Project Implementation Guidelines (PIG)

Project Implementation Guidelines (PIG) V2 Second Phase of the Finnish Southern African Partnership Programme (BioFISA II) to Strengthen NEPAD/SANBio Network NEPAD Ministry for Foreign Affairs of Finland, Department of Science and Technology of the Republic of South Africa September 2017

Table of Contents Table of Contents... ii Key contact information for BioFISA II Programme Unit and SANBio Network... iii List of Annexes... iv Glossary of Terms... v List of Abbreviations... ix BioFISA II Project Management in a Nutshell... x Project Implementation Guidelines overview... xi Review and distribution of Project Implementation Guidelines... xi 1. Introduction... 1 2. Project Governance... 1 2.1 Management structure of project consortia... 1 2.2 Lead Partner s Responsibilities... 1 2.3 Project management committee... 2 3. Project management... 3 3.1 Rationale for effective project management... 3 3.1.1 Risk Management... 3 3.1.2 Quality Management... 3 3.1.3 Configuration Management... 3 3.1.4 Communication Management... 4 3.2 Key team members in project execution and management... 4 4. Management of Intellectual Property... 5 4.1 Recommendations for projects to deal with Intellectual Property in Seed and Flagship Projects... 5 5. Financial Management... 6 5.1 Costs supported by the SANBio/BioFISA II Grant... 6 5.2 Project disbursement procedures... 7 5.3 Project funding disbursed to Co-Partners... 8 5.4 Record keeping, monitoring and control for project finances... 8 5.5 Consequences for under-reporting, misuse and abuse of funds... 10 6. Project Reporting... 11 6.1 Frequency of reporting and reporting timelines... 11 6.2 Monthly Highlight Report... 11 6.3 Milestone report (End Stage Report)... 11 6.3.1 Audit Report... 12 6.4 Completion Reporting (End of project report)... 13 7. Procurement... 13 7.1 Procurement guidelines... 13 7.2 Procurement framework... 14 7.3 Contract negotiations and management... 14 8. Monitoring, Evaluation and Learning... 15 8.1 Overview of Programme monitoring and measuring for results... 15 8.2 Project and Programme Evaluation... 17 8.3 Incorporating MEL into Programme and Project learning and best practice... 17 9. Ethical guidelines to be followed for SANBio/BioFISA II Projects... 17 ii

Key contact information for BioFISA II Programme Unit and SANBio Network Physical address: BioFISA II Programme Unit CSIR Biosciences, Building 20, CSIR Meiring Naude Road Brummeria, Pretoria, South Africa 0184 Postal address: BioFISA II Programme Unit C/O CSIR Biosciences P O Box 395 PRETORIA 0001 Contact person Designation Email Office Phone Dr Ereck Chakauya Ms Zvikomborero Tangawamira Ms Marja-Reetta Paaso Mr Markku-Eemeli Pekonen Ms Thiru Naidoo- Swettenham Mrs Nontobeko Zulu Ms Nokwanda Ncube SANBio Network Manager BioFISA II Programme Manager BioFISA Chief Technical Advisor BioFISA II Programme Officer BioFISA II Office Administrator/Manager SANBio Network Secretary BioFISA II Finance Intern EChakauya@csir.co.za 0027 12 841 3837 ZTangawamira@csir.co.za 0027 12 842 7334 MPaaso@csir.co.za 0027 12 842 7998 MPekonen@csir.co.za 0027 12 841 4039 TNaidooswettenham@csir.co.za 0027 12 842 7998 NZulu@csir.co.za 0027 12 841 3808 NNcube1@csir.co.za 0027 12 842 7998 iii

List of Annexes Annex 1: Project Contract Template/ Grant agreement Annex 2: Memorandum of Agreement to form a Consortium Annex 3: Non-Disclosure Agreement Annex 4: Financial Administration Templates for Project Teams Annex 5: Invoice Template for Projects Annex 6: Disbursement request template Annex 7: BioFISA II Programme Results Framework Annex 8: Project Asset Register Annex 9: List of Reports Annex 10: Project Audit report guidelines Annex 11: Communications guidelines for projects Annex 12: MEL Project Reference Sheet Annex 13: Project Management and IP Annex 14: Technology Readiness Levels Annex 15: Risk register iv

