We IntegrateAdditional Information explaining ways the IPR&D Assets were:
 Verified “in-situ “with “Certificate of Origin” and Patent, Intellectual Property Rights (IPRs) Licencing and Co-
Licencing on Patents Mutual Agreements on an individual basis
 Agreements regarding the control over the amountof information disclosed
 No. Of IPR&D assets, or a limited number of IPR&D assets recorded
In order to gain a better understanding of the effects and expected effects of your research and development activities on
results of operations and financial position the following additional information for significant products in research and
development is provided:
 Specified and Itemised duration and costs incurred during each period presented.
 Maintaining any research and development costs with quantitative or qualitative disclosurethatindicates the
amount of the company’s resources being used on the project.
 Nature of efforts and steps necessary to complete the product.
 Risks and uncertainties associated with completing development, extent and nature of additional resources that
need to be obtained if currentliquidity is not expected to be sufficient to complete the product.
Revenue Recognition Requirements:
 Nature of each revenue deduction, along with information about the key terms of material arrangements or
agreements that influence the estimate of each deduction as of each balance sheet date
 Levels of inventory in distribution channels
 Estimated remaining productshelf lives
 Shipments of productmade as a result of incentives or in excess of the customer’s ordinary demand
 Quantitative information related to qualitative factors a registrant considers when it estimates each revenue
deduction
 The underlying business reasons for materialperiod-to-period fluctuations for each type of reduction of gross
revenue, including the effect that changes in estimates have on revenues and obligations
FINANCIAL ARRANGEMENTS FOR COMMERCIAL COLLABORATIONS AND GLOBAL CORPORTATE STRATEGIC
MONITORING MECHANISMS AND COMPLIANCE
We integrate Financial Management Strategies for Execution and Implementation of Global Revenue Recognition
Mechanisms, facilitating execution of Royalties and mutually Agreed Financial Structures and Distribution among
Stakeholders or Collaboration Arrangement Disclosures and Payments
 Financial Arrangements and strategies regarding private and public disclosures related to collaboration
arrangements.
 Specified list of items subjectto disclosureamong Collaborating Consortia
 Identification of the “
other parties” in the “Commercial-In-ConfidenceContractualArrangement”
 Products being developed in Marine Biotechnology Industry and their potential applications and use
 Amounts paid or received under the arrangements
 Aggregate payments to be paid for each biodiscovery of “new-to-science” marinegenetic resources and Patent
Arrangements
 Provisions of royalty paymentrates and global market sales by sector, country and volumeof production and sales
 Annual maintenance fees, including duration and termination provisions and payments the registrantmay be
required to make in the event of termination.
 Payment obligations under collaboration arrangements mustalso list any potential payments in the contractual
obligations and mechanisms for compliance
RESEARCH AND DEVELOPMENT (R & D) EXPENSES FOR EACH “new to science”
MARINE BIOTECHNOLOGY PRODUCTS DEVELOPED
The Marine Biotechnology Industry incurs significantexpenses for R&D activities to develop a limited number of new
marine biotechnology products in relation to the number of compounds developed.
 R & D spending of by project segment, stage of development itemised within the context of the total strategy
commercial process
 Approvals by international Governments for marketentry into predominantly Asia, Europe, UK and USA
 The time it took compared to estimates to complete clinical tests and compulsory regulatory approvals
 The Impactof R & D Projects and the company’s futureoperations and/or liquidations
 Audited Research & Development Expenses specifications
 Research and Development Resources and Equipment Expenses and Logistical Arrangements and Structures
 Monitoring, evaluation agreed strategies and mechanisms and Biosecurity Arrangements
 Related Costs incurred to date compared with estimated expenses including insuranceand monitoring mechanisms
 Estimated Completion Dates and final completion dates referring to commercially viable new marine biotechnology
products
 Completion Costs and Capital Requirements and estimated start and completion specified in Licencing Arrangement
 The Extent to which a Project’s Success is Assessed Depending on parties other than the registrant
 Discussion of the project’s phases and a description of the natureof the products in the pipeline
 Providequantitative or qualitative disclosures thatdescribe the amount of resources being used on each project or
group of projects
COMMERCIAL COLLABORATIONS REVENUE RECOGNITION AND ROYALTIES PAYMENTS AUDITED &
ACCOUNTABILITY PROCEDURES
 Revenue as they relate to obligations based on Contractual Co-Licencing mutual agreements
 Revenues and Royalties when recognizing revenue for the sale of a new, novel or unique products
MARINE BIOTECHNOLOGY INDUSTRY REGULATIONS AND COMPLIANCE WITH REGULATORY AUTHORITIES,
TRADE AGREEMENTS, WTO AND SUPPLY-CHAIN LOGIGISTICS FOR GLOBAL SALES AND MARKETING &
DISTRIBUTION
Providethe following information aboutacquired Licencing and Patents Arrangements for Intellectual Property Rights and
Research and Development Processes for biodiscovery, scientific Research and Development, Specialised Marine
Biotechnologist and other necessities depending on the complexity and duration
InnovativeMethodology Commercial Applications Development and Productprocesses for production and manufacturing,
packaging, labelling, authenticity, compliance with regulatory authorities for each sector in export market destination with
specifications regarding labelling and coding, monitoring, global chain-supply logistics for distribution to global markets.
Commercialisation Processes and formalities for integrated collaboration on Global Branding and Global Marketing
Strategies to Maximise sales to consumer markets.
