NATIONAL BIODIVERSITY AUTHORITY

- National Biodiversity Authority

• High production technologies and mixed cropping systems were developed for increased productivity per unit area of land. The long-term effect of weather on productivity of black pepper was studied.
• The production physiology of spice crops is being studied. Biosynthetic pathways for curcuminoids in turmeric was elucidated and phenyl alanine ammonia lyase, the major enzyme initiating the synthesis of curcumin was characterized.
• The distribution, incidence, epidemiology, characterization and crop loss caused by pests and pathogens were studied. Sensitive diagnostics for detection of pathogens of spice crops has been developed. A National Repository of Phytophthora collections from various hosts has been established.
• Eco-friendly integrated strategies involving cultural methods, biocontrol agents, natural products and resistant varieties were developed for the management of pests and diseases that resulted in substantial increase in yields and pesticidefree produce.
• A Repository of Bio-control Agents consisting of bacteria and fungi was established to conserve, characterize and document the variability and potential of bio-control agents. Potential bio-control agents were identified against major pathogens including nematodes and technologies for their mass multiplication were developed.
• Post-harvest technologies for processing black pepper and cardamom and preparation of value added products such as white pepper and salted ginger were standardized. Drying techniques for nutmeg, mace and cinnamon were also standardized.
• Large scale demonstrations of technologies developed by the institute were carried out in farmers fields and its impact in increasing the productivity of major spices was studied. Record of the discussions agenda wise is as follows:-

FIFTH MEETING OF THE NATIONAL BIODIVERSITY AUTHORITY
Administrative Matters for Discussion 1

. APPROVAL OF APPLICATION RECEIVED BY NBA
Twenty three applications have been received by the NBA for approval for according permission under the Biodiversity Act, 2002. The Act stipulates only 90 days for processing and according approval. There are however many other conditions to be followed such as 1. Recommendation of local Bodies: All Local Bodies have not been formed.
2. The list of Normally Traded Commodity (NTC) under Section 40 is yet to be finalized. 3. The exact parameters under which each application has to be approved should be notified as "Regulations". 4. The Guidelines for Access and Benefit sharing as a "Regulation" has not yet been made. However NBA cannot wait indefinitely till all the regulations were notified. Therefore the Authority is of view, that it will give approval to all the applications based on the recommendations of the Expert Committee. The Authority will however follow all procedures in future cases.
Following are applications approved as per the comments of the Expert Committee as well as the decision taken by the Authority in its 5 th meeting: Comments: An agreement prepared by NBA will be signed by the party for benefit sharing as well as not transferring the material to third party.

The Authority is requested to approve
Approved by NBA as per the comments given by the Expert Committee The committee has recommended the following: 1. Species access by the applicant to be scaled down probably 30 accessions per species. 2. Geographical location of India to be motioned. 3. The form in which the process is executed is to be mentioned. 4. The committee agrees in principle that such transfer may be executed only on well laid down guidelines including IPR's.
Comments: A letter to this effect may be written to IFF, Chennai get all the particulars mentioned above. This application may be approved with permission to access 30 accessions with an agreement an IPR and Benefit sharing. Transfer of material outside India is not permitted by the committee and the screening or bio prospecting may be done preferably in India with an Indian counterpart.

The Authority is requested to approve
Approved by NBA with other condition prevailing in other acts. Instead of 30 accessions only 50 gm is allowed. Comments: The research is to be carried out by an Indian Dr Moushumi Sen Sharma with Dr Gene E Robinson, USA. An agreement prepared by the NBA for not transferring the material to third party and any commercial benefit to be shared to be executed.
The members of the Authority did not approve the proposal in the present form unless a reply from Prof Dr Brij Gopal that his university is collaborating with the applicant. The committee has recommended the application for approval with the following comments:

Reference
1. To deposit the materials collected in the designated repositories and document to state the claim of national sovereignty. 2. The committee recommends the project for approval.

Government approved (INDO-FRENCH DEPARTMENT OF SCIENCE TECHNOLOGY supported) Collaborative research Proposal.
Please find an Indian collaborator to be identified by the applicant to get the approval as well as the agreement executed by the NBA.
The Authority is requested to approve Approved NBA as per the comments given by the Expert Committee The committee has recommended the application with the following conditions: 1. The committee recommends the project. 2. The research may be restricted to South India. 3. Only 500 specimen to be permitted instead of 2000 species. 4. No more than 3 species from each locality will be permitted. 5. Indian collaborators confirmation to be obtained before permitting the project.
A letter to this effect from NBA to clarify the collaboration will be written. As well the above conditions mentioned by the committee will be intimated to the applicant. Agreement on access for research will be executed by NBA in this regard. The IPR claim on material and knowledge to be vested with the Indian Collaborator On 12 th Dec, 2005 a letter was received from the Company Secretary in connection with seeking approval from the NBA for patent application. In their letter they have confirmed that they will accept the terms and condition as stipulated in the BD Act, 2002. To this effect a reply letter was written in consultation with the Legal Consultant of NBA.
The Authority is requested to approve Approved by NBA as per the comments given by the Expert Committee 1. Comments to be sought from NIO for collaboration. 2. Permission to collect the Schedule 1 corals will be necessary from concerned authority.
A letter to this effect will be written to NIO for collaboration as well as the permission to collect coral obtained under Wildlife Act 1972 from MOEF from the applicant. Type of application: Form II Bioresource: Parental seeds of Eggplants COMMENTS: The Cry 1AC gene has been transferred in to an important egg plant from Bengladesh since the source population of RHR-51 has come from MPKV, Rahuri the benefit sharing may be ensured through an agreement and the concerned party ie MPKV, Rahuri may be accordingly intimated. Since this is GM crop the GEAC, Ministry of Environment appropriately may be informed. The proposal was submitted to NBA through CEAC. The committee recommended the proposal.
The Authority is requested to approve 16 COMMENTS: The Cry 1AC gene has been transferred in to an important egg plant from Bari since the source population of RHR-51 has come from MPKV, Rahuri the benefit sharing may be ensured through an agreement and the concerned party ie MPKV, Rahuri may be accordingly intimated. Since this is GM plant the GEAC, Ministry of Environment appropriately may be informed. The proposal was submitted to NBA through GEAC. The committee recommended the proposal.
The authority is requested to approve COMMENTS: The Cry 1AC gene has been transferred in to an important egg plant from Los Banos (UPLB)-Philippines since the source population of RHR-51 has come from MPKV, Rahuri the benefit sharing may be ensured through an agreement and the concerned party ie MPKV, Rahuri may be accordingly intimated. Since this is GM plant the GEAC, Ministry of Environment appropriately may be informed. The proposal was submitted to NBA through GEAC. The committee recommended the proposal.

The authority is requested to approve
It was approved by the authority. However, a letter to be addressed to the VC/Director of research to clarify whether they have undertaken an agreement for benefits sharing mechanism. If not the University should enter into an agreement for benefit sharing. The MAHYCO should monitor the third party Transfer. The committee recommended and approved the project. ACTION The members also of the opinion that proposal for awareness programmes less than Rs. 5 lakhs (Rs five lakhs) need not to be brought to the Authority meeting and only proposal above Rs 5 lakhs (Rs. Five lakhs) to be brought to the authority for approval. • To establish the relationship between the extent of oxidation and Base Metals' recovery,

APPROVAL OF TERMS OF REFERENCE ON THE PREPARATION OF GUIDELINES BY EXPERT COMMITTES
• To determine the acid balance for biooxidation of the Vedanta concentrate in the GEOCOAT ® system, • To investigate the removal of iron from the biooxidation effluent solution by precipitation, • To determine the stability of the precipitates from neutralisation of the biooxidation solution according to multiple extraction method adopted by the EPA (Environmental Protection Agency) of the USA.

Important Properties of Bacterial Culture:
The mesophilic Bacterial Culture to be imported is supplied by M/S GEOBIOTICS LLC through an independent collaborative Research Lab. M/S SGS-LAKEFIELD. It is classified as a Class 1 Agent by US Department of Health Education and Welfare, Public Health Service. A Class 1 Agent is defined by them as one of no recognized hazard under ordinary conditions of handling. The Bacterial Culture to be imported is non-pathogenic, aerobic, autotrophic and chemosynthetic. These microorganisms naturally occur throughout the world and they are not Genetically Modified or produced by Recombinant

Decontamination, Disposal Mechanism, Risk Assessment:
The shipment will be contained in sealed flasks at ambient temperature at pH 1.3-2.2 within packaging appropriate for transport of a very dilute acid. The usual International Regulations apply for the transport of acids by air. This mesophilic bacterial culture is non-pathogenic and their existence depends on such specific conditions of acidity and oxygen supply that it can be disposed off as any acidic solution after neutralization to boost up the pH. As soon as the pH gets more than 3, the culture decline and become part of the general bacterial background. The shipment will be in the form of slurry of concentrate and acid at pH 1.3-2.2, at which level the culture will be in a hibernating state.

Quantity of Bacterial Culture to be accessed:
GEOBIOTICS LLC mesophile cultures have a useful shelf life of around 3 months given that they are stored at around room temperature, after which time the buildup of an inoculum from that culture becomes more difficult. Accordingly, and allowing for unforeseen procedural errors in the laboratory, it is requested for an allowance to import a fresh culture batch of 5 litres volume annually for 2 years (total 10 liters). The proposed collection (mesophile mixed bacterial culture) will be imported via Air/Sea from M/S SGS-LAKEFIELD (Johannesburg, South Africa).

TERI, NEW DELHI Background Appreciation
The dependence of human beings on biological diversity is evident in everyday life. Food, fiber, fuel, fodder, shelter, health and other needs of the growing world population are dependent on various components of biodiversity. It is also recognized that plant genetic resources for food and agriculture are a common concern of mankind and most countries depend on plant genetic resources originated elsewhere. Therefore, sustainable use of biological diversity at the national as well as international levels is of critical importance. For the same reason, access to and sharing of both genetic resources and technologies among nations is essential.
The Biological Diversity Act (BDA) was formulated after India became signatory to the Convention on Biological Diversity (CBD). Its objectives are 'to provide for conservation of biological diversity, sustainable use of its components and equitable sharing of the benefits arising out of the use of biological resources and for matters connected therewith or incidental thereto'.
These vital issues are faced with multiple challenges. It is all the more complex considering the involvement of a large number of stakeholders e.g. researchers, industries, foreigners and the local people. In view of this, formation of an expert committee on Access and Benefit Sharing and Material Transfer Agreement (MTA) by National Biodiversity Authority (NA) of India is a step in the right direction. This will help in formulating detailed guidelines for equitable sharing of benefits and prior informed consent, keeping in view the interests of the country, particularly the local people.