Glossary of Terms Assignment of IP: Involves the selling of IP or ceding of ownership of IP to a party for a significant once off payment. There are no further obligations or further compensation from the recipient to the original IP creator/ or IP holder. Background IP: refers to IP which may be relevant to a particular project, held by a party when the project begins or developed outside of the scope of the project. BioFISA Programme: The Finnish-Southern African Partnership Programme to strengthen the Southern African Network for Biosciences. The BioFISA Programme focuses on building a function and sustainable biosciences network for collaborative research and on capacity building through training including entrepreneurial skills. BioFISA II Programme Unit (BPU): The team who are tasked with management, implementation, coordination, monitoring and reporting of the BioFISA II Programme. The team consists of the Chief Technical Advisor, Programme Manager, Programme Officer, Office Administrator/Manager and the Programme Administration Intern. Project partners liaise with and report directly to the BPU. The BPU is responsible for overall monitoring of the projects funded by SANBio/BioFISA II, and in linking the project level monitoring with the programme level monitoring. The BPU works with the SANBio Secretariat and reports to the BioFISA II Steering committee. BioFISA II Steering Committee: The Steering Committee for BioFISA II has representatives from New Partnership for Africa s Development, Ministry for Foreign Affairs, Finland, and Department of Science and Technology, South Africa. The SANBio Network Manager is also a member of the SC. The BPU attends the SC but has no voting rights or decision making authority. Co-Partner/s (CP): are part of the project consortium and report to the Lead Partner, but have joint accountability and responsibility for delivering project results Commercialisation: Commercialisation is the process by which a new product or service is introduced into the general market. Commercialisation is broken into phases, from the initial introduction of the product through its mass production and adoption. It takes into account the production, distribution, marketing, sales and customer support required to achieve commercial success. As a strategy, commercialisation requires that a business develop a marketing plan, determine how the product will be supplied to the market and anticipate barriers to success. Council for Scientific and Industrial Research (CSIR): CSIR provides operational and management support to SANBio through the Biosciences Unit. The CSIR is the contracting partner for all BioFISA II funded projects. The CSIR hosts the SANBio Secretariat and is the regional SANBio Hub. CSIR provides in kind support to host the SANBio Secretariat. CSIR is responsible for disbursement of project funds. Donors: refer the both financiers of BioFISA II: the Ministry for Foreign Affairs of Finland (MFA) and the Department of Science and Technology of the Republic of South Africa (DST) and the Member States that contribute to the Programme through projects implemented in their countries. Foreground IP: refers to intellectual property developed during the course of a project. Innovation: Innovation is the creation of new value and/or capturing value in a new way. The actions required to create new ideas, products and processes which when implemented lead to positive effective change. While invention requires creation of new ideas, processes and products, innovation involves one step further and requires implementation of the inventive act. Intellectual Property Rights (IPRs): Refer to the protection afforded by the law to various forms of IP. IPRs are designed to stimulate innovative and creative activity, to encourage the dissemination of the outcomes of such activity and to promote economic and social development. Innovators and creators are typically rewarded with the exclusionary time limited rights to control how their IP is used, and by whom, allowing them to recoup the investment they made in the development of the IP concerned. When these rights expire the IP enters into the public domain, allowing anyone to use it in the development of new knowledge and IP. Invention: An invention can be defined as the conception or development of a product that is new or useful. A research outcome can be constituted as an invention if it meets some or all of the following criteria: it can be v

described as new, novel or unique; it is unusual or unexpected; it solves a significant problem; it is useful and meets a need; and it has commercial application and commercial value. Lead Partner (LP) is the main responsible party of the consortium (of companies/organizations/institutions) which has submitted a successful project proposal and been selected for funding by SANBio/BioFISA II, and is the main contracting partner who has signed the contract agreement for the BioFISA II funded project with the CSIR. LP reports to the BioFISA II Programme Unit on behalf of the consortium and has overall accountability and responsibility for project implementation, monitoring and control and delivering project results. License: A license is an agreement in terms of which an IP holder allows a third party to use that right, usually in return for some form of compensation. Licensed technologies must be properly defined in terms of relevant patents/patent applications/know-how and tangible property. Material transfer agreements: This agreement governs the transfer of biological material between parties and states who may use the material, the purpose and uses of the material and who owns the IP (including modifications to basic biological material). Memorandum of Agreement: This agreement records the underlying understanding between contracting parties in a binding document. It is a legally enforceable contract conferring rights and obligations to the contracting parties. Memorandum of Agreement to form a Consortium: Collaboration between two or more parties on an agreed project or programme. The agreement includes the roles and responsibilities of each partner, funding, governance and decision making, IP ownership, management and benefit sharing. Non-disclosure agreements (NDAs): Also referred to as secrecy or confidentiality agreements are used to facilitate discussions with potential collaborators, investors and licensees and may involve unilateral or mutual exchange of information. Each party undertakes to maintain the confidentiality of information received and to use it for a specified purpose. Patent: Refers to IP such as inventions, including products, processes, compounds and devices, and are protected for 20 years from the date of filing. Plant breeder s rights: Refer to IP that is afforded to new plant varieties which have been created through breeding and genetic modification. Trees and vines are protected from 25 years from date of registration and all other eligible plants are protected for 20 years from date of registration. Project consortium: The project consortium comprises the main implementing partners of the project or grant recipients consisting of the organisations representing the Lead Partner and Co-Partners. Project Manager: Named by the Lead Partner, is responsible for project administration of the funds received and collation of reports etc. for submission to the BPU. Project (implementing) team: This refers to the officers appointed by the organisations in the project consortium to carry out the day to day activities for the project. Each project team has at least the following core team members: Senior Scientist, Project Administrator/Coordinator and Business Expert. The project implementing team may consist of additional members from the Co-Partner and Lead Partner depending the needs and scale of the project and project timeline. Project management committee: The main purpose of the project management committee is to ensure that there is accountability for project activities and project expenditure, ensure that adequate monitoring of the project and ensure that the team meets its goals, and undertakes steps to address any shortcomings in project progress and ensures that timeous and accurate progress reporting is made to BPU. The project management committee may also be tasked with developing new partnerships and engagements to take the project further for example sourcing new funding partners or commercialisation partners. Proof of concept: is also referred to as proof of principle and is a realization of a certain method or idea to demonstrate its feasibility, or a demonstration in principle, whose purpose is to verify that some concept or theory has the potential of being used. A proof of concept is usually small and may or may not be complete.. vi