Global Branding and Marketing materials, advertising, multi-media, globalbusiness strategic networks for a productis new,
novel or unique in some aspect integrating into the Global “niche-marketing strategy” depending on the marine
biotechnology “new to science” product. Recent press releases and productlaunches and integration into Global Strategic
Trade Shows and Exhibitions in the Marine Biotechnology and Associated Industries
 Latest global consumer market trends, sales and demand in the specific marine biotechnology
products
 Determine whether selling prices arefixed or determinable in order to recognizerevenue
upon
 Delivery of products to customers and cost-effectivechain supply delivery to global markets
 Financial Statements audited and monitored

Marine Biotechnology ProductPerformance:
 Profitearnings specifications by country, volumeand net sales
 Description of earnings fromglobal sales
 Breakdown of calculation of income
 Audited Explanation of the purposeof the earnings figure
 Audited Explanation for significant earnings highlighted
Risk Management and Mitigation:
Descriptions of Key Risks of Industry specific risks integrated includes
 Intensecompetition around branded products
 Costly and highly uncertain natureof research and development
 Competition fromlower-priced generic products
 Loss or expiration of intellectual property in the near future
 Unexpected developments related to safety or efficiency of product
 Pipeline productivity and competition — ability to continuously develop or replace products
 Pricing and access pressures
 Currentand future product liability claims
 Potential exposureto government price controls
 Ability to obtain and maintain approvalfor products
 Potential noncompliance issues and scrutiny fromTGA, FDA and other regulators
 Adverseeffect fromchanges in laws and regulations
 High dependency of revenues, cash flows and earnings on protections given by Patents
General Risks:
 Manufacturing and supply-chain difficulties
 Reliance on third-party and outsourcing arrangements
 Financial distress and bankruptcies experienced by significant customers
 Economic factors, including inflation and fluctuating interest rates and currency values
 Interruptions of computer systems, impairing ability to conduct business
 Vulnerability of key company products, and their significant profits and cash flows, to adverse
market events
 Failure to realize the anticipated benefits of strategic initiatives and acquisitions
2

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2

  • 1. LISA-MARIE CRICHTON & ASSOCIATES MARINE BIOTECHNOLOGY MANAGEMENT CONSULTING FOR COMMERCIAL COLLABORATIONS WITH SIGNIFICANT PARTNERS IN THE SOUTH PACIFIC REGION
  • 2. MANAGEMENT & CONSULTING IN PRIVATE SECTOR COMMERCIAL COLLABORATIONS IN MARINE BIOTECHNOLOGY NEW PRODUCT DEVELOPMENTWITH SIGNIFICANT PARTNERS IN THE SOUTH PACIFIC REGION A Private Sector Marine Biotechnology Management Consulting business, working in collaboration with Significant Partners from the South Pacific Region and leading local and International Experienced World-Class Experts & Associates. We collaborate in innovative, commercially viable, sectors of the Marine Biotechnology industry in marine biotechnology product scientific research, bioprospecting towards the discovery of “new-to-science” products for development and commercialisation. We plan, design, manage and implement an integrated strategic approach to commercial collaborations in marine biotechnology for “new-to-science” biodiscovery, from scientific research and development, biotechnological processing and production through to commercialisation. We collaborate in commercial partnerships for marine scientific research to develop and commercialise “new-to-science” marine biotechnology products for sales to commercially viable and emerging global markets, predominantly in USA, Asia, Europe, Scandinavia and South America and selected emerging markets worldwide.
  • 3. We strategize, prioritise, organise and coordinate commercial collaborations in consortiums between significant partners, private sector entrepreneurs, private sector investors and biotechnology companies, scientific research and development experts. We consult and negotiate the necessary and compulsory components, formalities, and protocols. We coordinate multi-faceted national and regional, sub-regional, inter-regional and international complex structural and lateral synergies for each individual commercial activity between significant partners, consortiums in commercial collaborations. We specialise in a range of marine biotechnology products including beauty products, cosmetics, nutraceuticals, vitamins, minerals, supplements, hair and beauty products, medicinal and pharmaceuticals, food additives, preservatives, household products using enzymes, agricultural and the multitude of associated industries. We integrate our global commercialisation strategies to suiteach marine biotechnology product. This includes authentication, efficacy, packaging, labelling compliance with each individual countries compulsory Patent requirement for health and safety and relevant international export market entry requirements, relevant Trade Agreements and comply with regulatory authorities for international compulsory World Trade Organisation biotechnology products standards from production and manufacturing to global marketing, advertising and logistical global supply chain distribution. We work with a broad range of significant partners and associates in commercial development in the Marine Biotechnology industry. With a multitude of professionals working in associated sectors of marine biotechnology, including Innovation and increased efficiency, efficacy, health and safety measures and the best scientific research methodologies and technologies with applications and uses to accelerate the quality and effectiveness of “new-to- science” marine biotechnology products.