About TERI (The Energy and Resources Institute)
The Energy and Resource institute (TERI) is an autonomous, not for profit research institute established in 1974. As a unique developing country institution, TERI is committed to the goal of sustainable development. Simultaneous maintenance of ecological balance and sustainable levels of natural resources is one of its major visions. A booklet detailing the organizational profile of TERI is enclosed.

The Forestry and Biodiversity Group
The Forestry and Biodiversity Group of TERI deals with diverse range of issues related to technical, policy and socio-economic aspects of India's forest resources, biodiversity conservation and rural development. The group is actively working to promote community participation in forest conservation through various institutional, training, capacity building programs, addressing gender issues, biodiversity research, management and access and benefit sharing and policy mechanisms. In addition, the group is involved in experimental research for afforestation in difficult sites including nursery development and silvicultural work.
Among the major focal areas are the impact of current policies and guidelines dealing with socio-economic and institutional aspects along with necessary inter-sectoral linkages for sustainable utilisation and conservation of biological resources and the role of community-based efforts. The group, thus, endeavours to facilitate the creation and development of models, systems and concepts for conservation and sustainable utilisation of our natural resources. Besides, we have also put considerable effort into documenting our research findings on the key issues involved in this sector through publications in the form of manuals, books, popular articles, research articles in national and international journals and awareness generation programs.
Forestry and Biodiversity Group has a multi-disciplinary, well-qualified and experienced team of professionals with backgrounds in biodiversity conservation, community resource development, gender issues, environmental and forest management, socio-economics, and agro forestry to name a few. Teams are drawn up in accordance with the specific needs of the projects, representing flexibility of approach and optimizing use of its diverse expertise. The Institute's strength also lies in its ability to effectively translate research results into tangible outcomes, which influence policies and institutional arrangements.

Role of TERI in the proposed project
As defined in Terms of Reference (ToR), TERI will assist the Expert Committee on Access and Benefit Sharing (ABS) and Material Transfer Agreement (MAT) on the following aspects: • Inventory of Material Transfer Agreements (MTA) in various government departments and organisations.
• Develop guidelines for patents in the light of benefit sharing arising out of biological diversity as per sub-section 2 of Section 6 of the Biological Diversity Act 2002.
• Develop guidelines, procedures and protocols for access to parts /whole of Flora, Fauna, Microorganisms and Genetic Material for new collections for research and/or commercial utilization.
• Develop guidelines for imposing terms and conditions for ensuring equitable sharing of benefits arising out of the use of accessed biological material and associated knowledge in mutual agreement between the person applying of approval and the Authority in consultation with the Biodiversity Management Committee (BMC) taking into consideration of defined parameters of access, the extent of use, the sustainability aspect, impact and expected outcome levels including measures ensuring conservation and sustainable use of biological diversity.
• Develop guidelines for Prior Informed Consent (PIC) for researchers, industries, foreigners, State Biodiversity Boards, Biodiversity Management Committee (BMC) incorporating benefit-sharing clause.
TERI would undertake the assignment under the supervision and overall guidance of the expert committee.

Project Team and its experience
TERI would depute an expert for assisting the Expert Committee. Deputation of Dr C S Silori, an expert in the field of Biodiversity Conservation is proposed for the purpose. Depending upon the need, other experts would be involved to complete the assignment. Dr Silori's CV is annexed.

Project Remuneration
TERI will take this assignment at organisational level. For this, payment of a lumpsum amount may be considered as the remuneration. As the deputed professional of TERI would have to undertake journeys to Chennai for the committee meetings and on other occasions whenever needed, travel costs besides the boarding and lodging expenses would need to be reimbursed.
It is proposed that a lumpsum amount of Rs.2.50 lakhs may be considered as professional fee to TERI. The mode of travel could be by train from Bangalore and by air from Delhi. The boarding and lodging reimbursements could be as per TERI's entitlements.
TERI agrees to the ToR defined n the website of NBA for the said consultancy work.The duration would be 90 days or as extended by the NBA.

The authority is requested to approve
The authority approved the proposal and mentioned that the TOR should include the duration of 90 days and a lump sum amount of Rs 2.50 lakhs. Dr. S.Kanniyan, Chairman, NBA welcomed the members. In his welcome address the Chairman underscored in detail about the importance of Agro biodiversity and the need for effective functioning of National Biodiversity Authority to protect the Agricultural Biodiversity in India. He observed that implementation of the biodiversity Act 2002 is the need of the hour to protect our Agricultural Biodiversity from foreigners, who continue the exploit this wealth without giving due credit to India. He has mentioned the provisions in section 3,4 and 5 ad also indicated that the prior approval is needed from NBA for IPR. He requested the members to actively participate and make suggestions to frame guidelines for transfer and exchange of biological resources and information on traditional knowledge under collaborative research projects. The Chairman, NBA has indicated the guidelines for collaborative research prepared through a Committee of experts headed by Dr SP Tiwari and discussed in several meetings and interactive workshops and improved the draft significantly and the draft guidelines are in final shape for further improvements and suggestions by the members of the Advisory committee.

ACTION
Dr E.A.Siddiq former DDG crops ICAR, and Chairman of the committee pointed out that there were already some rules and guidelines are available in the ICAR for exchange of bioresources. Due to recent development at global level, new rules and regulations need to be framed especially for projects involving exchange for collaborative research. He also requested to discuss in detail how the benefit sharing mechanism of our germplasm would be shared by the parties in collaborative projects. He emphasized the importance of monitoring mechanism for third party transfers.
Dr. Kalapana Sastry, Principal Scientist, NAARM, Hyderabad presented the draft "Guideliness for transfer/exchange of biological resources and information under collaborative research projects and bilateral agreements/MoU for research involving foreign individuals/agencies. She has mentioned the provisions in Section 3,4 and 5 and also indicated that the prior approval is needed from NBA for IPR. During the presentation minor details were looked at and the members suggested to incorporate the details and improved the draft guidelines. At the end of the presentation there was a detailed discussion on different issues of the guidelines and Chairman and the members have approved the guidelines for further action by NBA.
The following important topics were considered for discussion in the next meeting.

Recommendations of the Committee:
1. The Second meeting of the EC will be held at the National Chemical Laboratory, Pune, on the 3 rd February 2006.
2. The Expert Consultant, Ms. Tijitha Anand to take up the task of compiling an exhaustive list of all institutes and organisations that has databases on biodiversity, making use of the format given on the NCBI website.
3. Dr. Vishwas Chavan and Dr. Chinmaya Rathore to take up the task of forming a "Collaborative framework for setting up of the National Biodiversity Information System" that will be discussed in the next meeting of the Expert Committee.
4. The importance to recognize the knowledge providers in order to sustain Biodiversity Act and Rules.
5. The need for a legal framework for recognition of rights in the area of traditional knowledge and biodiversity.

HONORARIUM FOR NBA BULLETIN
NBA is publishing a NBA bulletin regularly. For this purpose articles are invited on selected topics and revised for publication and the authors to be paid an honorarium of Rs 5000/= (Rs Five thousands only) which includes honorarium and secretarial assistance. In case of more than one authors of the NBA bulletin the amount will be shared equally.

The Authority is requested to approve
The Authority approved the payment of Honorarium and secretarial assistance of Rs 5000/= (Rs Five thousands only) to the authors for the preparation of NBA Bulletin.

Type of Bioresource
: To conduct a qualitative survey of selected lesser known insect taxa of the Western Ghats of India.

Reference No 8/2/218/2003-NBA(S) Name of the Applicant: Mr Priyadarshan Dharma Rajan
The taxonomic identification should be carried out in India with the help of Zoological Survey of India and other agencies. If so needed, the details including images be sent electronically. This is an era of virtual connectivity and the taxonomic identification alone does not justify transfer of insects.
After classification the specimen should be deposited in designated repository.
There are other small discrepancies which may be noted. ICAR museum for insect deposits does not exist. The PDBC and IARI have need-based repository services of insects of agricultural importance. The PI should be aware of existing mechanisms, technical/technological resource support available in our country for insect collection and identification.
Views of other members be also sought since this issue has not been put to the committee.

Sd. xxxxxx Dr S Prakash Tiwari Director, NAARM Hydrabad Chairman of the committee The Authority is requested to approve
The Authority did not approve the application for sending the insects collected for identification in foreign museums as mentioned in the application and informed that the identification of insects collected by the applicant is to be made with the Indian organization such as Zoological Survey of India.

I. Background
Taking

II. Scope and Purpose
Under the new regulatory mechanism in force in India, the means, mechanisms

IV. Title
The Guidelines may be called "Guidelines for Transfer/Exchange of Biological

Resources or Information Under Collaborative Research Projects and Bilateral
Agreements / MoU for Research Involving Foreign Individuals/Agencies".
These are referred to as "The guidelines" in the following text.

