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. Classical, know-how, and hybrid i. Service by TBSE

b. Match making, technology ii. Service by BCIL

information, financial syndication

c. RET bank iii. Type of license

d.DBT JRF, DBT BINC iv. TIFAC

e. Vision 2020 v. BCIL

f. Inaugrated in 1990 by PM of India, vi. APCTT

Honourable Shri Chandra Shekhar

17. Fill in the blanks

a. The office of BCIL is at ____________.

b. Global tech database gives desired result in case __________ does not give.

c. Setting of trade rules and controlling imports and exports are main function

of _________.

d.BCIL stands for ___________.

e. TBSE stands for ___________.

ANSWERS

1. d 2. d 3. b 4. e 5. d 6. a 7. a 8. a

9. c 10. b 11. c 12. b 13. c 14. c 15. d

16. a(iii), b(i), c(vi), d(ii), e(iv), f(v)

17. (a) New Delhi (b) Asia-Pacific Technology Transfer Market Service for SMEs

(c) WTO (d) Biotech Consortium India Limited (e) Technology Bureau for Small

 Enterprises.

 

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

production. For the economic growth, a product or service should be exposed to the

marketplace.

A single department is not involved in carrying out technology transfer. It is a

combined task which involves research and development (R&D), quality assurance

(QA) and quality control (QC), administrative staff, supporting staff, etc. of developer

as well as a secondary unit. As we know that technology transfer is a systematic process

which involves various stages. A successful and productive technology transfer requires

the support and effort of different departments.

Basically, there are four steps involved in transfer of technology:

1. Research phase

2. Development phase

3. Production phase

4. Documentation

Technology transfer dossier contains the following documents

i. Master formula card

ii. Master formula

iii. Standard test procedures

iv. Specifications

107

 

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. ICH

c. CDSCO d. All of the above

Regulation of Transfer of Technology 105

2. Which of the following is not a function performed by R&D in TOT:

a. Supports technical issue

b. Directs and trains the procedural trial at RU

c. Resolves technical problems

d. Regulatory filing

3. Which of the following organisation issues regulation for protecting intellectual

property rights during TOT:

a. WTO b. WIPO

c. WHO d. ICH

4. WTO performs which of the following functions during TOT:

a. Set trade rule

b. Control trading

c. Set excise duty

d. Monitor import and export of products

e. All of the above

5. Which of the following is not among 5 Cs that are essential for success of TOT:

a. Co-ordination b. Capacity

c. Co-operation d. Chasing

6. NCL is situated at:

a. Pune b. Nagpur

c. Delhi d. Chennai

7. APCTT headquarter is situated at:

a. Delhi b. Mumbai

c. Bangalore d. Chennai

8. APCTT works under:

a. ESCAP b. ESPAC

c. CDSCO d. WTO

9. Which of the following is not among objectives of APCTT:

 

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 describes the details about the parties to the

agreement.

3. The period: It is essential to specify a period for the partnership with dates.

4. Assignments/responsibilities: This important section of the MoU describes the duties

and responsibilities of each party. It is generally more effective to describe each

organization’s responsibilities separately, the organization’s sole responsibility, each

group’s sole responsibilities, shared responsibilities, etc.

5. Disclaimers: While drafting, MOUs must contain one or more disclaimers for

different conditions, e.g. guarantee, attestation, declaration, etc.

6. Financial arrangements: Financial implications should be described in detail

including what to pay and to whom.

7. Risk sharing: It is essential to mention in MoU that who will bear the risk of a

mishap.

8. Signatures: A representative from each partner with authority should sign the MoU.

And retain a copy of the signed agreement.

6.5.4 Legal Issues

The technology transfer process should be per the legal framework and jurisdiction of

the concerned country. Issues like tax, intellectual property rights, infringement of

contract, failure to comply with regulatory guidelines come under legal issues.

Mentioning of recommended law and jurisdiction in case of breach of conditions in

the agreement should be there in the technology transfer agreement.

Checklist for the technology transfer agreement is as follows:

Preliminary statements

i. Identification of the parties

ii. Purpose

iii. Effective date of the agreement

iv. Whereas clauses (recitals, preamble)

v. Licensor representations

vi. Licensee representations

vii. Background of the agreement

viii. Definition of terms

Subject matter of the license

i. The license grant

ii. Patent rights

iii. Exclusivity

iv. Territory

v. Rights conferred

vi. Limitations

vii. Maintenance and prosecution of the patents

viii. Infringement

ix. Patent marking

x. Know-how/trade secrets/confidential information

xi. Technical assistance

xii. Plant visits and training

xiii. Direct assistance.

104 Industrial Pharmacy II

xiv. Consultation

xv. Improvements

xvi. Sublicense rights

xvii. Initial payment

xviii.Royalties

xix. Separate payments for patents and know-how

xx. Acquisition of machinery

xxi. Technical services

xxii. Term of the license agreement

“Boilerplate” Provisions

i. Termination of the agreement

ii. Best efforts

iii. Most favoured licensee

iv. Warranty and identification

v. Export control

vi. Arbitration and applicable law

vii. General provisions

 

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 selective basis interest-free

loan to meet initial expenditure in the pre-technology absorption stage.