  • 4. MANAGEMENT CONSULTING IN PRIVATE SECTOR COMMERCIAL COLLABORATIONS & CONSORTIUMS WITH THE SOUTH PACIFIC REGION SIGNIFICANT PARTNERS We initiate, plan, design, develop, implement, manage and coordinate, potential commercial collaborations with significant partners in marine biotechnology products industry and the entire process from biodiscovery to commercialisation, through integrated, multi-faceted strategies and synergies of mutually agreed cooperation and commercial collaboration including: Commercially Viable Enterprises in Marine Biotechnology Product Development Consultations for potential commercial collaboration in marine biotechnology development Collaboration, development, planning and implementation of various activities to achieve definitive action in commercially viable propositions from the marine biotechnology private sector industry Commercial Collaborations, Partnerships and Consortiums in Marine Biotechnology in the South Pacific Entrepreneurial Private Sector Initiatives in Collaborations for Marine Biotechnology Commercial Products Commercial Feasibility Studies and Assessments for Prospective Significant Partners and Investors Consortium Stakeholders Projects including Design, Management and Implementation Business Management and Administration, Audits, Transparency and Accountability Business Intelligence and Industry Trends for Commercial Marine Biotechnology Products
  • 5. We advise prospective commercial partners in the development and formulate a commercial collaborative contract to negotiate with Significant Partners the South Pacific region. We bring together leading academics, scientific research and development industry, the Private sector, Small to Medium Size Enterprises (SMEs), Entrepreneurs, leading Biotechnology Companies and Associates from Marine Biotechnology Organisations to facilitate and implement strategies and management plans for the development of commercial “new-to-science” marine biotechnology products. We develop, prepare, consult, adviseand negotiate recommendations for commercial contractual collaborations. We facilitate consultations and negotiations in conjunction with expert specialised professional scientific, institutional and expert advice to ensure compliance with all regional compulsory requirements, relevant protocols, Licences, Permits, Intellectual Property Rights (IPRs), Patents WTO Trade, Environment and Biotechnology international regulations, including processing, packaging and labelling to international standards. This is essentially a commercial, private sector export-driven business. We integrate and comply with the South Pacific Region’s complex, compulsory synergies in National and Regional Legal and Regulatory Mechanisms and Frameworks including Regional and Multi-Lateral Agreements and Conventions including the United Nations Convention on the Law of the Sea (UNCLOS) and the Convention on Biological Diversity (CBD), the InternationalSeabed Authority (ISA) and Global Ocean Spatial Planning and uses and the multitude of South Pacific Region compulsory regulations including Environmental ImpactAssessments (EIAs) and compulsory EnvironmentalRegulations. We cover an extensive rangeof components necessary and compulsory RegionalLegal and Regulatory Frameworks consistentwith Trade Related Intellectual Property Rights (IPRs), Certificateof Origin and WTO regulations for contract formulation to negotiation.
  • 6. SOUTH PACIFIC REGION PRIVATE SECTOR MARINE BIOTECHNOLOGY SCIENTIFIC RESEARCH AND DEVELOPMENT MARINE BIOTECHNOLOGY RESEARCH AND DEVELOPMENT & PRIVATE SECTOR INVESTMENT We are experts in our field and understand the importance of marine biotechnology research and development (R & D). We have local and international specialists and experts, technologies and resources strategically collaborating in a multi- disciplinary and holistic approach to marine biotechnology research and development, as an essentially important part of the bio-discovery process. Based on the multitude of multi-sectoral disciplines associated with scientific marine research, from collection processes, multiple screening and research and development methodologies. These new technologies, have completely transformed scientific research and “new-to-science” discovery processes from 10 – 20 years of research in the laboratory, to a few seconds, with marine biotechnology products commercialised and patented and on the retail shelves within potentially 1 – 2 years. The impact of these innovations in the scientific and biotechnology community has enabled faster, effective, safe and healthy quality marine biotechnology products. The number of patents in marine biotechnology products is increasing, as the ratio of new products or products with novel uses and characteristics. Combined with other biotechnology equipment has become more commercially viable to prospective investors and collaborators, as emerging technologies and efficiencies make product discovery to production and manufacturing effectively and profitable.
  • 7. SOUTH PACIFIC REGION MARINE BIOTECHNOLOGY RESEARCH & DEVELOPMENT We manage and facilitate the discovery of “new-to-science” ingredients sourced from biologically rich and diverse endemic marine ecosystems represents one of the most promising and highly outcomes of marine biotechnology research, development and discovery of “new-to-science” products with a variety of commercial and novel applications including environmental sustainability. This includes collaborative innovations in marine biotechnology development, genomics, molecular and chemical engineering, bioreactor design bioprocess engineering and transgenic production, combined with efficient processing and production applications necessary to meet the needs of both discovery and bulk production of novel marine bio products. Working in partnership with a global connections inventing a new generation of tools and processes that will enable a greater understanding of the ocean and its resources and lead to the discovery of new bio products for the future, and designing methods for their sustainable development, production and manufacturing. Biochemical produced by marine invertebrates, algae and bacteria, are very different than those from related terrestrial organisms and offer greater potential as new classes of medicines. In addition to new medicines, other uses for marine- derived compounds include: Cosmetics (algae, crustacean and sea fan compounds), Nutritional Supplements (algae and fish compounds), artificial bone (corals), and Industrial Applications (fluorescent compounds from jellyfish, novel glues from mussels, and heat resistant Enzymes from deep-sea bacteria).