V. The Guidelines
1. The guidelines are applicable to agro-biodiversity components meaning "biological diversity of agriculture related species and their wild relatives" as explained in Section 13 (1)  6. The guidelines cover transfer/exchange of biological resources pertaining to agro biodiversity.
7. The collaborative research project, in no way, should jeopardize the stake of claims of national sovereignty on biological resources of India.
8. The aims, objectives, technical plan, output, outcome and impact of the collaborative project should be congruent with the relevant national/state policies and goals such as EXIM policy.
9. To cope with or avert the existing or potential calamity or to meet dire national or regional needs, the concerned department of Central Government of India may, on its own volition, send through the concerned authorized repository, the biological resource(s) for testing, screening, improvement or otherwise as deemed fit in the national interest in any collaborative research mode as considered appropriate.
10. The exemptions provided in the guidelines are not applicable to the collaborative research project merely and solely aiming towards exploration and collection of biological resources. The exploration and collection of biological resources, if considered a prerequisite of any collaborative research project, should be undertaken by the national repositories/bureaus only. The material so collected should be deposited in the concerned national repository/bureau and given an indigenous collection accession number. Thus collected and documented resource can, then, be used in the collaborative research project.
11. Any new taxon/breed/genetic stock/culture/strain/line discovered or developed through the project shall be notified to the concerned repositories/bureaus, and the voucher specimen be deposited with them. 14. The transfer/exchange of biological resources shall be for research purpose only. 15. The quantity of material to be transferred / exchanged shall be limited to the needed experimental quantity of the biological resource(s) as specified by the concerned repositories / bureaus on a case-by-case basis. 16. 18. The concerned department/repositories of biological resource(s), as applicable, will issue import permit and will carry out quarantine processing prior to the release of the material in India. Biological resource(s) transferred for research should be free from pests/pathogens of quarantine importance. While effecting the transfer/exchange of the biological resource(s), the necessary sanitation and phyto-sanitation measures and quarantine procedures as prescribed shall be strictly adhered to. These may include reports on case history of the biological resource(s) and risk analysis based on the 25. Research papers, books, bulletins, registered accessions, patents and outputs in other forms of intellectual property shall be appropriately shared between the collaborators. The mechanism of sharing and protecting/patenting the outputs should be explicitly spelt out in the project and approved by the competent authority.
26. The list of biological resource(s) to be transferred /exchanged under the project shall be sent to the National Biodiversity Authority for prior information.
27. Benefits eventually accruing from the use of biological resource(s) transferred/exchanged under the collaborative research projects would be assessed and the benefit sharing would be determined by the NBA as per provisions of the Section 21 of the BD Act, 2002.

28.
Transfer/exchange of transgenic material would be governed by the provisions of Environmental (Protection) Act 1986 and its subordinate legislation governing rules on Manufacture, Use, Import, Export

32.2
The micro-organisms, which could be used for biological warfare/high risk group/sensitive for bio security shall not be exported or imported.
32.3 All requests made for the permission to exchange/export/import microbial germplasm samples must be accompanied with the detailed information on aspects such as scientific name, markers, identification and detection techniques, distribution and habitat, genetic stability and related aspects. The Authority is requested to appove

Recommendations of the Committee:
1. The Second meeting of the EC will be held at the National Chemical Laboratory, Pune, on the 3 rd February 2006.
2. The Member Secretary, Ms. Tijitha Anand to take up the task of compiling an exhaustive list of all institutes and organisations that have databases on biodiversity, making use of the format given on the NCBI website.
3. Dr. Vishwas Chavan and Dr. Chinmaya Rathore to take up the task of forming a "Collaborative framework for setting up of the National Biodiversity Information System" that will be discussed in the next meeting of the Expert Committee.
4. The importance to recognize the knowledge providers in order to sustain Biodiversity Act and Rules.

5.
The need for a legal framework for recognition of rights in the area of traditional knowledge and biodiversity. He elaborated on the importance of collaborative research in the increase of our knowledge and how in many ministries guidelines are not in place. He said that the full day deliberations would be useful to NBA to fulfill its agenda and duties and also that the NBA would assist the committee in every way possible in order to ensure that its task is achieved. He explained the process used by the ICAR to develop their guidelines by a special committee of experts and how every scientist was given an opportunity to express his views through many interactive sessions with four National bureaus of the ICAR a group of experts of ICAR. He explained that a similar procedure would help in getting more diverse views on collaborative research and the committee would come out with a clear document. He also invited the members to suggest names of experts who would be able to contribute towards the development of a policy guideline for the entire country. He then requested the committee Chairman to conduct the procedings OPENING REMARKS: Dr. B. S. Dhillon, Chairman, EC on Collaborative Research Dr. B. S. Dhillon commented on the difficult task that the committee has to undertake and welcomed all suggestions by the committee. He explained the situation in ICAR which deals with domesticated diversity with the help of the four National Bureaus and said that this committee had a greater challenges that it has to address the entire diversity represented in India. He also said that the draft guidelines developed by the ICAR are for germplasm exchange only while this committee has a broader and wider scope. He said that this committee needed to develop a common guideline which was applicable to all collaborative projects whether run through Government departments or private organisations.

Discuss Section 5 of the BD Act 2002 and any other relevant section for this committee.
The committee discussed the section 3, 4 and 5 of the BD Act 2002. They deliberated on the definition of the term body corporate and types of private organisations. It was decided that any company whether Indian or foreign which had a share capital from foreign country would need to get the approval from NBA to have any access to biological diversity.
The committee also deliberated on the "such institutions" of Section 5 and decided that this applied to all Government Departments and institutions.
Prof. Kannaiyan explained how third party transfers which are done without the knowledge of the Indian government is a great loss to the people of our country. Hence all such transfers based on India's biodiversity should be monitored and need stringent regulations.
There was a general discussion on who should be involved in the preparation of the guidelines. Dr. Venkatraman indicated that all the relevant ministries that deal in Biodiversity should have guidelines in place and these ministries should be listed and involved in the preparation of the guidelines. Else they should be requested to prepare independent guidelines for the activities of their ministries and the NBA would facilitate in technical matters and in any other way in necessary. Dr. Lavekar proposed that his Department of Ayush would like to develop such guidelines with the technical help from NBA.
Dr. T. C. Narendran was concerned that at present the repositories of germplasm/ specimen are not favourable to loan out of specimen for studies to outstation universities and institutes, while the repositories abroad are more than willing to share their information and specimens. He said that this needs to be rectified.
Dr. P. C. Ramakrishnan explained the importance of the traditional knowledge value systems in villages and how new technologies are eroding these value systems. He said that these guidelines should ensure that the local people's knowledge is safeguarded. He also reiterated that all local communities should be aware of the BD Act and the guidelines.

Discuss the documents available and the ICAR Draft Guideline on Germplasm Exchange
The meeting material contained a few guidelines/ agreements developed by an NGO, two government departments and an International Research Agency (Appendix I). These documents were reviewed in minute details so as to cull out the relevant sections and principles and use them for the Indian guidelines.
Dr B.S.Dhillon asked for the ICAR draft guidelines (Appendix II) on germplasm exchange and suggested that we could use it as a template to build upon. The committee then deliberated on all the points of the guidelines and made changes to suit the present broader and more complex nature of the overall guidelines.
3. Discuss the "terms of reference" given to this committee to find out ways in which to meet the terms. --The way forward.
The terms of reference given to the committee were discussed and seen whether in the present meeting they were met and what more needs to be done so that the committee may fulfill these terms.
Term of reference:

Section 5 of BD Act viz; bilateral or multilateral research approved by the Government of India (Note: Whether there is policy Guideline by the Government of India? Whether the Biodiversity Act has incorporated into already existing guidelines? Whether there is a need to prepare a new set of guidelines?)
It was decided that the NBA should approach all the relevant ministries and obtain the present guidelines under which collaborative projects are approved. The NBA also to find out the types of collaboration underway in India that are related to biodiversity.

• Develop guidelines in accordance with Section 5 of BD Act, for collaborative research amongst organisations, universities, departments etc involving foreign institutions (In view of the increased focus by outside agencies/organisation on certain groups of organisms such as salt tolerant varieties and insects, the committee may consider tightening of norms for collaborative research).
At present the guidelines appended in II address the above concern. The committee discussed whether there was a need to differentiate in the collaborating institutes/bodies. It was decided that the policy guidelines developed by this committee will apply to all bodies/institutes that undertake collaborative projects ie; it shall apply to all.

• Develop guidelines in accordance with Section 5 of BD Act, for accredited or approved bodies and industry; between industries and research organizations supported by the Government; industries and research organizations; between academic institutions within India and abroad.
It was decided that since the guidelines would apply to all collaborating institutes, there was no need to make distinction between the natures of the collaborators. But the committee needs to ensure that third party transfers and benefit sharing issues are adequately addressed.

• Develop guidelines in accordance with Section 5 of BD Act, for non collaborative research (collections) under the following three categories viz; flora, fauna and microorganisms of soils. sediments and genetic material from dead organisms. • Develop guidelines for sharing of data and ongoing research in accordance to the Act.
The committee decided that the above two terms were not within their purview since they were outside of the collaborative research. Dr. Venkatraman explained the different committees that are functioning and are proposed to be formed in the forthcoming NBA meeting. He also explained that some of the other committee will address other issues. This committee can send in their recommendations to the other committees in a transparent way by sharing the view with other committee members. He said that at present the NBA does not have an implementing body and the forest department of the State Govt. may be used as the enforcement agencies for the NBA as earlier suggested by a member of the Authority Mr A J Kurian in the third meeting.
He also explained that the term "from dead organisms" was added to emphasize that dead parts harbour a lot of microbial diversity and should not be treated as inanimate objects.

Discussions on any other matters:
A few names were recommended by the experts to be included for organizing an interactive sessions and in the next meeting of the expert committee as needed.

Recommendations
The committee recommended the following 1. To merge the salient features of the documents discussed in the meeting and the ICAR document in order to prepare the first draft of the guidelines.
2. To organize interactive sessions with relevant scientists and policy makers, once the first draft of the guidelines are approved by this committee.
3. To send communications to the relevant ministries on the importance of making their own guidelines and defining their priority areas for undertaking collaborative research. 4. To communicate to them the ways in which NBA will support their efforts.
5. To gather information on the ongoing collaborations relating to research in biological diversity (All Ministries, All Universities, UGC Chairman, DG ICAR, DG CSIR, Secretary Animal Husbandary are to be addressed).
Concluding Remarks: Dr. B. S. Dhillon, Chairman, EC on Collaborative Research The Chairman thanked all the members for their cooperation and inputs to the deliberations and suggested that the next meeting should be on any Saturday in April.