Prototype: An early sample, model, or release of a product built to test a concept or process or to act as a thing to be replicated or learned from. It is a term used in a variety of contexts, including semantics, design, electronics, and software programming. Registered rights: Refer to industrial designs and features of appearance. Aesthetic designs have protection for 15 years from date of filing or release date and functional designs have protection of 10 years from date of filing or release date. Southern Africa Network for Biosciences (SANBio): SANBio provides a shared research, development and innovation platform for working collaboratively to address some of Southern Africa s key biosciences issues in health, nutrition and health-related intervention areas such as agriculture and environment. SANBio was established in 2005 under the New Partnership for Africa s Development (NEPAD), as one of five networks established under the African Biosciences Initiative (ABI) to cover the SADC region. The Network is operated on a regional hub and nodes model, with the Hub at CSIR Biosciences and the six nodes in Malawi (1), Mauritius (1), Namibia (1), South Africa (1) and Zambia (2). Network operations are facilitated by the SANBio Hub which hosts the Secretariat on behalf of all the stakeholders. SANBio Secretariat: The SANBio Secretariat is hosted by the SANBio Hub at CSIR Biosciences. SANBio Secretariat is headed by a Network Manager and is responsible for the effective and efficient management of the Network, the delivery of its programmes and raising sufficient resources to achieve SANBio s Vision and, in conjunction with the SANBio Steering Committee, provides a mechanism for independent review of Network proposals and progress. SANBio Nodes: Institutions selected by SANBio that focus on six thematic areas prioritised by SANBio. The Nodes were selected through an open competitive process. SANBio Member States: The SANBio Member States refer to the 12 SADC countries that are eligible to participate in the SANBio Programme. The organisations in these countries including inter alia, research institutes, academic organisations, private companies, small medium and micro enterprises and nongovernmental organisations are eligible to access funding from SANBio and BioFISA II Programme for their capacity building, networking and dissemination activities. The current SANBio Member States are Angola, Botswana, Madagascar, Malawi, Mauritius, Mozambique, Namibia, Lesotho, South Africa, Seychelles, Swaziland, Zambia, and Zimbabwe. Sub-contracts: An agreement that is in use where a principal contractor needs the services of another party in the delivery of a principal agreement or project deliverable. The agreement includes the scope of service and work to be performed, the management of IP and the payment for the service. Team Leader: is responsible for overall management of the project including management of deliverables and milestones from Co-Partners and can be represented by anyone in the team from the consortium, preferably from the Lead Partner. Technology demonstrator: is an example or an otherwise incomplete version of a conceivable product or future system, put together as proof of concept with the primary purpose of showcasing the possible applications, feasibility, performance and method of an idea for a new technology. They can be used as demonstrations to the investors, partners, and potential customers in order to convince them of the viability of the chosen approach, or to test them on users to assess the viability and versatility of a product or service. Technology transfer: is the process of transferring new knowledge and technology developed at a research institution or university to third parties who can realise value from them by making them available to the market and society, commercially and for social good. Technology readiness levels: Technology readiness levels are a method of estimating technology maturity ranging from TR 1 (basic principles observed) to TR 9 (actual system proven in operational environment). Tender: Tender is defined as a written offer in prescribed or stipulated form in response to an invitation for provision of services, works or goods through price quotations, advertised competitive tendering process or proposal. vii

Trademarks: Refer to words, phrases, symbol, logos and colours that distinguish goods and services used to distinguish a product or a commercial entity. Trade marks have validity for 10 years from date of filing, and are renewable indefinitely at 10 year intervals. Trade secrets: refers to confidential information and know-how which is kept secret. This is knowledge residing within an institution or a team and the type of protection afforded is indefinite. viii