  • 8. THE SOUTH PACIFIC REGION MARINE BIOTECHNOLOGY INDUSTRY PRIVATE SECTOR INITIATIVES AND COMMERCIAL COLLABORATIONS We make your bio-discovery and research and development process moreefficient and results driven. Using the latest innovative analytical instruments, essentiallaboratory equipment supplies and bio-tools for researchers working in the fields of antibodies, cultures, biology, electrophoresis, genomics, proteomics and others for new-to-sciencemarine biotechnology discovery research and development (R&D) technologies. These technologies fasttrack the efficiency at which new to science gene species can be identified and scientifically characterised for their application and uses and sector of marine biotechnology authenticated for scientific efficacy and applications for commercial development into the “new biotechnology product”. This will accelerate your application with our complete portfolio of analytical technologies and laboratory products spanning research, discovery and production. With a strong focus on scientific research and development enabling scientists and laboratories advancing “new-to-science” bio-discoveries with novel tools to innovate and support their pioneering efforts. R&D strategies navigate every step of the product development process to bring new products to market with more predictability and efficiency and technologies to authenticate their efficacy. With integrated strategies to maximise value adding potential, includes bio-additives applications with other existing products. We minimise risk with up to date, accurate analysis and commercial insights in the development planning and implementation phases. We provide practical strategies from world-class experts
 and work with the new realities compliance with ethical and regulatory standards to global commercialisation as part of our Private Sector Commercial Collaboration. SOUTH PACIFIC MARINE SCIENTIFIC RESEARCH & DEVELOPMENT & COMMERCIALISATION OF
  • 9. MARINE BIOTECHNOLOGY PRODUCTS With successful “new-to-science” marine genetic resources, their microorganisms and the capabilities of the latest innovations in multiple screening of sampling, interpretation of characterisation and potential scientific applications and uses, screen with more in depth and higher probability of success. Utilising biotechnology research and development technologies, for a multitude of scientific purposes in the development of new products, including production and manufacturing technologies and capabilities. We only work with established and innovative outstanding leading Academics, Scientists, Researchers and Biotechnology Product developers. With years of relevant experience in the South Pacific Region and internationally, up to date with the latest industry developments including innovations and advances in technologies used for various applications in Marine Biotechnology Research and Development (R & D), necessary. Coupled with a genuine understanding of the challenges, needs and objectives of our prospective clients, ensures we deliver insightful and strategic solutions in a cost effective commercial and efficient way. The uniqueness of the endemic marine biological environments of the South Pacific Region for marine biotechnology industry is substantial and an economic indicator of the unprecedented commercial potential of the unique marine genetic resources of the South Pacific Region.
  • 10. MARINE BIOTECHNOLOGY INDUSTRY POTENTIAL FROM THE SOUTH PACIFIC Marine biotechnology involves the discovery and application of products and processes derived from marine organisms. Marine biotechnology's promising future reflects the tremendous biodiversity of the world's oceans and seas. The oceans and seas cover more than three-quarters of the earth's surface. Marine organisms accountfor a major share of the Earth's biological resources. Most major groups of living organisms are primarily or exclusively marine. Science has identified close to 200,000 species of marine algae, animal bacteria, fungi and viruses, with perhaps as many as four times this number of organisms as yet unidentified. Tropical marine environments harbour an especially wide diversity of animals and plants. The scientific potential of marine biotechnology is reflected in the multitude of marine organisms’ and their unique qualities based on need to adapt themselves to the extremes of temperature, pressure and darkness that are found in the world's seas. The demands of the marine environment have led these organisms to evolve unique structures, metabolic pathways, reproductive systems, and sensory and defence mechanisms. The potential to generate significant wealth and the equitable and sustainable management of these new revenue streams, capitalising on new employment opportunities and other indirect economic benefits is of critical importance. Opportunities for commercial collaborations, partnerships, consortiums with the South Pacific Region.
  • 11. SOUTH PACIFIC REGION MARINE BIOTECHNLOGY PRODUCTS INDUSTRY COMMERCIAL POTENTIAL & EXPORT DRIVEN GLOBAL MARKET INDICATORS MARINE BIOTECHNOLOGY PRODUCTS IN THE COSMETICS INDUSTRY MARINE BIOTECHNOLOGY PRODUCTS IN THE NUTRACEUTICALS INDUSTRY
  • 12. MARINE BIOTECHNOLOGY PRODUCTS FOOD PROCESSING & PRESERVATION MARINE BIOTECHNOLOGY PHARMACEUTICALS VITAMINS & SUPPLEMENTS GLOBAL CORPORATE STRATEGIC ALLIANCES IN THE MARINE BIOTECHNOLOGY INDUSTRY & GLOBAL SALES
  • 13. AND MARKETS We are the PRIVATE SECTOR with an Strategic Global Commercial expert connections in all fields of Marine Biotechnology from Academics, Scientific Research and Development Experts, Biotech Companies, Marine Biotech Technologies, Innovative Financial Arrangements Options and Innovative Marine Biotechnologists and Corporate Strategic Alliances and high-profile media and marketing connections, to raise the profile and brand power to maximise global sales using our global marine biotechnology products branding and “niche marketing” strategies. Our global established networks and spheres of influence include our networks in 180 countries including focal points:  AUSTRALIA & NEW ZEALAND: Surfers Paradise, Brisbane, Sydney, Melbourne, Australia  SOUTH PACIFIC REGION: Apia, Samoa, Suva, Fiji, Noumea, New Caledonia, Tahiti (all Pacific Island Countries)  ASIA: Hong Kong, Beijing, China, Singapore and selected Asian countries  EUROPE: London, (UK) Dublin, Ireland, Edinburgh and Glasgow Scotland, Amsterdam, Holland, Paris, France, Geneva, Switzerland, Bonn, Germany, Vienna, Austria  USA & CANADA: Ontario, Canada, New York, San Diego, San Francisco, California, Washington, USA  SOUTH AMERICA: Rio de Janeiro, Sao Paolo, Brazil, Uruguay, Chile, Argentina  SCANDANAVIA: Copenhagen, Denmark, Stockholm, Sweden, Oslo, Norway, Finland
