topics / مواضيع

  a. To develop technology b. To improve terms of TOT c. To give approval to new drugs d. To assist ESCAP 10. NRDC was established in: a. 1977 b. 1953 c. 1990 d. 1982 11. NRDC works under: a. HRD ministry b. CDSCO c. Ministry of science and technology d. WHO 12. TIFAC stands for: a. Technical information formation and assessment council b. Technology information forecasting and assessment council c. Technology implementation formation and assessment council d. None of the above 13. TIFAC was approved in: a. 1980 b. 1985 c. 1986 d. 1991 106 Industrial Pharmacy II 14. A contract between two or more parties where the aim/ subject of the agreement is a guarantee that information transfer will be maintained in secrecy: a. MoU b. DMF c. Confidentiality agreement d. Legal document 15. Which of the following is one of the checklists for confidential agreements: a. Signatures b. Term and termination c. Parties and recitals d. All of the above 16. Match the following Information Belongs to a. Cl

  TECHNOLOGY In pharmaceutical sciences generally technology also refers to pharmaceutical technology, which involves scientific aspects that are important and critical in the development as well as manufacturing of new drugs, dispensing methods, manufacturing of medical devices, etc. TECHNOLOGY DEVELOPMENT It is the systematic use of scientific, economic, technical and commercial knowledge to meet a specific set of goals and requirement. TECHNOLOGY TRANSFER Technology transfer is a collaborative process which involves the transfer of all types of documents, knowledge, experience related to all aspects of technology. It also involves the transfer of legal rights (intellectual property rights). TECHNOLOGY TRANSFER IN PHARMACEUTICAL SCIENCES Technology transfer ensures the transfer of knowledge, techniques and experience required for the manufacturing of quality drug product. It is a carrier which carries quality drug product from its laboratory-scale production to commercial-scale produ

  viii. Assignment ix. Severability x. Entire agreement xi. Force majeure, contingencies xii. Notices All the legal issues can be handled properly if the technology transfer agreement is prepared as per the checklist and documentation is done as per the guidelines. PRACTICE QUESTIONS Long Answer Type Questions 1. Describe the authorities and agencies involved in transfer of technology. 2. Explain in detail about the TOT agencies in India. 3. Explain confidential agreement and MoUs related with technology transfer in detail. Short Answer Type Questions 1. “Technology transfer team is a multidisciplinary team”, support the statement. 2. Describe the problems faced during commercialisation of technology. 3. Discuss various cases related with technology transfer. 4. Explain the functions, vision, and mission of: a. APCTT, b. NRDC, c. TIFAC 5. What is licensing agreement? Discuss in detail. Objective Type Questions 1. Which of the following authorities are involved in TOT a. WTO and WIPO b.

  xxiii. Risks xxiv. Confidentiality xxv. Amendments xxvi. Closing, signature, date and place xxvii. Date of effectiveness 6.5.3 MoU MoU (Memorandum of Understanding) is also known as commitment letter or letter of intent. It is used: i. At the start of license negotiations and it has mutual conditions as specified by both the parties. ii. When receiving party is showing serious intention to sign a license with another party. iii. To motivate and speed up the transfer process. iv. It is a non-binding document and has no legal obligations. However, may have legal obligations some time in case of: • Binding by default status • Indicating binding/not binding status. Requirements of MoU 1. State the overall aim of the MoU: Many MoUs begin with a short description of the overall aim/goal of the parties. MoUs should have clearly stated clauses that accurately reflect the intentions of parties involved. Regulation of Transfer of Technology 103 2. The parties: The next clause in an MoU describ

  Range of Services Technology Information The Bureau has a large computerised database on technology options available from different countries. It gives the user updated information on sources of technologies and means of accessing them. Also, background information on technology-seeking enterprises is maintained and made available to interested technology suppliers and collaborators. Match Making It identifies business partners willing to collaborate, brings them face to face and extends support to tie up financial assistance and other requirements for the transfer of technology and joint ventures. Collaborating partners are further assisted in drafting agreements, obtaining various approvals and preparation of business plans. Finance Syndication Depending on the cost of project, nature and quantum of assistance required, the Bureau undertakes financial syndication through SIDBI covering term loans, foreign currency, venture capital, lines of credit, equity assistance and on selecti