List of Abbreviations ABI ARIPO AU AWP BE BioFISA BPU CfP CSIR CTA DST EoI ID IP IPR ISO LP MDS MEL MFA NDA NEPAD PA PIG PM QA R&D RBM RFP RFQ SADC SANBio SC SS STI TA ToR VAT ZAR African Biosciences Initiative African Regional Intellectual Property Organization African Union Annual Work Plan Business Expert for the project Finnish - Southern African Partnership Programme to strengthen the Southern African Network for Biosciences BioFISA II Programme Unit Call for Proposal Council for Scientific & Industrial Research BioFISA II Chief Technical Advisor The Department of Science and Technology of the Republic of South Africa Expression of Interest Identity document Intellectual Property Intellectual Property Rights International Organisation for Standardisation Lead Partner Milestone and Disbursement Schedule Monitoring, Evaluation & Learning Ministry for Foreign Affairs of Finland Non-Disclosure Agreement The New Partnership for Africa s Development Project Administrator/Coordinator Project Implementation Guidelines BioFISA II Programme Manager Quality Assurance Research and Development Results-based Management Request for Proposal Request for Quote Southern African Development Community Southern Africa Network for Biosciences Steering Committee Senior Scientist for the project Science, Technology and Innovation Technical Assistance Terms of Reference Value-added tax South African Rand ix

BioFISA II Project Management in a Nutshell The following steps are recommended for effective project management of the projects awarded Seed and Flagship Grants Activity Frequency / Timeline Team responsibility Document output/ Project control Work plan preparation and work plan review Set-up a project management committee and select At the start of the project All team members Work plan a Team Leader Work plan preparation and finalisation Project budget Defining project milestones and deliverables Work plan progress review Financial administration Human resource administration of key personnel on project team and other personnel Managing resources paid for additional specialist and technical services Audited financials Ongoing monitoring of projects progress report preparation based on progress towards milestones and deliverables Developing a sustainability plan or exit strategy for project team At proposal submission stage, during first month of project, incorporate any recommendations from evaluators and make any recommended changes from the BPU Submitted at proposal submission stage, may be revised at time of contract to incorporate any recommendations from evaluators and BPU At proposal stage, and may be revised before contracting Every six months as defined by the BPU, submit significant changes for BPU to approve x Project team Project team Project team Team Leader and project management committee Financial administration and resource management Monthly recording of financial Project transactions on project using Administrator/Coordinat templates provided or and Team Leader in Detailed expenditure reports from Lead Partner, and organisations financial system responsible team Monthly recording of timesheets on project using templates provided Monthly recording of expenses related to specialist services When 75% of the project milestones have been achieved, corresponding to 75% of the utilisation of resources member in Co-Partner All project team members in Lead and Co-Partners, Project Administrator/Coordinat or and Team Leader Project Administrator/Coordinat or, Team Leader Team Leader and project management committee Project monitoring, reporting, milestone progress and disbursement Progress reports to be prepared in Team Leader and order to communicate project project management progress and correlate with requests committee for disbursement In the last six months of project duration, explore options for new partners, and refine the exit strategy for the consortium Completion report At the end of the project (after 18 months for Seed and 24 months for Flagship projects) Project team, Business expert and technical advisor or investment / technology transfer specialist Team Leader and project management committee Work plan and milestone schedule Project budget Work plan and milestone schedule Updated work plan, approved amendments from BPU if significant changes necessary Monthly financial records for projects as input into end stage financial report Monthly verified timesheets as input into financial report Monthly verified timesheets, verified invoices from service providers Audited financial report Progress report with narrative, financial and results Sustainability plan or Exit strategy Completion report

Project Implementation Guidelines overview The Project Implementation Guidelines is arranged as follows: Section 1: Introduction to the Project Implementation Guidelines. Section 2: Project governance. This section outlines the project governance structures, the role of the Lead and Co-Partners, recommendations for project steering committee and the level of accountability and responsibility for project implementation by the consortium partners. Section 3: Project management: This section details project management and provides information on how the projects should run at a strategic level, and how the project should be implemented for the duration of the grant. Section 4: Management of Intellectual Property. This section provides guidance on the commercialisation and technology transfer process and insight into how intellectual property created in the project should be shared by the consortium. Section 5: Financial management. This section details the financial procedures to be implemented in the programme, detailing eligible and ineligible expenses and the financial disbursement procedures to be followed by the Lead Partner and the Co-Partners. Section 6: Project Reporting: The requirements for project reporting are outlined in this section and include narrative and financial reports, and annual reports. The completion report requirements including the audit report are also included in this section. Section 7: Procurement. This section provides guidance on the recommended procurement policies to be followed for procurement of goods and services and fixed assets for the programme. Section 8: Monitoring, Evaluation & Learning (MEL). The MEL section provides the context for the results framework for the BioFISA II programme and guidance to the projects in terms of selection of indicators for projects. Section 9: Ethical guidelines to be followed for SANBio/BioFISA II Projects. This section outlines some of the requirements projects should adhere to during the execution of projects especially in relation to ethical practice. Review and distribution of Project Implementation Guidelines These guidelines are to be used in alignment with the project contracts and final project proposals which form part of the main contract between CSIR (as the contracting authority on behalf of SANBio/BioFISA II) and the Lead Partner. In instances, where contents of the PIG are in conflict with the project contract, the contract shall be considered as the priority document. In addition, in case of any uncertainty regarding the contents of this PIG, clarifications and further guidance will be given by the SANBio/BioFISA II Programme Unit (BPU) upon request either via e-mail (biofisa@nepadsanbio.org) or through the SANBio website (www.nepadsanbio.org). The PIG is updated and additional guidance added when considered necessary and therefore project teams need to make sure that they are always following the latest version of the document. All project teams will be informed of possible revisions of the PIG through email by the BPU. In addition, the latest version of the PIG will always be available on the SANBio website (https://nepadsanbio.org/press-room-media/document-library). xi