  • 14. GLOBAL COMMERCIALISATION FOR DIRECT SALES TO INTERNATIONAL MARKETS GLOBAL COMMERCIALISATION OF “new-to-science” MARINE BIOTECHNOOGY PRODUCTS Consultancy and Management Services integrated into our collaborative Agreements include planning, design and direct sales for “new-to-science” Marine Biotechnology products for Global Commercialisation include:  Branding  Marketing  Advertising Campaigns  ProductLaunches and Trade Shows  Direct Marketing and Sales to international markets  Raising the Profile of each new Marine Biotechnology Productto the global marketplace via a rangeof unique marketing strategies to the widestaudience of consumers possible
  • 15. COMMERCIAL COLLABORATIONS AND CONSORTIUMS WITH THE SOUTH PACIFIC REGION SIGNIFICANT PARTNERS IN MARINE BIOTECHNOLOGY INDUSTRY COMMERCIAL CONTRACTUAL AGREEMENTS We bring together leading academics, scientists and research and development industry, private sector and biotechnology companies and Small to Medium Size (SMEs), Entrepreneurs, leading Biotechnology Companies and Associates from marine biotechnology organizations to encourage the development of commercial marine biotechnology. We develop, prepare, consult positions and advise and negotiate recommendations for commercial contractual collaborations. Facilitate consultations and negotiations in conjunction with expert specialised legal advice to ensure compliance with all regional compulsory requirements, relevant protocols, licences, permits, intellectual property rights (IPRs), patents, Biosecurity and WTO regulations Advise prospective commercial partners in the development and formulate a commercial collaborative contract to negotiate with Significant Partners. We integrate the South Pacific Region’s complex, synergies in Regional and National Legal and Regulatory Frameworks for compliance. We cover an extensive range of compulsory components necessary for contract formulation to negotiation.
  • 16. COMMERCIAL COLLABORATIONS WITH SIGNIFICANT PARTNERS IN THE SOUTH PACIFIC REGION FOR MARINE BIOTECHNOLOGY PRODUCTS AND GLOBAL MARKETS Prospective collaborative partnership initiatives in marine biotechnology commercial research and development activities and projects (and each of its components) have the following details: (variable) an example or guideline: 1. Commercial Feasibility studies and Commercial Strategy Recommendations 2. Projectinformation (Description of proposed commercialactivity, aims, objectives, resources, input/output and legalities) 3. Companies using research on genetic resources (Biotech Company) 4. Research organizations working with companies (R & D Institutions) 5. Parties approving/sponsoring relevant research (Financial Arrangements) 6. Access Benefit sharing terms (Incentives and Investment Strategy) 7. Patents or other forms of Intellectual Property (IPRs) for Licencing (mutual protection) 8. Common and scientific names of the source organism (Certified) 9. Geographical area where the organism was collected (Authenticated)
  • 17. 10.Publications (depending on Private or Public Arrangements and Contractual) 11.Databases (as per Contractual Mutual Agreements for Private Funding and other Agreed Arrangements) 12.Commercialized products (Commercial Marketing and Sales Arrangements With world-class experienced industry experts and specialists, our integrated consulting teams bring you sustainable implementable strategies that integrate a multitude of relevant components in the complex global marine biotechnology industry and consistent with World Intellectual Property Rights (WIPO), Trade Agreements, Regional and Multilateral Environmental Agreements (MEA) s and World Trade Organisation (WTO) standards. 
It is essentially consistent relevant National and Regional South Pacific Region Private Sector and Transnational Businesses and International Governments; Regional Organisations include the following compulsory components: 1. Precautionary Principle 2. Prior Informed Consent 3. Traditional Knowledge (TK) 4. Interpretation 5. Definitions 6. Environmental ImpactAssessments(EIA) 7. Multi-lateral Environmental Agreements (MEA) 8. Regulatory Legal Rules and Frameworks (RLRF) 9. Commercial Partnerships in Areas beyond National Jurisdiction 10.Biotechnology Health and Safety Standards and Biosecurity 11.Certificate of Origin (CO) 12.Access and Benefit Sharing (ABS)
  • 18. 13.Mutually Agreed Terms (MAT) 14.Intellectual Property Rights (IPRs) 15.Material Transfer Agreement(MTA) and IPRs 16.Best Standard Practises (BSP) 17.Intellectual Property Rights (IPRs) and 18.Trade Related Intellectual Property Rights (TRIP)s 19.Patents, Royalties and Revenue Arrangements 20.Licencing and Co-Licencing Collaborative Arrangements 21.Trade Related Intellectual Property Rights (TRIPS) and Patents 22.Biosecurity and Monitoring Mechanisms throughoutthe process 23.Global Insurancefromstartto Completion 24.Legal Mechanisms to ensure Compliance and Bio- security Enforcement Including a range of other relevant components depending on the complexity and variability of the Commercial Agreement. Collaboration in Marine Biotechnology Industry Development Activities are already mapped out and reaffirmed in both the Convention on Biological Diversity (CBD) and the United Nations Convention on the Law of the Sea (UNCLOS), and the United Nations International Seabed Authority (ISA) compared to other geographic biologically diverse parts of the world. In a unique situation that allows the mutually complementary established frameworks for collaboration to be implemented into a series of Actions Plans with mutual economic benefit, and potentially commercially viable enterprise opportunities for all stakeholders
  • 19. Legally binding provisions as referred to in the United Nations Convention on the Law of the Sea (UNCLOS) and the United Nations Convention on Biological Diversity (CBD) With specific reference to the following Articles contained in the United Nations Convention on the Law of the Sea (UNCLOS) and the United Nations International Seabed Authority (ISA) consistent with South Pacific Regional Conventions integrated into the final text of all commercial collaborations includes:  Maps of UNCLOS regions and Legal Status  Limits of the Territorial Seas and Jurisdiction  Ownership and Control  Exclusive Economic Zones (EEZs)  Regime of the Island  Principles Governing the Area  Development of Resources of the Area  Protection and Preservation of the Marine Environment  Global and Regional Cooperation and InternationalTrade and Investment  Technical Resources, Technology Transfer, Training and Capacity Building  Monitoring and Environmental Assessment  Marine Scientific Research within the Consistentwith the South Pacific’s Global Ocean Spatial Planning  Conduct of Scientific Research  Scientific Research Institutions or Equipment in the Marine Area  Development and Transfer of Marine Technology  General Provisions of InternationalCooperation and Collaboration in Marine Biotechnology
  • 20. Consulting on the feasibility of internationally agreed guidelines on environmental regulations, health and safety in marine biotechnology we integrate:  Risk assessment and risk mitigation and management and