Regulation of Transfer of Technology 99

Business Collaboration

The Bureau offers support to small enterprises for the export of technologies and the

products manufactured by them through business tie-ups as a part of the package. To

promote international cooperation amongst SMEs, the Bureau organises overseas visits

of business delegations.

Support Services

It arranges consultancy services, visits of overseas experts for in-plant counselling:

coordinates buyer–seller meets for specific product-process technologies and represents

the business interests of small enterprises in international events.

6.5 TOT RELATED DOCUMENTATION

6.5.1 Confidentiality Agreements

A confidentiality agreement is also known as a non-disclosure agreement. It is a contract

between two or more parties where the aim/subject of the agreement is a guarantee

that information transfer will be maintained in confidential/secrecy.

These agreements can be mutual or can be unilateral agreements. Mutual

confidentiality agreements are useful for inventor groups where both parties share

confidential information. On the other hand, unilateral confidentiality agreements,

are used when only one party is turning over confidential information, e.g. in the

innovation area to a prospective licensee.

These types of agreements are very much useful in TOT. The use of a confidentiality

agreement means that those who receive the information are obligated to maintain

the information in secret legally. The confidential agreements should be in writing.

However, while some court cases in some jurisdictions do allow oral creation of such

a confidential relationship but it is not recommended to rely on the oral confidential

agreement.

 

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

viii. The recipient may be required to divulge information to a Court of Law

ix. Penalties defined for breach of confidentiality

Checklist for confidential agreements

1. Parties: Ensure that correct legal name and address is used.

2. Recitals: Describe the specific situation of the disclosure of confidential information.

Recitals may not be legally binding.

3. Subject of the agreement/information: Ensure that the subject matter and purpose

of the disclosed information is correctly identified and described.

4. Scope of confidential information: Check interests of both parties.

5. Use of the information by receiving party: Add obligation to keep the information

confidential, not disclose to third parties without prior written consent and to use it

only for the defined purpose.

6. Term and termination: Effective date for start of the contract and its time limit

should be mentioned.

7. Governing law and jurisdiction: Mention recommended law and jurisdiction in

case of breach of conditions in the agreement.

8. Miscellaneous: Wording to clarify that neither party is obliged to negotiate or enter

into any further agreement or any other condition, if needed.

9. Signatures: Signatures of both the parties/witnesses/any other designated authority

should be there.

6.5.2 Licensing

In this type the owner/developer of the technology grants permission to another

company (receiver/absorber) in the form of license to use the technology for certain

purposes and for a certain period (Fig. 6.4).

Fig. 6.4: Types of licensing agreement

Regulation of Transfer of Technology 101

By a technology licensing agreement the licensor authorizes the licensee to use the

technology under certain agreed terms and conditions. It is, therefore, a contract freely

entered into between two parties and contains terms and conditions so agreed.

The rights conferred by the license are as follows:

i. Technology/patent: To make, sell, import, export, use

 

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, under

an Act of Indian Parliament, presently acts as the principal financial institution for the

promotion, financing and development of the micro, small and medium enterprise

(MSME) sector and also co-ordinates the functions of the institutions engaged in similar

activities. As on March 31, 2012, the authorised capital of SIDBI is 1000 crore and

paid-up capital is 450 crore. Presently, the Bank provides refinance support through a

network of eligible member lending institutions for onward lending to MSMEs and

direct assistance is channelized through the Bank’s branch offices. SIDBI also extends

financial assistance in the form of loans, grants, equity and quasi-equity to nongovernment organisations/micro finance institutions (MFIs) for on-lending to micro

enterprises and economically weaker sections of the society, enabling them to take up

income-generating activities on a sustainable basis.

The important features of TBSE services are:

i. Offers a professionally managed system for technology and collaboration search.

ii. Helps in building up confidence between prospective partners.

iii. Lends a friendly hand in the intricate task of negotiations and matching of

perceptions.

iv. Provides a gateway to the global technology market through networking.

v. Unique mechanism for arranging technology and finance.

vi. Takes up project appraisal and preparation of a business plan.

 

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 task forces covered areas of agro-food processing, waterways, road

transportation, civil aviation, electric power, telecommunications and advanced

sensors. The panels were on food and agriculture, engineering industries, healthcare,

life sciences and biotechnology, materials and processing, service, strategic industries,

electronics and communication, chemical process industries, and driving forces and

impedances.

Regulation of Transfer of Technology 97

The technology vision 2020 reports provided the technology status, forecasts

and assessment of respective sectors. They also identified short-, medium- and

long-term technology priorities for the country and suggested ways to implement

them.

6.4.4 BCIL (Biotech Consortium India Limited)

BCIL was inaugurated in 1990 by the then Prime Minister of India, Hon'ble Shri Chandra

Shekhar. Biotech Consortium India Limited (BCIL) is a public limited company,

promoted by the Department of Biotechnology (DBT), Ministry of Science and

Technology, Government of India and all India financial institutions for providing the

necessary linkages among stakeholders and business support for facilitating accelerated

commercialization of biotechnology.