1. Introduction The Finnish-Southern Africa Partnership Programme (BioFISA Programme) is aimed at strengthening regional collaboration in biosciences research and innovation, with a purpose of supporting the implementation of the Southern African Network for Biosciences (SANBio) Business Plan 2013-2018. Since the inception of the BioFISA Programme in 2009, the Programme has been implemented as a support mechanism to the SANBio Network. Much of the funding support has been from the Ministry for Foreign Affairs of Finland (MFA) and the government of South Africa through the Department of Science and Technology (DST). Member States are also expected to contribute to the Programme by co-funding/supporting projects implemented in their countries. The BioFISA II Programme is the second phase of a Finnish-Southern African Partnership meant to strengthen the NEPAD-SANBio Network. BioFISA II commenced in April 2015 and will be implemented until February 2019. Funding under BioFISA II is aimed to support and strengthen biosciences research and development as well as human capacity development in the Southern African Development Community (SADC) region through the existing NEPAD-SANBio network and this documents will assist project teams in understanding what and how they should report on progress under the Seed and Flagship grant mechanism (Seed Grants of up to R1 million and Flagship Grants of up to R4.5 million). The Project Implementation Guidelines (PIG) is to be used by Project Implementing teams/ grant recipients of the Seed and Flagship Projects funded by The Finnish Southern African Partnership Programme to Strengthen NEPAD/SANBio Network (BioFISA II) and its partners. The PIG is to be used as a reference for implementation by project teams and institutions hosting the BioFISA II funded Seed and Flagship projects. In addition to the appointed members of the multipartner projects directly involved in project execution, the PIG is also to be utilised by administration staff responsible for finance, administration and communication in their respective organisations and support those individuals carrying out activities for the projects. The PIG was developed by the BioFISA II Programme Unit (BPU) to assist teams in implementing projects with specific reference to project management, financial management, monitoring and evaluation, reporting requirements, audit requirements, guidance on managing of intellectual property and the ethics requirements for projects. 2. Project Governance 2.1 Management structure of project consortia Each project consortium comprises a Lead Partner (LP) and one or more Co-Partner(s). 2.2 Lead Partner s Responsibilities Lead Partner (LP) is responsible for implementing the project as agreed in the contract made with the CSIR. In more detail this responsibility towards SANBio/BioFISA II and co-funding partners covers the following: Acting as the main contact point from the consortium and ensuring that all relevant information is promptly provided to SANBio /BioFISA II; 1

Reporting the project progress to SANBio /BioFISA II according to the Milestone and Disbursement Schedule (MDS) attached to the project contract, or to an addendum if the contract has been exceeded; Submission of an updated MDS to SANBio/BioFISA II if there are changes in implementation that also affect the reporting. The work plan and MDS should always be prepared considering the realistic timing when the milestones are met; Submission of financial disbursement requests on behalf of the consortium; Receiving funds from the CSIR and disbursing them according to the approved project plan to the Co-Partners; Collection of progress and financial reports from Co-Partners and compiling them into one financial report to be submitted to the BPU; Provides adequate project oversight and management to ensure that Co-Partners are familiar with the SANBio/BioFISA II PIG and procedures to be followed for project implementation; Is responsible for project monitoring and ensuring that the project is delivered on time, on budget and as per agreed deliverables in the proposal; Keeping proper archive records of all project matters including procurement, asset registering and financial documentation including original receipts. 2.3 Project management committee It is recommended the project establishes a management committee which is responsible for overall project governance and oversight in the consortium as per the PRINCE 2 guidelines. The main purpose of the project management committee is to ensure that there is accountability for project activities and project expenditure, ensure that adequate monitoring of the project is done and ensure that the team meets its milestones, and undertakes steps to address any shortcomings in project progress. The project management committee should consist of at least the Executive (who owns the project and has the overall responsibility for its implementation) and the Senior Supplier who represents the interests of those designing, developing, facilitating, procuring and implementing the project s products. They are responsible for the quality of the products delivered by the supplier as well as the technical integrity of the project. The senior user who is responsible for specifying the needs of those who will use the products and should monitor that those needs are met in the products being developed. The general responsibilities of the management committee during implementation include: Approve the stage tolerance level changes; Ensure that timeous and accurate progress reporting is made to BPU; Changes affecting the project delivery schedules and outputs must be agreed by the project committee before submission for approval to the BPU; Communicate with stakeholders as defined in the project communication strategy; Provide overall guidance and direction to the project, ensuring it remains viable and within any specified constraints; Ensure that risks are being tracked and managed as effectively as possible; Approve and endorse all procurement; Approve completed products. At the end of the project implementation, the committee should: Provide assurance that all products have been delivered and acceptance criteria have been met; Authorise project closure and approve project closure reports and deliverables; 2