the feasibility of guidelines which facilitates national legislation  Clarification of the relationship between the legal framework of Intellectual Property Rights (IPRs) and relevant Conventions referring to partnerships, collaborations in Marine Biotechnology the United Nations Convention on the Law of the Sea (UNCLOS) and the Convention on Biological Diversity (CBD) and the International Sea Bed Authority (ISA) and the Pacific Island Countries and Pacific Island Country Territories with their security from Australia, New Zealand, France and the USA  Further develop, as necessary, the existing safety procedures to promote scientific development and categorization in the areas of risk assessment and risk management (information requirements; databases; procedures for assessing risks and conditions of release; establishment of safety conditions; monitoring and inspections, taking account of ongoing national, regional and international initiatives and avoiding duplication wherever possible  Compile, update and develop compatible safety procedures into a framework of internationally agreed principles as a basis for guidelines to be applied on safety in biotechnology, including consideration of the need for and feasibility of an international agreement, and promote information exchange as a basis for further development, drawing on the work already undertaken by international or other expert bodies
  • 21. COMMERCIAL COLLABORATIONS IN MARINE BIOTECHNOLOGY INDUSTRY We focus on predicting, measuring and managing, minimizing and preventing risk and integrate it into adapting to changing circumstances. We create a fully integrated enterprise commercial models Collaborations and increased sales and profits, Revenue Recognition, Payment of Royalties as a Guidelines and the latest Global Biotechnology Industry Trends and Updates and others including adapting to a globally competitiveness. A Guideline for a Model Commercial-In-Confidence Collaborative Contractual Agreement would integrate, depending on the nature and complexity of the Contract the following “interpretations” and “definitions” integrated to the recommended model structure and strategy of commercial collaborations in Marine Biotechnology Product Development and Commercialisation and Global Sales “Co-Licencing integrated as Co-Licencing Arrangements in all Commercial Collaborations. A Guideline for a Contract and Commercial Global Strategy aims to maximise global sales to achieve maximum profits from a Private Sector Export Driven Commercial Collaboration with multiple benefits. These are both economic and environmentally sustainable and responsible benefits. Our strategies combine and specify the structure of collaborations and commercial mutually agreed distribution of profits depending on preparation, research and development duration and cost itemised, discovery and commercial applications research and development, production processes and methodologies. Innovative technologies for volume production,
  • 22. appropriate labelling for international markets and appropriate export entry regulations and marine biotechnology products market entry. Our strategies integrate the following necessary components and specifications to succeed in a globally competitive environment:  Collaborative Arrangements for Licences & Mutual Agreements on all Patents  IPR&D Assets and Intellectual Property Rights (IPRs) on Patents Agreements  Collaboration Commercial Agreements Specified and Detailed  Relevant Trade Agreements  Revenue Recognition and defined Arrangements for ProfitAccountability  Material Patents  Research and Development  Discovery and Compliance with Regulatory Processes and Authorities  Production and Manufacturing  Packaging, Labelling and compliance with World Regulatory Standards  Commercialisation Strategies for each new marine biotechnology arrangement  Global Branding and Marketing to maximise global sales and profits  Arrangements for Distribution of Royalties and Payments to Participating Parties to the Contractual Agreement and Audited Accountability We utilise a model that integrates the Commercial Cycle, fromBioprospecting, R&D towards bio-discovery of “new to science” marine biotechnology products by taking a holistic approach. Fromscientific marine research, bioprospecting through to biodiscovery and commercial application and uses through to production to global chain-supply distribution models that succeed, without any “fail-fast” issues or risks thatis linear, slow, inflexible, expensiveto one that is fast, adaptive, cost-efficient, innovative. Consortiums areprivate sector financed with commercially driven towards quality,
  • 23. efficiency, effectiveness, efficacy, health and safety measures and results-oriented rand is committed to measured profit sharing structures, based on commercial probability and results with all stakeholders. We ensureRevenue Recognition and Royalty Payments and distribution of benefits to collaborators integrated into each strategy as included in Licencing Specifications on all Licences and Patents consistentwith World Trade Organisation (WTO) and the World Business Organisation and InternationalChamber of Commerce (ICC) recommendations and in commercial consortia in the Marine Biotechnology Patents and Licencing Collaboration Agreements. COLLABORATION WITH SIGNIFICANT PARTNERS AND CO-LICENCING ON PATENTS AND DEVELOPMENT AND PRODUCTION PROCESSES We integrate the following compulsory components in any Commercial Collaboration with regards to the Nature of Collaboration Nature of Collaboration Arrangements and Mutually Agreed Contractual Specifications: 1. Licences 2. Development 3. Commercialization 4. Manufacturing 5. Global Marketing and Advertising 6. Global Product launches and Product Promotion 7. Global Distribution and Supply Chain Logistics
  • 24. These are specifications and details relating to: 1. The identity of the other party in the arrangement 2. The products being developed, as applicable 3. Any amounts paid or received to date under the arrangement (including up-front licensing fees and payments) 4. Under each arrangement, aggregate potential payments to be made or received 5. The existence of royalty provisions, royalty rates (or ranges within defined percentages if tiered) and any sales thresholds related to rates 6. Duration and termination provisions, including payments the registrant may be required to make in the event of termination ND - Not disclosed: 1. Collaboration Arrangements with Significant Partners. 2. Disclosed only the accounting policies used for collaboration arrangements. 3. Collaboration arrangements with two significant partners, Silent Partners, Equity and Private Capital Entities must include a separatesection for Collaboration Arrangements, which were disclosed in many places in MD&A or in notes to the financial statements. Including: 1. Collaboration Arrangements with Significant partner. 2. Disclosed in Aggregate in the Notes to the Financial Statements. 3. Disclosures in the notes to the financial Statements of Total Amounts Received and Paid during the fiscal year.
