4.1.1 Negotiating, drafting or reviewing variety of corporate transactions or commercial contracts (including negotiating commercial contracts with international suppliers, customers and back up supply agreements). This include advising on other aspects such as competition law risks involved. Providing advice on contract legal risks and termination, as well as legal support in commercial transaction of varying complexity.
4.1.2 The major transactions and commercial agreements that Sam is or was involved in, include the following:
4.1.2.1 Nuclear and Radiopharmaceutical Products Commercial Agreements: Advising, reviewing and preparation of commercial agreements, sales agreements, quality agreements and irradiation agreements in respect of radiopharmaceutical products such as Mo-99 Molybdenum, Fission Molybdenum, cold kits, Fission Iodine I-131 capsules, Tc-99 Generators and other pharmaceutical products including preparation of Sales Agreements between NTP Radioisotopes SOC Ltd and amongst others, the following international entities: Australian Nuclear Science and Technlogy Organisation (Australia), Ansto Nuclear Medicine (Pty) Ltd (Australia), Curium Pharma (Netherlands), Global Medical Solutions (Cayman Islands), Enviro Korea Co. Ltd (Japan), CGM Nuclear SA (Chile), Chengdu Gaotong Isotope Co. Ltd (Beijing), Fujifilm Toyama Chemical Co. Ltd (Tokyo), PDRadiopharma Inc (Japan), Importrans Radiactivos LTDA (Colombia), San Young Unitech (South Korea), Gamma Trade Egypy (Egypt) and others. Reference in respect of the commercial agreements above: Ms Annette Lubbe: Executive Manager: Sales & Marketing – NTP Radioisotopes SOC Limited; Email: annette@ntp.co.za ; Tel: 012 305-5685 / 083 375 939
4.1.2.2 License Agreement between ITM Isotope Technologies Munich SE (Garching, Germany) and ITM Medical Isotopes GmbH (Garching, German) and NTP Radioisotopes SOC Limited relating to the manufacture and use of non-carrier added Lutetium-177 under the Technology Transfer Agreement between ITM Medical Isotopes GmbH (formerly, ITG Isotope Technologies Garching GmbH) and NTP Radioisotopes SOC Limited. The agreement includes the granting of the license to use patent rights, know-how to manufacture and distribute the product in the relevant territories. The Contract provided for the payment of royalties on Product Net Revenues for Licensed Product. Agreement signed and finalized in March 2024. Reference: Ms Annette Lubbe: Executive Manager: Sales & Marketing – NTP Radioisotopes SOC Limited; Email: annette@ntp.co.za ; Tel: 012 305-5685 / 083 375 939
4.1.2.3 A Molybdenum-99 Distribution Agreement between NTP Radioisotopes SOC LTD (“NTP”) and Australian Nuclear Science and Technology Organisation (“ANSTO”) and Ansto Nuclear Medicine (“ANM”) (AUSTRALIA) in respect of the appointment of NTP as an exclusive distributor of Molybdenum-99 and other radiopharmaceutical products in all countries other than Australia and New Zealand. This included rendering an advice in respect of, inter alia, the IP Agreement concluded between the parties, regulatory and compliance on Good Manufacturing Practices and others. Advising on obtaining regulatory approvals in international countries such as the United States before selling, importing, distributing, exporting or marketing radiopharmaceutical products. Ref: Ms Annette Lubbe: Executive Manager: Sales & Marketing – NTP Radioisotopes SOC Limited; Email: annette@ntp.co.za ; Tel: 012 305-5685 / 083 375 939
4.1.2.4 Quality Agreement: ITM Medical Isotopes GmbH (Garching, German) and NTP Radioisotopes SOC Limited: Product quality agreement pertaining to the manufacture, packaging, labelling, testing and transport of medical isotopes. Advising on compliance with, inter alia, German Drug Laws as well as FDA Guidance and SAPHRA. Ref: Ms Annette Lubbe: Executive Manager: Sales & Marketing – NTP Radioisotopes SOC Limited; Email: annette@ntp.co.za ; Tel: 012 305-5685 / 083 375 939
4.1.2.5 Master Supply Agreement relating to the supply of Molybdenum (Sodium Molybdate) between NTP Radioisotopes SOC LTD ("NTP") and GE Healthcare (Buckinghamshire, United Kingdom) for the period July 2023 to December 2024. Agreement finalized and signed in June 2023. Ms Annette Lubbe: Executive Manager: Sales & Marketing – NTP Radioisotopes SOC Limited; Email: annette@ntp.co.za ; Tel: 012 305-5685 / 083 375 939
4.1.2.6 Molybdenum-99 Distribution Agreement between NTP Radioisotopes SOC LTD ("NTP") and Australian Nuclear Science and Technology Organisation ("ANSTO") and Ansto Nuclear Medicine ("ANM") in respect of the appointment of NTP as an exclusive distributor of Molybdemim-99 in all countries other than Australia and New Zealand. This included an advice in respect of, inter alia, the IP Agreement concluded between the parti Advising parties regarding the transfer of a contract from a parent company to a subsidiary entity and preparing a Cession Agreement between Fujufilm Toyoma Chemical Co. Ltd (“FFTC”) (Tokyo), PDRadiopharma Inc (“PDR”) (Japan) and NTP Radioisotopes SOC LTD (“NTP”) (“South Africa) in terms whereof FFTC ceded, delegated and assigned all its rights and obligations and duties (under the main sales agreement concluded between NTP and FFTC) to its newly established subsidiary company, PDR.
4.1.2.7 Commercial Sales Agreement between NTP Radioisotopes SOC LTD and Global Medical Solutions LTD (AUSTRALIA): Attending to prepare a Sales Agreement in respect of the sale and supply of Fission lodine-131 by NTP Radioisotopes to Global Medical Solutions and its various subsidiaries in the Thailand, Australia, Taiwan, Philippines. This include preparation of the company Resolutions to be adopted by each of the various subsidiaries in adopting the main sales agreement. Preparation of the Quality Agreement which specifies the GMP requirements as per the Guide for Good Manufacturing Practice for Medical Products as set forth in the Code of the Federal Regulations of the U.S and Drug Administration, the Rules Governing Medicinal Products in the European Community and GMP Requirements
4.1.2.8 Non-Exclusive Distribution Agreement between AEC Amersham SOC LTD and Mirion Technologies (Capintec) Inc (USA): Drafting and reviewing Distribution Agreement in respect of the appointment of AEC Amersham as a non-exclusive distributor of products for sale and sell in South Africa. Ref: Mapula Tshetlhane: Managing Director of AEC Amersham SOC Limited: Email: Mapula@aecam.co.za 0725240485 / (011) 691-6500
4.1.2.9 Competition Legal Opinion in respect of the agreement and/or arrangements between NTP Radioisotopes SOC Ltd ("NTP") and its exclusive distributor and subsidiary, Gammatec NDT Supplies SOC Ltd ("Gammatec") and following the Competition Commission having cautioned Pelchem SOC, a subsidiary of NECSA, against the practice of exclusive licences in respect of products for which Pelchem is the sole supplier or producer.