  It can be used: i. Before patenting the technology ii. After patenting the technology Information is not considered as confidential if: i. It is in public domain by any means and entered in the public domain other than the fault of the receiving party. ii. If the disclosing party has access to its disclosure to the third party without restriction. iii. It is developed independently by the receiving party. iv. It has to be disclosed by laws and regulations. Main characteristics of confidentiality agreement: i. Each “provider” retains all ownership rights in its information. ii. Information can also include tangible objects. iii. Provides for disposition of the information at the termination of the agreement iv. Duration is up to the parties v. No warranties on use of the information vi. No implied license or other use beyond that expressly defined 100 Industrial Pharmacy II vii. The recipient may be relieved of obligation if the information becomes public through no fault of their own

  i. Technology transfer ii. Project consultancy iii. Certification services iv. Information services v. Biosafety vi. Biotech industrial training programme vii. Project management viii. DBT JRF ix. DBT BINC (bioinformatics national certification) Fig. 6.3: BCIL methodology for technology transfer 98 Industrial Pharmacy II 6.4.5 TBSE (Technology Bureau for Small Enterprises)/SIDBI (Small Industries Development Bank of India) The technology bureau for small enterprises under Ministry of Micro, Small and Medium enterprises provides a platform for small enterprises that can tap opportunities at the global level for the acquisition of technology or establish business collaboration. Resulting from the joint initiative of the United Nations' Asian and Pacific Centre for Transfer of Technology and Small Industries Development Bank of India which represents under one roof the synergy of technology and finance. Small Industries Development Bank of India (SIDBI), set up on April 2, 1990, und

  In November 1993, the TIFAC Governing Council felt that the dream for a developed India can only be realized through technological strength. TIFAC took up the responsibility of creating a Technology Vision for the country that would catalyze and guide national initiatives in Science and Technology. The objectives of the exercise were: i. To provide directions for national initiatives in science and technology to realize a vision for India up to 2020 ii. To provide a strong basis for policy framework and investment for R&D in the government and the private sector iii. To contribute to the development of an integrated S&T policy both at the state and national levels. The nationwide exercise spanned over three years and includes: i. 7 task forces and ii. 10 panels drawing 500 experts from industry iii. Government and R&D institutions. iv. About 5000 experts from across the country participated in the exercise through their responses to questionnaires, workshops, etc. The tas

  The members and associate members elected by the commission shall be elected for three years but shall be eligible for re-election. The executive secretary or his/her representative shall attend meetings of the council. iii. The director of the centre shall serve as secretary of the council. All member states and associate members of UNESCAP are de facto members of APCTT. iv. Representatives of: (a) States that are not members of the council, (b) United Nations bodies and specialized and related agencies and (c) such other organizations as the council may deem appropriate, as well as experts in fields of interest to the council, may be invited by the Executive Secretary to attend meetings of the council. v. The council shall meet at least once a year and may adopt its own rules of procedure. A quorum for meetings of the council shall be a majority of its members. vi. The council shall, at each regular session, elect a chair and vice-chair. They shall hold office until the next regula

  i. Providing information on technology transfer, joint-venture, business/research partnerships and opportunities. ii. Organizing business-to-business meets. iii. Technology exhibitions and technology transfer related conferences and technology dissemination workshops in partnership with APCTT focal points in the member countries. iv. Providing support services to help techno-entrepreneurs interact with technology transfer intermediaries, source technology globally, and also explore venture capital financing. 6.4.2 NRDC National Research Development Corporation (NRDC) was established in 1953 by the Government of India. Its primary objective is to promote, develop and commercialise the technologies /know-how/inventions /patents /processes emanate from various national R&D institutions/universities. It is presently working under the administrative control of the Department of Scientific and Industrial Research, Ministry of Science and Technology. Vision: To be a leading technology t