  • 25. 4. Disclosed for Major Collaboration Partners in Agreements. We integrate the following as part of our commercial strategies for global success:  Companies large and small approaches to innovation aims  R&D moreefficient through initiatives (private, companies and research institutions)  Standards for recording clinical, qualifying testing sites and training  Technology Transfer, Capacity Building for on-site local Trainers in the South Pacific and internationally  Competitive partnerships and Collaborations and Consortia, to conduct predictive modelling assessments and strategies for success The Standard Guideline for any potential Commercial Collaboration with Significant Partners Contractual Compulsory components integrated into facilitating access to Licences referring to Co-Licencing on all Patents and Trade Related Intellectual Property Rights (TRIPS) including Mutually Agreed Benefits Acquired from a Commercial Marine Biotechnology “new-to-science” product Financial Arrangements. These are integrated and specified into Patents and Co-Licencing Commercial Contractual Agreements with Significant Partners and Collaborative Arrangements.
  • 26. LICENCES AND CO-LICENCING IN PATENTS ON COMMERCIAL COLLABORATIONS  Licencing and Co-Licencing Arrangements and Patents mutually agreed obligations and commitments  R&D services and specifications including process, duration, resources expenditure, commercialnew marine biotechnology product  Patents and Co-Licencing Collaboration Agreements  Manufacturing and Supply Chain Agreements  Participation in joint steering and development committees.  Monitor and Audit Amountof productsales by country and accounts receivable outstanding by each country MATERIAL PATENTS CONTRACTUAL CO-LICENCING ON PATENTS AGREEMENTS & OBLIGATIONS Arrangements regarding material patents and relevant collaborative arrangements including Licencing mutually agreed obligations and Licencing Specified commercial collaboration Contractual Arrangements.  Specifications of Arrangements and mutual obligations for the products or technologies that relate to the Patent  Areas beyond National Jurisdiction in which the Patent is sourced “Certificate of Origin” acquired and granted and Co-Licencing Commercial Arrangements referring to Patents and Certificate of Origin
  • 27.  Expiration date, identification of patents subjectto legal proceedings and Patent obligations including co-licencing arrangements specified in relevant documentation We IntegrateAdditional Information explaining ways the IPR&D Assets were:  Verified “in-situ “with “Certificate of Origin” and Patent, Intellectual Property Rights (IPRs) Licencing and Co- Licencing on Patents Mutual Agreements on an individual basis  Agreements regarding the control over the amountof information disclosed  No. Of IPR&D assets, or a limited number of IPR&D assets recorded In order to gain a better understanding of the effects and expected effects of your research and development activities on results of operations and financial position the following additional information for significant products in research and development is provided:  Specified and Itemised duration and costs incurred during each period presented.  Maintaining any research and development costs with quantitative or qualitative disclosurethatindicates the amount of the company’s resources being used on the project.  Nature of efforts and steps necessary to complete the product.  Risks and uncertainties associated with completing development, extent and nature of additional resources that need to be obtained if currentliquidity is not expected to be sufficient to complete the product. Revenue Recognition Requirements:  Nature of each revenue deduction, along with information about the key terms of material arrangements or agreements that influence the estimate of each deduction as of each balance sheet date
  • 28.  Levels of inventory in distribution channels  Estimated remaining productshelf lives  Shipments of productmade as a result of incentives or in excess of the customer’s ordinary demand  Quantitative information related to qualitative factors a registrant considers when it estimates each revenue deduction  The underlying business reasons for materialperiod-to-period fluctuations for each type of reduction of gross revenue, including the effect that changes in estimates have on revenues and obligations FINANCIAL ARRANGEMENTS FOR COMMERCIAL COLLABORATIONS AND GLOBAL CORPORTATE STRATEGIC MONITORING MECHANISMS AND COMPLIANCE We integrate Financial Management Strategies for Execution and Implementation of Global Revenue Recognition Mechanisms, facilitating execution of Royalties and mutually Agreed Financial Structures and Distribution among Stakeholders or Collaboration Arrangement Disclosures and Payments  Financial Arrangements and strategies regarding private and public disclosures related to collaboration arrangements.  Specified list of items subjectto disclosureamong Collaborating Consortia  Identification of the “
other parties” in the “Commercial-In-ConfidenceContractualArrangement”  Products being developed in Marine Biotechnology Industry and their potential applications and use  Amounts paid or received under the arrangements  Aggregate payments to be paid for each biodiscovery of “new-to-science” marinegenetic resources and Patent Arrangements  Provisions of royalty paymentrates and global market sales by sector, country and volumeof production and sales