Authorise follow-on action recommendations and Lessons Reports to be distributed to stakeholders. Decisions taken by the project management committee are binding and the committee should ensure that equal participation in project activities is achieved by all the consortium members, including shared responsibility and accountability for delivery of the project outputs amongst the consortium members. It is recommended that the project management committee be formed within the first month of the project approval. Project management committee meetings should be minuted and held at least every three months. Records of these minutes must be submitted to the BPU as part of the progress reporting. It is not necessary to have face to face meetings every quarter, but it is advised that the project partners should meet at least twice face to face during the project implementation period. The hosting of meetings for them to share project progress has to be in line with travel and accommodation guidelines proposed by the BPU refer to section 5.4. 3. Project management 3.1 Rationale for effective project management All projects funded by the BioFISA II Programme and its partners should be managed following the PRINCE 2 Methodology with a clear risk, quality, configuration and communication management strategy. The Programme is result oriented and therefore the achievement of a Milestone is linked to the results attained in the project. At each stage/milestone, funds disbursed should be managed as defined in the guidelines provided at application stage and in section 5, with respect to eligible and illegible costs. All deliverables must be met for each stage/milestone before disbursements are made for implementing the next project stage. 3.1.1 Risk Management Risks should be measured as High, Medium or Low based on the impact and likelihood of occurrence. The projects need to ensure that the risks identified during the proposal writing stage are well managed and mitigation measures in place are actively implemented and a risk register (attached) should be kept up to date at all times. 3.1.2 Quality Management The project teams should ensure that all documents and deliverables presented to the BPU are of high quality and as defined in the quality management strategy. Reporting templates for each end stage are provided as an annex to this report and these should always be signed off by the project management committee to ensure the quality of deliverables presented to the SC. This in essence is defined by the quality standards used in developing products, i.e. any ISO standards that should be followed, regulatory standards and procedures etc. Records should be kept together with clear responsibilities of the person(s) who ensure the quality that the quality standards are met. 3.1.3 Configuration Management All documents on the project including the reports submitted to the BPU must be stored on the shared Dropbox folder. The documents must be filed with the following filing sequence: date (DDMMYYYY), file name, and version number. The first page of each document produced must have a page that shows the changes made, who made then, when they were made (date) and the latest version number. With each version change, the file documents names must also be updated, mainly on the date and version number to reflect the periods when the document was modified. 3

3.1.4 Communication Management Projects are required to communicate their progress to the BPU in monthly highlight reports and highlight meetings which are held on a monthly basis. These reports should contain information on what was achieved in the last month, what are the deviations and what is planned in the following month. Lessons must be logged in these highlight reports and an indication of the budget status given. Once the projects have completed a milestone in line with their approved plan, an end stage report must be submitted, see section 8 on the list of documents that must be submitted as part of the end stage report. Projects are also required to produce and end of project report once all the deliverables are completed and approved. On various occasions, project teams should report to other stakeholders and market their projects as widely as possible. When doing so, the projects must indicate the sponsorship for project implementation is from SANBio BioFISA II Programme and only the logos provided to the projects for this purpose must be used. These stakeholder engagements must be reported to the BioFISA II Programme in the highlight and end stage reports. Additional details on the tools to use for communicating are provided as Annex 11. 3.2 Key team members in project execution and management Each project team must have the following team members: The Lead Innovator (Project Executive) A Project Manager A Business Expert For each project, the three team members fulfilling these roles must be clearly defined and the names and CVs provided to the BPU at project inception. Each team member must have a clearly defined role and should any team member be replaced, the Programme requires that the role is fulfilled by someone with the same qualification and experience as the person being replaced. The project manager is responsible for reporting and liaison with the BPU and the project management committee. The business expert is responsible for developing and executing the business model defined for the commercialisation of the proposed services or product. The role of the lead innovator will vary depending on the type of invention/whether or not the team executing the project invented the products or not etc. However, for each project, this role must be made very clear as the lead innovator is ultimately responsible for the successful execution of the project. Projects can have larger teams, however within the team defined, these three roles should be included and defined. Signed timesheets for personnel on the project for the specific period must also accompany the financial reports. Annex 4 has a format for the timesheet to be completed by project team members. Timesheets have to be completed on a monthly basis by all team members who are working on the project. The Lead innovator/executive has to approve all timesheets or designate a representative from the consortium to approve timesheets on his/her behalf. All personnel working on the SANBio/BioFISA II projects will be expected to submit signed timesheets together with the other financial and narrative reports for the project for the end of each milestone (see Annex 4 for timesheet template). 4