A. CONTEXT
In recent years there have been immense developments in the biological sciences. Globalisation has led to further competition amongst nations. This had made collaborative research even more relevant in today's time. Efforts to increase and to communicate knowledge are at the heart of collaborative academic endeavours. Quite often these collaborative endeavours will result in the creation of IP which will have rights conferred by statute and common law in India and which may be eligible for rights in other countries and under international treaties. Within the Indian Scientific community it is important to ensure that such rights are properly conferred on all those who are responsible for the development of the IP, while at the same time encouraging the openness and free exchange of ideas that are essential to successful scholarship. This policy requires the contribution of all parties to be appropriately recognized.
India has a responsibility towards its people and to protect the biological resources which the people depend upon are not harmed. India has to be alert and responsive to the changing political legal and market environments to ensure the above. The NBA is committed to excellence in India's research and academic programs and it recognizes that the country's strengths can be enhanced by collaborative relationships with international partners, including governments, academic institutions, and other organizations. Such collaborative relationships should strengthen and complement India's scientific priorities and mission. The NBA encourages researchers to share information and work in collaboration with others, where this is likely to advance the state of knowledge. Taking  Thus, a comprehensive strategy and general guidelines for collaborative projects needs to be formulated. The purpose of this policy is to set out the process by which proposed collaborative research partnerships with external institutions will be assessed and approved by the NBA. In considering a research partnership with other academic institutions, the NBA's responsibility and a paramount consideration is to protect the quality of India's research, academic programs and reputation, and also to assess and address any academic, legal, safety, and financial risks to India's environment and biological diversity, people and scientists. However, a critical need that cannot be imposed by this policy/guideline is the requirement for all parties to discuss and negotiate issues with professionalism and in good faith. B. PREAMBLE 1. The National Biodiversity Authority is a Statutory Body established by the National Government of India as per the section 8(1) of the National Biological Diversity Act 2002. The mission of the NBA is: a. To encourage and support conservation and sustainable use of biological diversity and equitable sharing of benefits arising out of the utilisation of the biological resources. b. To respect and protect the knowledge of the local people relating to the use of biological diversity. c. To regulate by issue of guidelines for access to biological resources and for fair and equitable benefit sharing and for collaborative research. 2. The National Biodiversity Authority's policy/guideline on Collaborative Research has been developed to fulfill India's objective in ratifying CBD by providing: a. clear objectives and principles on conduct of collaborative research b. guidelines on which agencies in India are designated to approve collaborative projects c. guidelines and mechanisms/procedures to obtain approval for collaborative projects. 3. It is the responsibility of the NBA to ensure that this policy/guidelines are distributed to all universities and research institutions so that all researchers are made aware on this policy and surrounding issues.

C. GUIDING PRINCIPLES
The National Biodiversity Authority abides by all relevant national and international laws concerned with management of biological diversity. The National Biodiversity Authority recognizes India's commitment to the treaties India is signatory to, that deal with the management of Biological diversity. The National Biodiversity Authority endorses the Convention on Biological Diversity. The National Biodiversity Authority shall adopt procedures and employ practices to safeguard India's Biological Diversity and related knowledge.

D. DEFINITIONS OF TERMS AS USED IN THE GUIDELINES (from the Act)
m) "Agrobiodiversity" means biological diversity of agriculture related species and their relatives including plants, animals, fish and micro organisms n) "benefit claimers" means the conservers of biological resources, their byproducts, creators and holders of knowledge and information relating to the use of such biological resources, innovations and practices associated with such use and application; o) "biological diversity" means the variability among living organisms from all sources and the ecological complexes of which they are part, and includes diversity within species or between species and of eco systems; p) "biological resources" means plants, animals and micro organisms or parts thereof, their genetic material and by products (excluding value added products) with actual or potential use or value, but does not include human genetic material; q) "bio survey and bio utilization" means survey or collection of species, subspecies, genes, components and extracts of biological resource for any purpose and includes characterization, inventorisation and bioassay; r) "commercial utilization" means end uses of biological resources for commercial utilization such as drugs, industrial enzymes, food flavours, fragrance, cosmetics, emulsifiers, oleoresins, colours, extracts and genes used for improving crops and livestock through genetic intervention, but does not include conventional breeding or traditional practices in use in any agriculture, horticulture, poultry, dairy farming, animal husbandry or bee keeping; s) "fair and equitable benefit sharing" means sharing of benefits as determined by the National Biodiversity Authority under section 2 1; t) "National Biodiversity Authority" means the National Biodiversity Authority established under section 8; u) "research" means study or systematic investigation of any biological resource or technological application, that uses biological systems, living organisms or derivatives thereof to make or modify products or processes for any use; v) "State Biodiversity Board" means the State Biodiversity Board established under section 22; w) "sustainable use" means the use of components of biological diversity in such manner and at such rate that does not lead to the long term decline of the biological diversity thereby maintaining its potential to meet the needs and aspirations of present and future generations; x) "value added products" means products which may contain portions or extracts of plants and animals in unrecognizable and physically inseparable form. 2. The collaborating parties shall immediately report to the NBA any difficulties it encounters in complying with the guidelines/agreements when the project is in progress.

XII. Closing Statements
This policy is effective from _______________ and will remain in force until cancelled in writing by the National Biodiversity Authority.
The National Biodiversity Authority shall regularly review this policy statement and its implementation in order to ensure that its mission is achieved.

The Authority is requested to approve
The members of the authority felt that the draft guidelines need through improvements and after further interactions with experts and with a legal touch by the Legal Consultant of NBA this may be brought to the authority for approval.

6.MEETING ON FINALISATION OF AGREEMENTS ON 17 TH Jan 2006
Members Present:

APPROVAL AGREEMENT FOR ACCESS TO BIOLOGICAL RESOURCES (Commercial Purposes)
This Agreement is entered into as of the …………. day of ……………., year…….
And …………… (Hereinafter referred to as "the Manufacturer/Company/Institute/ Individual") Hereinafter, the NBA and the Manufacturer/Company/Institute/ Individual shall collectively be referred to as "the Parties" and individually as "Party". Manufacturer is a Company ………….and having business interests in the manufacturing of products which requires certain biological resources as a raw materials.
Manufacturer has made an application in Form I, under Rule 14 of the Biological Diversity Rules 2004 to seek approval from the NBA to access the biological resources for the purposes of Commercial Utilisation of the same.
The Parties hereto agree as follows:

Definitions
In this Agreement: Act means the Biological Diversity Act 2003 (Act 18 of 2003) and includes the Rules/Regulations/guidelines/notifications made under it.
Biological Resources: means biological resources as defined in the Act, (As defined in Section 2 c) which the Manufacturer desires to access for the purposes of Commercial Utilisation and which is more fully described in Schedule A to this Agreement.
Commercial Utilisation means any use as described in the Act and limited to the actual use as described in Schedule B to this Agreement.
[Additions to this clause to be made in accordance with the needs on a case to case basis]

Interpretations
Unless expressed to the contrary, in this Agreement: (a) words in the singular include the plural and vice versa; (b) any gender includes the other genders; (c) if a word or phrase is defined, its other grammatical forms have corresponding meanings; (d) a reference to: (i) a person includes a partnership, joint venture, unincorporated association, corporation and a government or statutory body or authority; (ii) any legislation or subordinate legislation includes any corresponding later legislation or subordinate legislation; (iii) an obligation includes a warranty or representation and a reference to a failure to comply with an obligation includes a breach of warranty or representation; (iv) writing includes any mode of representing or reproducing words in tangible and permanently visible form, and includes fax transmission; and (v) this Agreement includes all schedules and annexures to it; (g) if the date on or by which any act must be done under this document is not a Business Day, the act must be done on or by the next Business Day.
(h) All headings in this Agreement have been inserted as a matter of convenience and for reference only and in no way define, limit, enlarge, modify the scope or meaning of the Agreement or any of its provisions.

Grant of Approval
3.1 The APPLICANT requests for approval and the NBA hereby grants the approval to access the Biological Resources for the purposes of Commercial Utilisation subject to the terms and conditions set forth in this Agreement.
3.2 Any activities/use involving the Biological Resources that are not expressly authorized by the provisions of this Agreement and any annexures hereto shall be deemed to be expressly prohibited.

3.3
The APPLICANT hereby agrees that this Agreement shall not in any way constitute or be presumed to constitute a partnership, joint venture or joint enterprise in any way or for any purpose between the Parties hereto or make them in any way liable as partners of or as agents for one another.

No
Party has the authority to act for or to assume any obligation or responsibility on behalf of the other Party and the relationship between the Parties is that of a person and a statutory authority competent to approve certain actions under the Act.

Assignment
4.1 Without the prior written consent (which consent shall entirely be the sole discretion of the NBA) of the NBA in each instance, neither this Agreement nor the rights granted hereunder shall be transferred or assigned in whole or in part by the Manufacturer to any person whether voluntarily or involuntarily, by operation of law or otherwise. Failure of the Manufacturer to obtain the prior written consent of the NBA to any such transfer or assignment shall be deemed to be a material breach of this Agreement and result in the immediate termination of this Agreement, without notice.

This
Agreement is strictly personal and is granted to the Manufacturer (as per the description detailed in Schedule C) and this Agreement will be treated as terminated in the event of any substantial changes in the management or shareholding of the Manufacturer including the changes brought by a merger, demerger or any other kind of corporate restructuring. Any such substantial changes shall deem the Manufacturer as a new entity.
4.3 Any such substantial changes as mentioned in clause 4.2, which transforms the Manufacturer into a deemed new entity, shall have to make a fresh application as required under the Act to access the Biological Resources permitted under this Agreement. For the removal of doubts, it is made clear that any activity undertaken by the deemed new entity under the approvals granted under this Agreement will be deemed illegal.

The Manufacturer shall submit a written undertaking before accessing any Biological
Resources to the effect that the Biological Resources can be used sustainably (as defined in the Act Section 2(o)). 7.4 In the event of large amounts of raw material being required for production, the Manufacturer/User will investigate the mass propagation (cultivation) of the material in India. Consideration will be given to sustainable harvest of the material while conserving the biological diversity of the region, and involvement of the local population in the planning and implementation stages, so as to generate employment to the local people.

8.4
The audit by such authorized person shall be at the expense of NBA, except that if such audit shows an underreporting or underpayment in excess of five percent (5%) for any twelve (12) month period, then Manufacturer/such other person shall pay the cost of such examination as well as any additional sum that would have been payable to NBA had the Manufacturer/such other person reported correctly, plus interest on said sum at the rate of three per cent (3%) more than the then prevailing rate of Interest in a nationalized bank per month from the date of the incorrect reporting.