The Board of Directors of BCIL consists of senior representatives of DBT, Council of

Scientific and Industrial Research (CSIR), Indian Council of Agricultural Research

(ICAR), leading all India financial institutions and the biotechnology industry.

The office of BCIL is at Biotech Consortium India Limited, V Floor, Anuvrat Bhawan,

210, Deen Dayal Upadhyay Marg, New Delhi 110002.

Functions

BCIL has been actively involved in technology transfer, project consultancy, fund

syndication, information dissemination, and manpower training and placement related

to biotechnology over the last decade and a half.

It has assisted hundreds of clients including scientists, technologies, research

institutions, universities, first entrepreneurs, the corporate sector, national and

international organizations, central government, various state governments, banks and

financial institutions. Services offered by BCIL (Fig 6.3)

 

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 regular session of the council. The chair or in his/her

absence, the vice-chair shall preside at meetings of the council. If the chair is

unable to serve for the full term for which he/she has been elected, the

vice-chair shall act as chair for the remainder of that term.

vii. The council shall advise on the formulation and implementation of the programme

of work of the centre and review the administration and financial status of the

centre. The Executive Secretary shall submit an annual report, as adopted by the

council, to the commission at its annual sessions.

Functions

i. APCTT promotes the technology transfer in the Asia-Pacific Region by its ICTbased networks, platforms and its advisory services.

ii. The main emphasis is on promoting cross-border business cooperation between

small and medium scale enterprises (SMEs) and facilitating technology-based

business partnerships.

Regulation of Transfer of Technology 93

It has Three Online Technology Support Mechanisms

1. Asia-Pacific Technology Transfer Market Service for SMEs: It acts as an information

exchange platform for SMEs related to technology transfer, it is free of cost service.

It gives information regarding:

i. The technology available for transfer

ii. Technology needed

iii. Opportunities for business cooperation

2. Global technology database: It has a technology database country-wise for SMEs

and entrepreneurs. It is an extended version and gives the desired result in case

Asia-Pacific Technology transfer market service for SMEs do not give.

3. Renewable energy technology bank (RET Bank): Its main objective is to facilitate

TT co-operation among countries in the Asia-Pacific region in the field of renewable

energy. It is data bank of Renewable Energy Technologies in area of solar, biomass,

hydro, wind, geothermal energy, etc. It is freely available for public access.

APCTT offers technology transfer promoting services to technology providers and

seekers. It is done by partnering with its technology transfer intermediary networks

and national focal points. Some important technology transfer facilitation services of

APCTT include:

 

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 transfer organization in India.

Mission:

i. To promote, develop, nurture and commercialize innovative, reliable and

competitive technologies from R&D institutes through value addition and

partnership

ii. To sensitize R&D institutions and industry about technologies that need to be

developed and commercialized.

Organisational flowchart (Source: NRDC): Details shown in Flowchart 6.1

i. Minister: Dr. Harsh Vardhan, Hon’ ble Union Minister, Science and Technology

and Earth Sciences

ii. Secretary: Dr. Shekhar C. Mande, Director General, CSIR and Secretary, DSIR

(Note: The name of persons in the flowchart subjected to change from time to time)

94 Industrial Pharmacy II Flowchart 6.1: Organisational flowchart of NRDC

Regulation of Transfer of Technology 95

Achievements of NRDC

i. NRDC has developed strong links with the scientific and industrial community

in India and abroad.

ii. It developed a wide network of research institutions, academia and industry.

iii. It made formal arrangements with institutions, academia and industry for the

commercialisation of know-how developed in their laboratories

iv. It is now recognised as a large repository of a wide range of technologies spread

over almost all areas of industries, viz. agriculture and agro-processing, drugs

and pharmaceuticals, bio-technology, metallurgy, etc.

v. It has licensed the indigenous technology to more than 4800 entrepreneurs.

vi. NRDC has also successfully exported technologies and services to both developed

as well as the developing countries.

vii. NRDC is recognised, mainly in developing countries, as the source of reliable

appropriate technology, machines and services.

6.4.3 TIFAC (Technology Information Forecasting and Assessment Council)

As per the recommendation of Technology Policy Implementation Committee (TPIC)

in 1985, cabinet approved the formation of TIFAC in mid-1986 and TIFAC was formed

as a registered society in February 1988 under the Department of Science and

Technology as an autonomous body. The office of TIFAC is at Technology Information

Forecasting and Assessment Council, Department of Science and Technology (DST),

‘A’ Wing, Vishwakarma Bhavan, Shaheed Jeet Singh Marg, New Delhi 110016, India.

TIFAC activities encompass a wide array of technology areas and fill a critical gap

in the overall S&T system of India. The organization has carried out technology

foresight exercise, facilitated and supported technology development, prepared

technology linked business opportunity reports and implemented mission-mode

programmes.