4. Management of Intellectual Property 4.1 Recommendations for projects to deal with Intellectual Property in Seed and Flagship Projects For the purpose of the SANBio/BioFISA II Seed and Flagship projects, the Foreground Intellectual Property (IP created during the project) belongs to the consortium who has been awarded funding for implementing the projects (as represented by the organisations and not the individual team members). Neither the donors of the BioFISA II programme nor the CSIR has vested rights in the IP of the grant funded projects. For the scope of the SANBio/BioFISA II funded Seed and Flagship Projects, the Background IP (IP created independently by the project consortium prior to project inception) vests in each partner in the consortium. Foreground IP created during the project has to be shared though an IPR agreement developed by the consortium. All partners are encouraged to define and provide their IPR agreements with their first report, if this has not been finalized at Full Project Proposal stage. It is critical that IP agreements are signed by all parties concerned and the agreements should relate to: IP brought by the partner at the inception of the project (Background IP - prior art, technology, experience/ patents etc.), IP co-discovered and contributed to during the project (Foreground IP), IP created in a limited lifespan, post collaboration period (Postground IP), Exploitation of IP during and at the end of the project, Possible routes for commercialisation and technology transfer if applicable, Use of proprietary know-how, manuals, handbooks, training materials especially in capacity building and training. In most universities and research institutes the IP created in the course of a researcher s career belongs to the institution they work in rather than the researcher or investigator, thus it is important for project implementers to ensure that they have completed due diligence within their institutions and have commenced efforts to identify and secure IP before commencement of their projects in collaborative partnerships and consortia. Furthermore it is critical for project teams to ensure that third party service providers contracted by the consortium and implementing team sign non-disclosure agreements, specifically when contracted to test formulations, conduct technical validation of products or IP due diligence during the course of the project. It is recommended that due to the regional nature of the SANBio/BioFISA II projects, the IP laws of the particular country where the IP was created will govern the protection of the particular IP produced by the consortium partner. The African Regional Intellectual Property Organization (ARIPO) is an intergovernmental organization for cooperation among African states in patent and other intellectual property matters. ARIPO was established by the Lusaka Agreement of 1976. It has the capacity to hear applications for patents and registered trademarks in its Member States who are parties to the Harare (patents), Banjul (marks) and Arusha (plant varieties) protocols. Of the SANBio Member States, the following countries are members of ARIPO Botswana, Lesotho, Malawi, Mozambique, Namibia, Swaziland, Zambia and Zimbabwe. For a detailed list of the IP laws in Southern African countries, please refer to http://www.adamsadams.com/index.php/africa/africaniplaw/. More details on IP protection are provided in Annex 13. 5

5. Financial Management 5.1 Costs supported by the SANBio/BioFISA II Grant SANBio/BioFISA II Flagship and Seed projects are in general supported on a 60/20/20 basis or 70/10/20 (for collaborative calls), where 60/70% of funding will be from SANBio/BioFISA II matched with 20/10% cash and 20% in-kind contributions from the Lead Partner and Co-partners. The project consortium may also contribute more than this minimum level requirement. The funds allocated to the Lead Partner on behalf of the project consortium are to be paid in South African Rand (ZAR) and paid by the CSIR on behalf of SANBio/BioFISA II. The 20/10% cash contribution should be provided in the form of a bank guarantee or bank statement upon contracting. The provision of in-kind goods or services during project implementation should be costed. Both (cash and in-kind contributions) amounts should be auditable. In-kind contributions should amount to at least 20% of the total eligible costs that will be incurred during project implementation. In-kind contributions of consortium members should be monitored during the course of project implementation and should be included in all financial reports. a) Eligible Expenditure Actual running costs incurred for the activities undertaken during project implementation; Training required for the completion of the project; Laboratory equipment (total value less than 5% of the grant contribution); Third party services such as short term consultancies that provide a service or capability that is not available among the project partners (max. 10%); Catering costs (excluding alcoholic drinks) for training workshops Consumables such as stationery; Laboratory consumables, Cost of scaling up or pre-commercialisation of the product; Audit fees; Traveling and accommodation costs must be directly related to the execution of the project in the most economical manner as defined by the Automobile Association rates for travel and a maximum of 4 stars for accommodation; Communication and dissemination costs; Costs of non-permanent staff/students (e.g. Postdocs, MSc and PhD) working on the project. The costs claimed shall not exceed 30% 1 of the overall grant received. Please note that researchers who are on the host institution s payroll as permanent staff members may not claim salary reimbursement from this grant. Maximum of 5 % of the estimated direct eligible costs can reserved as a contingency and can only be used for eligible costs b) In-kind costs In-kind costs provided by the consortium partners (Lead and Co-Partners) include: Specialised equipment/facilities owned by the applicants; Office and laboratory space including utilities; Salaries of the institutions permanent personnel directly involved in the project, calculated in line with the amount of time spent only on the project this includes technical, research and administrative support; Laboratory consumables and reagents; 1 If a grant amount of R4.5 million is requested, up to R1 350 000 can be used to cover the costs of nonpermanent staff/students who are working on the project 6