9.1
The NBA makes no warranties of any kind, express or implied, under domestic or international laws as to the safety of the Biological Resources, nor as to the accuracy or correctness of any passport data or any other data provided by the NBA or any other person or agency. The NBA does not make any warranties as to quality, viability or purity (genetic or otherwise) of the Biological Resources.
9.2 The Manufacturer shall be solely responsible for any claims by third parties arising from the Manufacturer's acts or omissions in the course of performing this Agreement and under no circumstances shall the NBA be held responsible for any such claims by third parties.
9.3 The Manufacturer indemnifies and save harmless NBA and its employees from and against all claims, demands, losses, damages, costs (including attorney fees), actions, suits or other proceedings, all in any manner based upon, arising out of, related to, occasioned by or attributable to, any acts or conduct of the Manufacturer, its employees or agents, (whether by reason of negligence or otherwise) in the performance by the Manufacturer of the provisions of this Agreement or any activity undertaken or purported to be undertaken under the authority or pursuant to the terms of this Agreement.

Notice
11.1 Wherever in this Agreement, it is required or permitted that a communication, notice or demand be given or served by either Party to or on the other Party, such communication, notice or demand will be in writing and will be validly given or sufficiently communicated if forwarded by Registered mail acknowledgement due, email, telegram, telex or facsimile as follows: The addresses for delivery are: To the NBA: The (c) if sent by certified mail, four (4) days after the mailing thereof, provided that if there is a postal strike or other disruption such notice will be delivered by hand or electronic transmission.

11.3
The Parties may change their respective addresses for delivery by delivering notice of change as provided in this paragraph. 12.1.2 All aspects of such negotiation, except the fact of its occurrence, will be privileged and no Party shall be allowed to rely on the records of such negotiation before any arbitration or proceedings in any court.

Arbitration
12.2.1 If the Dispute is not resolved by such good faith negotiation within the period mentioned, the Parties agree to settle the Dispute through arbitration conducted by the sole arbitrator appointed by the NBA. The arbitration shall be governed by the Arbitration and Conciliation Act, 1996. The place of arbitration shall be Chennai, India. The language to be used in the arbitration proceedings shall be in English or as mutually agreed between Parties.

12.2.2
The parties hereto agree that the award and determination of the arbitrator shall be final and binding on both parties hereto.

12.2.3
During the progress of arbitration, the Parties hereto shall continue to perform their obligations under this Agreement.

Attorney Fees
The Parties hereto agree that in the event that this Agreement becomes subject to litigation (either in Courts or before Arbitration) between the Parties hereto, the prevailing Party shall be entitled to an award of attorney's fees, costs, and interest at the rate of 15% from the other Party. The interest shall be calculated from the date of notice of the Dispute given in accordance with the terms of this Agreement.

Governing Law and Jurisdiction
This Agreement is governed by and is to be construed in accordance with the laws of the Republic of India without regard for conflicts of laws principles. The Parties irrevocably and unconditionally submits to the exclusive jurisdiction of the courts in Chennai, India and any courts which have jurisdiction to hear appeals from any of those courts and waives any right to object to any proceedings being brought in those courts.

Waiver
The Waiver by NBA, of any breach of any terms of this Agreement made by the Manufacturer shall not prevent the subsequent enforcement of that term and shall not be deemed a waiver of any subsequent breach.

Severability
If any part of this Agreement is declared or held invalid by a court for any reason, the invalidity of that part will not affect the validity of the remainder which will continue in full force and effect and be construed as if the Agreement had been executed without the invalid portion.

Modification
No amendment or modification of this Agreement shall be valid or binding upon the Parties, unless agreed upon by both Parties, made in writing, and signed on behalf of each of the Parties by their duly and legally authorized signatories.

Entire Agreement
17.1 This Agreement constitutes the entire understanding between the parties as to the subject matter of this Agreement. This Agreement sets forth all representations forming part of or in any way affecting or relating to the subject matter of this Agreement.
17.2 The Parties acknowledge that there are no representations either oral or written, as regards the subject matter of this Agreement, between the NBA and the Manufacturer other than those expressly set out in this Agreement. All previous negotiations, understandings, representations, warranties, memoranda or commitments concerning the subject matter of this Agreement are merged in and superseded by this document and are of no effect.
For the removal of doubts, 'subject matter of this Agreement' is the transfer of results of research on any biological resource obtained from India.

Representations
18.1 Either Party represent to each other Party that it has the legal right and power to enter into this Agreement and to perform its obligations under the terms of this Agreement and the execution, delivery and performance of this Agreement by it has been duly and validly authorized by all necessary corporate action or Government action on its part.
18.2 The Parties further represent that this Agreement is valid and binding agreement of it, enforceable in accordance with its terms and the execution and performance of this Agreement by it does not, and other transactions contemplated by this Agreement do not, violate or conflict with or result in a breach of or constitute a default under its constitution or laws. This Agreement has been executed in Duplicate. Each of which shall be deemed to be an original, but all of which together shall constitute one and the same instrument.
IN WITNESS WHEREOF this Agreement has been executed by duly authorized representatives of the Parties on the day and the year first mentioned For National Biodiversity Authority: For the Manufacturer:

APPROVAL AGREEMENT FOR ACCESS TO BIOLOGICAL RESOURCES (Research/Bio-survey)
This Agreement is entered into as of the …………. day of ……………., 2005
Hereinafter, the NBA and the shall collectively be referred to as "the Parties" and individually as "Party".

WHEREAS:
NBA has been established by the Government of India under the powers granted to it by section 8 of the Biological Diversity Act 2002 (Act 18 of 2003). Under the said Act, NBA is the authority to permit access to any biological resources found within the territory of India.
Researcher has made an application in Form I, under Rule 14 of the Biological Diversity Rules 2004 to seek approval from the NBA for access to the Biological Resources for the purpose of Research/Bio-survey.
The Parties hereto agree as follows: 1. Definitions: In this Agreement: (h) All headings in this Agreement have been inserted as a matter of convenience and for reference only and in no way define, limit, enlarge, modify the scope or meaning of the Agreement or any of its provisions.

Grant of Approval
3.1 The Researcher requests for approval and the NBA hereby grants the approval to access the Biological Resources for the purposes of Research subject to the terms and conditions set forth in this Agreement.
3.2 Any activities involving the Biological resources that are not expressly authorized by the provisions of this Agreement and any annexures hereto shall be deemed to be expressly prohibited.

The
Researcher hereby agrees that this Agreement shall not in any way constitute or be presumed to constitute a partnership, joint venture or joint enterprise in any way or for any purpose between the Parties hereto or make them in any way liable as partners of or as agents for one another.

No
Party has the authority to act for or to assume any obligation or responsibility on behalf of the other Party and the relationship between the Parties is that of a person and a statutory authority competent to approve certain actions under the Act.

Assignment
4.1 Without the prior written consent (which consent shall entirely be the sole discretion of the NBA) of the NBA in each instance, neither this Agreement nor the rights granted hereunder shall be transferred or assigned in whole or in part by the to any person whether voluntarily or involuntarily, by operation of law or otherwise.

This
Agreement is strictly personal and is granted to the Researcher (as per the description detailed in Schedule C) and this Agreement will be treated as terminated in the event of any substantial changes in the management or shareholding of the including the changes brought by a merger, demerger or any other kind of corporate restructuring. Any such substantial changes shall deem the Researcher as a new entity.
4.3 Any such substantial changes as mentioned in clause 4.2, which transforms the Researcher into a deemed new entity, shall have to make a fresh application as required under the Act to transfer the Lead as permitted under this Agreement. For the removal of doubts, it is made clear that any activity undertaken by the deemed new entity under the approvals granted under this Agreement will be deemed illegal.

The Researcher shall have access only to …….. (quantity) of Biological
Resources and undertakes to extract the same in accordance with the directions given by the NBA (this may be delegated to SBB or BMC). The Researcher undertakes to make a statement in writing that none of the activities related to access to Biological Resources or the access itself will adversely affect the ecosystem or the environment.

5.2
The Researcher shall designate any person who shall be responsible for the safe custody of the Biological Resources. The Researcher undertakes that it shall not allow any persons other than its employees and agents under its direct control and supervision to have access to the Biological Resources. The Researcher shall obtain any other authorizations or permits which may be required under any other law in force and this approval is without prejudice to any other such authorizations or permits that may be required to legally carry out the activities under this Agreement. Failure to do so shall be a material breach of this Agreement.

5.4
The Researcher undertakes to submit half yearly reports on the progress of the Research to the NBA. The Researcher shall collaborate with an Indian research Institution/Universities and shall transfer knowledge, expertise and technology developed during the Research to that Indian entity subject to mutually acceptable guarantees for the protection of intellectual property associated with such technology. The Researcher shall deposit the voucher specimen/Type specimen in the designated repositories of India in culture collection in accordance with the guidelines/directions given by NBA.

No Transfer of Biological Resources or Associated Knowledge
6.1 The Researcher shall not distribute, transfer or part with the Biological Resources in any way without obtaining the prior written consent of the NBA under the provisions of the Act. Nothing contained in this Agreement shall be construed as an authorization from the NBA for the transfer of Biological Resources or any associated knowledge by the Researcher.
6.2 The Researcher undertakes to protect the Biological Materials at least as well as it protects its own valuable tangible personal property and shall take measures to protect the Biological Resources from any claims by third parties including creditors and trustees appointed by the court or other authorities in certain legal proceedings like bankruptcy, winding up etc. 7.3 The shall pay to the NBA a sum of ………Rupees as non refundable license fee upon execution of this Agreement.

8.1
The Researcher shall be solely responsible for any claims by third parties arising from the Researcher's acts or omissions in the course of performing this Agreement and under no circumstances shall the NBA be held responsible for any such claims by third parties.

The
Researcher shall indemnify and save harmless NBA and its employees from and against all claims, demands, losses, damages, costs (including attorney fees), actions, suits or other proceedings, all in any manner based upon, arising out of, related to, occasioned by or attributable to, any acts or conduct of the Researcher, its employees or agents, (whether by reason of negligence or otherwise) in the performance by the Researcher of the provisions of this Agreement or any activity undertaken or purported to be undertaken under the authority or pursuant to the terms of this Agreement.