  • 29.  Annual maintenance fees, including duration and termination provisions and payments the registrantmay be required to make in the event of termination.  Payment obligations under collaboration arrangements mustalso list any potential payments in the contractual obligations and mechanisms for compliance RESEARCH AND DEVELOPMENT (R & D) EXPENSES FOR EACH “new to science” MARINE BIOTECHNOLOGY PRODUCTS DEVELOPED The Marine Biotechnology Industry incurs significantexpenses for R&D activities to develop a limited number of new marine biotechnology products in relation to the number of compounds developed.  R & D spending of by project segment, stage of development itemised within the context of the total strategy commercial process  Approvals by international Governments for marketentry into predominantly Asia, Europe, UK and USA  The time it took compared to estimates to complete clinical tests and compulsory regulatory approvals  The Impactof R & D Projects and the company’s futureoperations and/or liquidations  Audited Research & Development Expenses specifications  Research and Development Resources and Equipment Expenses and Logistical Arrangements and Structures  Monitoring, evaluation agreed strategies and mechanisms and Biosecurity Arrangements  Related Costs incurred to date compared with estimated expenses including insuranceand monitoring mechanisms  Estimated Completion Dates and final completion dates referring to commercially viable new marine biotechnology products  Completion Costs and Capital Requirements and estimated start and completion specified in Licencing Arrangement  The Extent to which a Project’s Success is Assessed Depending on parties other than the registrant  Discussion of the project’s phases and a description of the natureof the products in the pipeline
  • 30.  Providequantitative or qualitative disclosures thatdescribe the amount of resources being used on each project or group of projects COMMERCIAL COLLABORATIONS REVENUE RECOGNITION AND ROYALTIES PAYMENTS AUDITED & ACCOUNTABILITY PROCEDURES  Revenue as they relate to obligations based on Contractual Co-Licencing mutual agreements  Revenues and Royalties when recognizing revenue for the sale of a new, novel or unique products MARINE BIOTECHNOLOGY INDUSTRY REGULATIONS AND COMPLIANCE WITH REGULATORY AUTHORITIES, TRADE AGREEMENTS, WTO AND SUPPLY-CHAIN LOGIGISTICS FOR GLOBAL SALES AND MARKETING & DISTRIBUTION Providethe following information aboutacquired Licencing and Patents Arrangements for Intellectual Property Rights and Research and Development Processes for biodiscovery, scientific Research and Development, Specialised Marine Biotechnologist and other necessities depending on the complexity and duration InnovativeMethodology Commercial Applications Development and Productprocesses for production and manufacturing, packaging, labelling, authenticity, compliance with regulatory authorities for each sector in export market destination with specifications regarding labelling and coding, monitoring, global chain-supply logistics for distribution to global markets.
  • 31. Commercialisation Processes and formalities for integrated collaboration on Global Branding and Global Marketing Strategies to Maximise sales to consumer markets. Global Branding and Marketing materials, advertising, multi-media, globalbusiness strategic networks for a productis new, novel or unique in some aspect integrating into the Global “niche-marketing strategy” depending on the marine biotechnology “new to science” product. Recent press releases and productlaunches and integration into Global Strategic Trade Shows and Exhibitions in the Marine Biotechnology and Associated Industries  Latest global consumer market trends, sales and demand in the specific marine biotechnology products  Determine whether selling prices arefixed or determinable in order to recognizerevenue upon  Delivery of products to customers and cost-effectivechain supply delivery to global markets  Financial Statements audited and monitored  Marine Biotechnology ProductPerformance:  Profitearnings specifications by country, volumeand net sales  Description of earnings fromglobal sales  Breakdown of calculation of income  Audited Explanation of the purposeof the earnings figure  Audited Explanation for significant earnings highlighted
  • 32. Risk Management and Mitigation: Descriptions of Key Risks of Industry specific risks integrated includes  Intensecompetition around branded products  Costly and highly uncertain natureof research and development  Competition fromlower-priced generic products  Loss or expiration of intellectual property in the near future  Unexpected developments related to safety or efficiency of product  Pipeline productivity and competition — ability to continuously develop or replace products  Pricing and access pressures  Currentand future product liability claims  Potential exposureto government price controls  Ability to obtain and maintain approvalfor products  Potential noncompliance issues and scrutiny fromTGA, FDA and other regulators  Adverseeffect fromchanges in laws and regulations  High dependency of revenues, cash flows and earnings on protections given by Patents General Risks:  Manufacturing and supply-chain difficulties  Reliance on third-party and outsourcing arrangements  Financial distress and bankruptcies experienced by significant customers
  • 33.  Economic factors, including inflation and fluctuating interest rates and currency values  Interruptions of computer systems, impairing ability to conduct business  Vulnerability of key company products, and their significant profits and cash flows, to adverse market events  Failure to realize the anticipated benefits of strategic initiatives and acquisitions