International and local travel, insurance, accommodation, per diems and subsistence allowance for project personnel; Overhead and administration costs for administering the grant; Pilot or scale up facilities in partner s organisations. c) Ineligible Expenditure Expenditure that is not based on the approved project plan or project and financing decisions issued for the project or which have not been agreed on with the financing authority in project negotiations Debts and debt service charges (interest); Provisions for losses or potential future liabilities; Costs declared by the beneficiary(ies) and financed by another funding agency or projects receiving a grant from SANBio; Purchases of land or buildings and refurbishments, vehicles, equipment, computers Laboratory equipment in excess of 5 % of the grant contribution; Tuition fees of staff members; Long term accommodation for project team members; Fees related to customs clearance; Maintenance costs of equipment; Purchase of office furniture; Entertainment costs and gifts; Currency exchange losses; Grant amount received cannot be used for salary costs of the permanent personnel of institutions (refer to section on In-kind costs above); Overhead costs such as office space, general administration costs (refer to section on Inkind costs above); Management fee; Membership of societies, journal subscriptions etc. 5.2 Project disbursement procedures The Milestone and Disbursement Schedule is defined and an annex to the Grant Agreement. The Lead Partner is responsible for submission of the requisite disbursement requests accompanied by invoices and supporting documents. The first instalment of 20% of the approved grant will be disbursed, if all the requirements have been fulfilled. The following documents should be submitted with the grant agreement for the first invoice to be paid Bank guarantee or the project bank account statement with the 20% cash contribution from partners; Pro-forma invoice (only for the 20 % advance payment); and Work plan and budget for the first milestone. For disbursement of subsequent instalments the Lead Partner submits the following documents: Invoice for the milestone; End-stage report for milestones completed to date, detailed fund utilisation of the grant and in-kind and cash contributions from partners have to be documented. These reports must include all the documented/tangible deliverables and annexes; Work plan and budget for the subsequent milestones. As the disbursements are milestone (results) based, the project management committee has the option to choose how the Lead Partner acting on behalf of the consortium will request the subsequent milestone payments over the duration of the project. 7

The final request for between 10 to 25% of the grant should be accompanied by: Invoice for the milestone; Project completion report with detailed narrative and financial report for the whole project duration, detailed fund utilisation of the grant and in-kind and cash contributions from partners have to be documented; Auditors report and the letter from the auditor with an opinion. The Lead Partner must be registered as suppliers on the National Treasury website and then on the CSIR Supplier Registration system, visit (www.csd.gov.za). The funds allocated to the project team is expressed in ZAR and paid by the CSIR. For each disbursement, the Lead Partner will have to present an invoice addressed to the CSIR (see Annex 5). Each request for disbursement shall be submitted with: Progress report covering the agreed reporting period with the narrative description of the results/milestones achieved for specific period, Detailed financial report indicating expenses incurred in relation to the grant received for each project partner, and in-kind and cash contributions from partners (refer to Section 6.3). All financial reports must include a summary list of costs including copies of legally acceptable invoices and vouchers, in relation to the invoiced items. Originals will be retained with the Lead Partner and Co-Partner for audit purposes. The financial request for future planned activities in line with project deliverables must indicate the nature of expense and the partner receiving the funding. A sample of an invoice to be submitted to the CSIR is available in Annex 5. The payment request shall be prepared by the LP, signed by the authorized person and sent to the SANBio/BioFISA II offices in hard copy. Unless the project implementing partners inform the BPU of any delays in receiving the disbursed funds, the assumption will be that the projects have received the funds in a timely manner. 5.3 Project funding disbursed to Co-Partners The CSIR will only make payments to the Lead Partner and it is the responsibility of the Lead Partner to provide funding from the grant to the Co-Partners who are also carrying out project implementation. The Lead Partner should obtain the necessary National Treasury/Reserve bank approvals for funds and material transfers across the borders. The Lead Partner should also account for all the funds and materials and goods transferred to their partners and report on them together with their own expenditure. All Co-Partners should adhere to and follow the financial guidelines and procurement guidelines as stated in this PIG. 5.4 Record keeping, monitoring and control for project finances It is imperative that the project team be able to account for all financial transactions carried out in the course of project implementation. In financial reporting the following instructions have to be followed: a) All expenditures related to the Project, regardless of the source of funds, from Lead Partner, consortium members, other funder or SANBio/BioFISA II, have to be reported; 8