Term and Termination
9.1 This Agreement, unless terminated as provided herein, shall remain in effect for a period of two years from the date on which the made its first access to the Biological Resources under this Agreement.
9.2 NBA may terminate this Agreement as follows: (a) If the Researcher does not make a payment due hereunder and fails to cure such nonpayment within forty-five (45) days after the date of notice in writing of such nonpayment by NBA.
(b) If the Researcher becomes insolvent or shall have a petition in bankruptcy, winding up filed for or against it. Such termination shall be effective immediately upon NBA giving written notice to the Researcher.
(c) Except as provided in subparagraphs (a) and (b) above, if the Researcher defaults in the performance of any obligations under this Agreement and the default has not been remedied within sixty (60) days after the date of notice in writing of such default by NBA.
9.3 The Researcher may terminate this Agreement by giving sixty (60) days advance written notice of termination to the NBA and paying a termination fee of…… Rupees. Upon termination, the Researcher shall submit a final Report of the entire research and results obtained from it to the NBA.
9.4 Upon termination of this Agreement, the Researcher shall cease all use of the Biological Resources and shall, upon request, return or destroy (at the option of NBA) all Biological Resources under its control or in its possession.
9.5 Clause 8.2 of this Agreement shall survive termination.

10.1
The NBA agree to treat as confidential any and all Confidential Information obtained from the marked as "CONFIDENTIAL" and to that end further agree that information disclosed pursuant to this Agreement relating to the Formulations, including efforts to commercialize the Formulations, shall be deemed Confidential Information.
10.2 Notwithstanding clause 10.1, Confidential Information may be disclosed to the extent required by any law or regulation of any governmental authority having jurisdiction over any of the Parties, with appropriate efforts made to maintain confidentiality.
10.3 Both Parties shall maintain Confidential Information in confidence, for as long as the confidential information does not fall within the Public Domain.
10.4 All information exchanged between the Parties under this Agreement or during the negotiation of this Agreement, marked 'CONFIDENTIAL' by the Party, is confidential and may not be disclosed to any person except to the Party's professional advisers on condition that they agree to be bound by the terms of this clause 10.5 Notwithstanding anything contained in this clause, the NBA shall not be restricted to make any disclosure of any confidential information, if in its reasonable opinion such disclosures become important to deal with any emergency conditions.

Force Majeure
The Researcher will not be liable for performance delays or for non-performance due to causes beyond its reasonable control.

Notice
12.1 Wherever in this Agreement, it is required or permitted that a communication, notice or demand be given or served by either Party to or on the other Party, such communication, notice or demand will be in writing and will be validly given or sufficiently communicated if forwarded by Registered mail acknowledgement due, email, telegram, telex or facsimile as follows: The addresses for delivery are: To the NBA: The (c) if sent by certified mail, four (4) days after the mailing thereof, provided that if there is a postal strike or other disruption such notice will be delivered by hand or electronic transmission.

12.3
The Parties may change their respective addresses for delivery by delivering notice of change as provided in this paragraph. 13.1.2 All aspects of such negotiation, except the fact of its occurrence, will be privileged and no Party shall be allowed to rely on the records of such negotiation before any arbitration or proceedings in any court.

Arbitration
13.2.1 If the Dispute is not resolved by such good faith negotiation within the period mentioned, the Parties agree to settle the Dispute through arbitration conducted by the sole arbitrator appointed by the Chairperson, NBA. The arbitration shall be governed by the Arbitration and Conciliation Act, 1996. The place of arbitration shall be Chennai, India. The language to be used in the arbitration proceedings shall be English.

13.2.2
The parties hereto agree that the award and determination of the arbitrator shall be final and binding on both parties hereto.
13.2.3 During the progress of arbitration, the Parties hereto shall continue to perform their obligations under this Agreement.

Attorney Fees
18.1 The Parties hereto agree that in the event that this Agreement becomes subject to litigation (either in Courts or before Arbitration) between the Parties hereto, the prevailing Party shall be entitled to an award of attorney's fees, costs, and interest at the rate of 15% from the other Party. The interest shall be calculated from the date of notice of the Dispute given in accordance with the terms of this Agreement.

Governing Law and Jurisdiction
This Agreement is governed by and is to be construed in accordance with the laws of the Republic of India without regard for conflicts of laws principles. The Parties irrevocably and unconditionally submits to the exclusive jurisdiction of the courts in Chennai, India and any courts which have jurisdiction to hear appeals from any of those courts and waives any right to object to any proceedings being brought in those courts.

Waiver
The Waiver by NBA, of any breach of any terms of this Agreement made by the Manufacturer shall not prevent the subsequent enforcement of that term and shall not be deemed a waiver of any subsequent breach.

Severability
If any part of this Agreement is declared or held invalid by a court for any reason, the invalidity of that part will not affect the validity of the remainder which will continue in full force and effect and be construed as if the Agreement had been executed without the invalid portion.

Modification
No amendment or modification of this Agreement shall be valid or binding upon the Parties, unless agreed upon by both Parties, made in writing, and signed on behalf of each of the Parties by their duly and legally authorized representative officers.

Entire Agreement
18.1 This Agreement constitutes the entire understanding between the parties as to the subject matter of this Agreement. This Agreement sets forth all representations forming part of or in any way affecting or relating to the subject matter of this Agreement.
18.2 The Parties acknowledge that there are no representations either oral or written, as regards the subject matter of this Agreement, between the NBA and the other than those expressly set out in this Agreement. All previous negotiations, understandings, representations, warranties, memoranda or commitments concerning the subject matter of this Agreement are merged in and superseded by this document and are of no effect.
For the removal of doubts, 'subject matter of this Agreement' is the transfer of results of research on any biological resource obtained from India.

Representations
19.1 Either Party represent to each other Party that it has the legal right and power to enter into this Agreement and to perform its obligations under the terms of this Agreement and the execution, delivery and performance of this Agreement by it has been duly and validly authorized by all necessary corporate action or Government action on its part.

19.2
The Parties further represent that this Agreement is valid and binding agreement of it, enforceable in accordance with its terms and the execution and performance of this Agreement by it does not, and other transactions contemplated by this Agreement do not, violate or conflict with or result in a breach of or constitute a default under its constitution or laws. This Agreement has been executed in Duplicate. Each of which shall be deemed to be an original, but all of which together shall constitute one and the same instrument.
IN WITNESS WHEREOF this Agreement has been executed by duly authorized representatives of the Parties on the day and the year first mentioned For National Biodiversity Authority: For the Researcher :

APPROVAL AGREEMENT FOR RESEARCH RESULTS
This Agreement is entered into as of the …………. day of ……………., 2005
Hereinafter, the NBA and the Technologist shall collectively be referred to as "the Parties" and individually as "Party".

WHEREAS:
NBA has been established by the Government of India under the powers granted to it by section 8 of the Biological Diversity Act 2002 (Act 18 of 2003). Under the said Act, NBA is the authority to permit access to any biological resources found within the territory of India.
Technologist is a Company/University/Individual, who/which has accessed the biological resources (and the associated knowledge) under the provisions of the Biological Diversity Act 2002 for the purposes of research/bio-survey and bio-utilisation. The Technologist has obtained certain 'Leads', which has got certain commercial value in the market.
Technologist has made an application in Form II, under Rule 17 of the Biological Diversity Rules 2004 to seek approval from the NBA to transfer these 'Leads' to a User.
The Parties hereto agree as follows:

Definitions
In this Agreement: (v) this Agreement includes all schedules and annexures to it; (g) if the date on or by which any act must be done under this document is not a Business Day, the act must be done on or by the next Business Day.
(h) All headings in this Agreement have been inserted as a matter of convenience and for reference only and in no way define, limit, enlarge, modify the scope or meaning of the Agreement or any of its provisions.

Grant of Approval
3.1 The Technologist requests for approval and the NBA hereby grants the approval to transfer the Lead subject to the terms and conditions set forth in this Agreement.

The
Technologist hereby agrees that this Agreement shall not in any way constitute or be presumed to constitute a partnership, joint venture or joint enterprise in any way or for any purpose between the Parties hereto or make them in any way liable as partners of or as agents for one another.

No
Party has the authority to act for or to assume any obligation or responsibility on behalf of the other Party and the relationship between the Parties is that of a person and a statutory authority competent to approve certain actions under the Act.

Assignment and Transfer
In the event of any assignment or transfer of this Agreement in whole or in part by the Technologist to any person whether voluntarily or involuntarily, by operation of law or otherwise, all obligations under this Agreement shall accrue on such assignee or transferee. The Technologist undertakes to include this Agreement as an appendix to the instrument making the assignment or transfer of this Agreement.

5.1
The NBA encourages the Technologist to obtain any kind of legal protection to the Lead, including obtaining intellectual property rights or maintaining it as a trade secret as deemed appropriate by the Technologist before transferring the Lead.

5.2
If the Lead is being transferred for further research and commercialization as a product, the agreement licensing the Lead to the User shall contain all the provisions of this Agreement. Such licensing/sub licensing agreement shall mention the existence of this Agreement and shall require such such licensor/sub-licensor to enter into agreement with the NBA as appropriate so as to ensure the proper flow of benefit to the benefit claimers. Modify this

All Licenses and sub licenses granted by the Technologist or User for Commercial
Utilisation shall ensure the flow of benefits to the benefit claimers and other stakeholders in India.

5.4
The Technologist, while applying for any legal protection for the Lead, undertakes to declare that the Biological Resources were obtained from India and in the event of the use of any associated knowledge obtained from a traditional healer or community, their permission will be sought and a proper acknowledgement of their contribution shall also be declared by the Technologist. 8.6 In the event of large amounts of raw material being required for Commercial Utilisation of the Lead, the Technologist/User/such person using the Lead will investigate the mass propagation of the material in India. Consideration will be given to sustainable harvest of the material while conserving the biological diversity of the region, and involvement of the local population in the planning and implementation stages, so as to generate employment to the local people. (e) any other information sought by the NBA by a written notice.

Reports and
9.2 The Technologist shall keep, and shall require all other persons with which it has entered into agreements as a direct or indirect result of this Agreement, accurate records (together with supporting documentation) required to determine the amount of royalties due to NBA. Such records shall be retained for at least three (3) years following the end of the reporting period to which they relate.
9.3 The records mentioned in clause 9.2 should be made available during normal business hours for audit by any person authorised by NBA, for the sole purpose of verifying reports and payments hereunder. In conducting audits pursuant to this clause, such person shall have access to all records which he reasonably believes to be relevant to the calculation of royalties. Such authorized person shall not disclose to NBA any information other than information relating to the accuracy of reports and payments made hereunder.

9.4
The audit by such authorized person shall be at the expense of NBA, except that if such audit shows an underreporting or underpayment in excess of five percent (5%) for any twelve (12) month period, then Technologist/such other person shall pay the cost of such examination as well as any additional sum that would have been payable to NBA had the Technologist/such other person reported correctly, plus interest on said sum at the rate of twelve per cent (12%) per month from the date of the incorrect report.

Liabilities and Indemnification
10.1 The Technologist shall be solely responsible for any claims by third parties arising from the Technologist's acts or omissions in the course of performing this Agreement and under no circumstances shall the NBA be held responsible for any such claims by third parties.
10.2 The Technologist shall indemnify and save harmless NBA and its employees from and against all claims, demands, losses, damages, costs (including attorney fees), actions, suits or other proceedings, all in any manner based upon, arising out of, related to, occasioned by or attributable to, any acts or conduct of the Technologist, its employees or agents, (whether by reason of negligence or otherwise) in the performance by the Technologist of the provisions of this Agreement or any activity undertaken or purported to be undertaken under the authority or pursuant to the terms of this Agreement.
10.3 The Technologist shall be deemed to be in material breach of this Agreement, if he fails to ensure proper flow of benefit sharing and other fees mentioned in clause 8 under this Agreement. The Technologist undertakes to make good all such losses as determined by the NBA in its yearly audits, within 15 days from the date of any notice to that effect is communicated to the Technologist.
10.4 The Technologist undertakes to pay a sum of ………..rupees for any material breach of this Agreement and further undertakes to pay such sum of …….rupees as determined by NBA as the loss incurred by the Republic of India or the stake holders involved.
10.5 Notwithstanding anything contained in this clause, the NBA shall not be restricted to make any disclosure of any confidential information, if in its reasonable opinion such disclosures become important to deal with any emergency conditions.

Term and Termination
11.1 This Agreement shall remain in force until the Technologist transfers the Lead or further improvements on it to the User and such User enters into an agreement with the NBA.

12.1
The NBA agree to treat as confidential any and all Confidential Information obtained from the Technologist marked as "CONFIDENTIAL" and to that end further agree that information disclosed pursuant to this Agreement relating to the Formulations, including efforts to commercialize the Formulations, shall be deemed Confidential Information.
12.2 Notwithstanding clause 12.1, Confidential Information may be disclosed to the extent required by any law or regulation of any governmental authority having jurisdiction over any of the Parties, with appropriate efforts made to maintain confidentiality.
12.3 NBA shall maintain Confidential Information in confidence, for as long as the confidential information does not fall within the Public Domain.
12.4 The Technologist undertakes to use its best endeavors to maintain the confidentiality of the Lead in such a manner that the benefits under this Agreement flows to the benefit claimers to the longest possible period.
12.5 All information exchanged between the Parties under this Agreement or during the negotiation of this Agreement, marked 'CONFIDENTIAL' by the Party, is confidential and may not be disclosed to any person except: (a) if it is necessary for the Technologist to disclose the information to a person in the course of negotiating a licence/Sublicence or other agreement concerning Commercial Utiliisation with the person, on condition that the person agrees to be bound by the terms of this clause; or (b) to the Party's professional advisers on condition that they agree to be bound by the terms of this clause

Force Majeure
The Researcher will not be liable for performance delays or for non-performance due to causes beyond its reasonable control.

Notice
14.1 Wherever in this Agreement, it is required or permitted that a communication, notice or demand be given or served by either Party to or on the other Party, such communication, notice or demand will be in writing and will be validly given or sufficiently communicated if forwarded by Registered mail acknowledgement due, email, telegram, telex or facsimile as follows: The addresses for delivery are: To the NBA: The (c) if sent by certified mail, four (4) days after the mailing thereof, provided that if there is a postal strike or other disruption such notice will be delivered by hand or electronic transmission.
14.3 The Parties may change their respective addresses for delivery by delivering notice of change as provided in this paragraph.

15.1
The Parties agree that any dispute, claim, or controversy concerning this Agreement or the termination of this Agreement, or any dispute, claim, or controversy arising out of or relating to any interpretation, construction, performance or breach of this Agreement, shall be settled by good faith negotiation between the Parties.
15.2 If the Parties fail to reach a settlement by a good faith negotiation within thirty days from the date on which such difference or dispute arose, such difference or dispute shall be settled by arbitration by a sole arbitrator to be appointed by the Chairperson of the NBA. The arbitration shall be governed by the Arbitration and Conciliation Act, 1996.
The place of arbitration shall be Chennai, India. The language to be used in the arbitration proceedings shall be English.

15.3
The Arbitrator shall decide the matter in dispute within six months from the date such reference was made to him and the decision of the arbitrator shall be final, conclusive and binding on the Parties.

15.4
The Parties hereto agree that in the event that this Agreement becomes subject to litigation (either in Courts or before Arbitration) between the Parties hereto, the prevailing Party shall be entitled to an award of attorney's fees, costs, and interest at the rate of 15% from the other Party. The interest shall be calculated from the date of notice of the Dispute given in accordance with the terms of this Agreement.

Governing Law and Jurisdiction
16.1 This Agreement is governed by and is to be construed in accordance with the laws of the Republic of India without regard for conflicts of laws principles. The Parties irrevocably and unconditionally submits to the exclusive jurisdiction of the courts in Chennai, India and any courts which have jurisdiction to hear appeals from any of those courts and waives any right to object to any proceedings being brought in those courts.

Waiver
The Waiver by NBA, of any breach of any terms of this Agreement made by the Manufacturer shall not prevent the subsequent enforcement of that term and shall not be deemed a waiver of any subsequent breach.

Severability
If any part of this Agreement is declared or held invalid by a court for any reason, the invalidity of that part will not affect the validity of the remainder which will continue in full force and effect and be construed as if the Agreement had been executed without the invalid portion.

Modification
No amendment or modification of this Agreement shall be valid or binding upon the Parties, unless agreed upon by both Parties, made in writing, and signed on behalf of each of the Parties by their duly and legally authorized representative officers. and …………… (Hereinafter referred to as "the Applicant", and includes the legal heirs, assigns, successors and administrators).

Entire
Hereinafter, the NBA and the Applicant shall collectively be referred to as "the Parties" and individually as "Party".

WHEREAS:
NBA has been established by the Government of India under the powers granted to it by section 8 of the Biological Diversity Act 2002 (Act 18 of 2003). Under the said Act, NBA is the authority to permit access to any biological resources found within the territory of India.
Applicant is a Company/University/Individual, who/which has accessed the biological resources (and the associated knowledge) under the provisions of the Biological Diversity Act 2002 for the purposes of research/bio-survey and bio-utilisation. The Applicant claims the use of the accessed biological resources and desires to obtain intellectual property rights over the same.
Applicant has made an application in Form III, under Rule 18 of the Biological Diversity Rules 2004 to seek approval from the NBA prior to obtaining the intellectual property rights on the invention involving the use of the accessed biological resource.
The Parties hereto agree as follows:

Definitions
In this Agreement: Act means the Biological Diversity Act 2003 (Act 18 of 2003) and includes the Rules/Regulations made under it.
Biological Resources: means biological resources as defined in the Act (and includes any associated knowledge) to which the Applicant had access to and which finds mention in the application seeking intellectual property rights made to the appropriate authority and which is more fully described in Schedule A to this Agreement.
Invention means the invention which the Applicant seeks to protect by applying for the intellectual property right and has been sufficiently described in Schedule B to this Agreement.
IPR means the intellectual property right granted to the Invention by the appropriate authority.
[Additions to me made in accordance with the needs]

Interpretations
Unless expressed to the contrary, in this Agreement: (a) words in the singular include the plural and vice versa; (b) any gender includes the other genders; (c) if a word or phrase is defined, its other grammatical forms have corresponding meanings; (d) a reference to: (i) a person includes a partnership, joint venture, unincorporated association, corporation and a government or statutory body or authority; (ii) any legislation or subordinate legislation includes any corresponding later legislation or subordinate legislation; (iii) an obligation includes a warranty or representation and a reference to a failure to comply with an obligation includes a breach of warranty or representation; (iv) writing includes any mode of representing or reproducing words in tangible and permanently visible form, and includes fax transmission; and (v) this Agreement includes all schedules and annexures to it; (g) if the date on or by which any act must be done under this document is not a Business Day, the act must be done on or by the next Business Day.
(h) All headings in this Agreement have been inserted as a matter of convenience and for reference only and in no way define, limit, enlarge, modify the scope or meaning of the Agreement or any of its provisions.

Grant of Approval
3.1 The Applicant requests for approval and the NBA hereby grants the approval to seek intellectual property rights protection over the Invention in the territories mentioned in Schedule C subject to the terms and conditions set forth in this Agreement.
3.2 The Applicant agrees to take prior approval of NBA in the event of seeking intellectual property rights protection in any other territory not mentioned in Schedule C.
3.3 The Parties hereby agree that this Agreement shall not in any way constitute or be presumed to constitute a partnership, joint venture or joint enterprise in any way or for any purpose between the Parties hereto or make them in any way liable as partners of or as agents for one another.

No
Party has the authority to act for or to assume any obligation or responsibility on behalf of the other Party and the relationship between the Parties is that of a person and a statutory authority competent to approve certain actions under the Act.

Assignment and Transfer
In the event of any assignment or transfer (by way of licensing or any other means) of the IPR in whole or in part by the Applicant to any person whether voluntarily or involuntarily, by operation of law or otherwise, all obligations under this Agreement shall accrue on such assignee or transferee. The Applicant undertakes to attach this Agreement as an appendix to the instrument making the assignment or transfer of IPR.

The Applicant undertakes to:
A. notify in writing to the NBA on the grant of IPR, within thirty days from the grant.. B. Keep NBA informed of any commercialization made on the IPR granted C. Share benefits obtained as a result of obtaining the IPR with the different Stakeholders as directed by the NBA D. employ local people, in the event the Applicant chooses to set up his/its own business unit in India to exploit the IPR granted.

5.2
The Applicant will seek to utilize India as its first source of supply and/or cultivation for raw (natural product) materials required for exploitation of the IPR, if such material can be made available in quantities and quality sufficient for use by the Applicant at a mutually agreeable fair price. If such material must be cultivated, the Applicant agrees to seek to utilize territory under the control of the Republic of India as its first source of such cultivation efforts.

All
Licenses and sub-licenses granted by the Applicant for exploiting the IPR shall contain such clauses from this Agreement which ensures the flow of benefits to the benefit claimers and other stakeholders in India, more particularly to utilize India as first source of supply and/or cultivation for raw materials (Biological Resources) required for exploitation of the IPR.

No Transfer of Biological Resources or Associated Knowledge
6.1 The Approval granted under this Agreement shall not be construed as an approval granted to the Applicant for transfer, distribute or part with in any manner, the Biological Materials obtained by the Applicant.
6.2 If the Applicant desires to use the Biological Materials for commercial purposes to exploit the IPR, the Applicant agrees to make an application under the appropriate provisions and forms under the Act for access to Biological Resources as a raw material for commercial production. (This fee will be decided by the NBA taking several factors like whether the Technologist has been successful in selecting India as source country for raw material procurement) (Conservation fee will be used to meet the expenses associated with conservation of endangered species) 7.4 The Applicant shall pay to the NBA, by the 31 st of March every year, during the term of this Agreement a royalty of……% of the royalty it gets from the direct or indirect exploitation of the IPR, which shall promptly be transferred by the NBA to the benefit claimers in accordance with the Act.

Fees, Royalty and other Benefit Sharing
7.5 The Applicant undertakes to use his best endeavours to transfer the technology to any Indian entity and inspect the feasibility to carry on large scale production of the Product in India involving the local people.
7.6 In the event of large amounts of raw material being required for exploiting the IPR, the Applicant will investigate the mass propagation of the material in India. Consideration will be given to sustainable harvest of the material while conserving the biological diversity of the region, and involvement of the local population in the planning and implementation stages, so as to generate employment to the local people.

8.1
The Applicant shall submit to NBA within sixty days after each half year ending September 30 and March 31, a report setting forth the following: (a) the number of agreements entered in to for the commercial exploitation of the IPR (b) the amount of royalty received by the Applicant as a result of such agreements.
(c) any Products manufactured by the Applicant, based on the IPR or improvements made on it and made available in the market.
(d) the total billings of such Products (ex factory) (e) any other information sought by the NBA by a written notice.

8.2
The Applicant shall keep accurate records (together with supporting documentation) required to determine the amount of royalties due to NBA. Such records shall be retained for at least three (3) years following the end of the reporting period to which they relate.

8.3
The records mentioned in clause 8.2 should be made available during normal business hours for audit by any person authorised by NBA, for the sole purpose of verifying reports and payments hereunder. In conducting audits pursuant to this clause, such person shall have access to all records which he reasonably believes to be relevant to the calculation of royalties. Such authorized person shall not disclose to NBA any information other than information relating to the accuracy of reports and payments made thereunder.

8.4
The audit by such authorized person shall be at the expense of NBA, except that if such audit shows an underreporting or underpayment in excess of five percent (5%) for any twelve (12) month period, then Applicant shall pay the cost of such examination as well as any additional sum that would have been payable to NBA had the Applicant reported correctly, plus interest on said sum at the rate of twelve per cent (12%) per month from the date of the incorrect report.

Liabilities and Indemnification
9.1 The Applicant shall be solely responsible for any claims by third parties arising from the Applicant's acts or omissions in the course of performing this Agreement and under no circumstances shall the NBA be held responsible for any such claims by third parties.
9.2 The Applicant indemnifies and save harmless NBA and its employees from and against all claims, demands, losses, damages, costs (including attorney fees), actions, suits or other proceedings, all in any manner based upon, arising out of, related to, occasioned by or attributable to, any acts or conduct of the Applicant, its employees or agents, (whether by reason of negligence or otherwise) in the performance by the Applicant of the provisions of this Agreement or any activity undertaken or purported to be undertaken under the authority or pursuant to the terms of this Agreement.
9.3 The Applicant shall be deemed to be in material breach of this Agreement, if he fails to ensure proper flow of benefit sharing and other fees mentioned in clause 7 under this Agreement. The Applicant undertakes to make good all such losses as determined by the NBA in its yearly audits, within 15 days from the date of any such notice to that effect is communicated to the Applicant.
9.4 The Applicant undertakes to pay a sum of ………..rupees for any material breach of this Agreement and further undertakes to pay such sum of …….rupees as determined by NBA as the loss incurred by the Republic of India or the stake holders involved.

Term and Termination
This Agreement shall remain in force until the validity of the IPR that gives a market monopoly to the Applicant. There shall be no termination of this Agreement prior to the period mentioned above.

11.1
The NBA agree to treat as confidential any and all Confidential Information obtained from the Applicant marked as "CONFIDENTIAL" and to that end further agree that information disclosed pursuant to this Agreement relating to the Formulations, including efforts to commercialize the Formulations, shall be deemed Confidential Information.
11.2 Notwithstanding clause 12.1, Confidential Information may be disclosed to the extent required by any law or regulation of any governmental authority having jurisdiction over any of the Parties, with appropriate efforts made to maintain confidentiality. Confidential Information may also be disclosed to the Party's professional advisers, if it becomes necessary, on condition that they agree to be bound by the terms of this clause 11.3 Both Parties shall maintain Confidential Information in confidence, for as long as such confidential information does not fall within the Public Domain.

Notice
12.1 Wherever in this Agreement, it is required or permitted that a communication, notice or demand be given or served by either Party to or on the other Party, such communication, notice or demand will be in writing and will be validly given or sufficiently communicated if forwarded by Registered mail acknowledgement due, email, telegram, telex or facsimile as follows: rate of 15% from the other Party. The interest shall be calculated from the date of notice of the Dispute given in accordance with the terms of this Agreement.

Governing Law and Jurisdiction
This Agreement is governed by and is to be construed in accordance with the laws of the Republic of India without regard for conflicts of laws principles. The Parties irrevocably and unconditionally submits to the exclusive jurisdiction of the courts in Chennai, India and any courts which have jurisdiction to hear appeals from any of those courts and waives any right to object to any proceedings being brought in those courts.

Waiver
The Waiver by NBA, of any breach of any terms of this Agreement made by the Manufacturer shall not prevent the subsequent enforcement of that term and shall not be deemed a waiver of any subsequent breach.

Severability
If any part of this Agreement is declared or held invalid by a court for any reason, the invalidity of that part will not affect the validity of the remainder which will continue in full force and effect and be construed as if the Agreement had been executed without the invalid portion.

Modification
No amendment or modification of this Agreement shall be valid or binding upon the Parties, unless agreed upon by both Parties, made in writing, and signed on behalf of each of the Parties by their duly and legally authorized representative officers.

Entire Agreement
18.1 This Agreement constitutes the entire understanding between the parties as to the subject matter of this Agreement. This Agreement sets forth all representations forming part of or in any way affecting or relating to the subject matter of this Agreement.
18.2 The Parties acknowledge that there are no representations either oral or written, as regards the subject matter of this Agreement, between the NBA and the Applicant other than those expressly set out in this Agreement. All previous negotiations, understandings, representations, warranties, memoranda or commitments concerning the subject matter of this Agreement are merged in and superseded by this document and are of no effect.
For the removal of doubts, 'subject matter of this Agreement' is the approval from the NBA to the Applicant to seek intellectual property rights in the territories mentioned in Schedule C for the Invention described in Schedule B.

Representations
19.1 Either Party represent to each other Party that it has the legal right and power to enter into this Agreement and to perform its obligations under the terms of this Agreement and the execution, delivery and performance of this Agreement by it has been duly and validly authorized by all necessary corporate action or Government action on its part.
19.2 The Parties further represent that this Agreement is valid and binding agreement of it, enforceable in accordance with its terms and the execution and performance of this Agreement by it does not, and other transactions contemplated by this Agreement do not, violate or conflict with or result in a breach of or constitute a default under its constitution or laws. and any other Appendix that may be added subsequently under the provisions of this Agreement. The application made in Form III mentioned in the recitals of this Agreement shall also form a part of this Agreement.
This Agreement has been executed in Duplicate. Each of which shall be deemed to be an original, but all of which together shall constitute one and the same instrument.
IN WITNESS WHEREOF this Agreement has been executed by duly authorized representatives of the Parties on the day and the year first mentioned For National Biodiversity Authority: For the Applicant:

MATERIAL TRANSFER AGREEMENT
This Agreement is entered into as of the …………. day of ……………., 2005 the approval agreement executed on ……. Day of …..2005, which agreement shall be attached as an appendix to the written agreement between the Transferor and Transferee.
Provided that, in the absence of any agreement between the NBA and the Transferor, the Transferor shall attach the standard agreement (in accordance with the purpose of the transferee) as available with the NBA and all clauses therein shall be binding on the Transferee.
The Transferee shall have no rights to directly access the Biological Material other than from the Transferor.
The Transferor shall indemnify NBA for any breach of the clauses of this agreement or for any breach made by the transferee of any of the clauses of the agreement attached as an appendix to the agreement between the Transferor and the Transferee.

Term
This Agreement, unless terminated as provided herein, shall remain in effect for a period of one year from the date on which the approval is given by the NBA to the Transferor for the transfer of the Biological Resources.
All Clauses of the agreement attached as an appendix to the agreement between the Transferor and the Transferee shall apply in all aspects where this contract is silent. This Agreement has been executed in Duplicate. Each of which shall be deemed to be an original, but all of which together shall constitute one and the same instrument. The Authority is requested to approve The Authority approved the minutes of the minutes of the above meeting.