MOSAICC Micro-Organisms Sustainable use and Access Regulation International Code of Conduct, Updated September 2009

Subject matter	Microbial genetic resources
Summary of use(s)	Category 1: Use for test, reference, bioassay, and control (covering only their use within the framework of the corresponding official (inter)national test-, bioassay and control protocols); use for training and research purposes; Category 2: Commercial use. Commercial use of MGRs includes but is not limited to the following activities: sale, patenting, obtaining or transferring intellectual property rights or other tangible or intangible rights by sale or licence, product development and seeking pre-market approval.
Purpose or background	MOSAICC is a voluntary Code of Conduct. It is developed to facilitate access to microbial genetic resources (MGRs) and to help partners to make appropriate agreements when transferring MGRs, in the framework of the Convention on Biological Diversity (CBD) and other applicable rules of international and national laws. MOSAICC is a tool to support the implementation of the CBD at the microbial level; it can also serve as a model when dealing with genetic resources other than MGRs. MOSAICC is the result of the European Commission DG Research funded project called “Elaboration and diffusion of a code of conduct for the access to and sustainable use of microbial resources within the framework of the convention on biological diversity”. MOSAICC was first issued in spring ’99, two years before the Bonn Guidelines, as result of five successive drafts improved through dialogue between MOSAICC partners and a network of experts of more than 15 different nationalities. The present version is an update that takes over the innovative ideas developed the last decades by life sciences and social sciences researchers to meet the evolving socio-economic environment. For the purpose of this database the Model Agreements are reproduced; the full Code of Conduct is available at: http://bccm.belspo.be/projects/mosaicc/
Contact details	BCCM, Belgian Federal Science Policy, Louise Avenue 231, B-1050 Brussels, Phone: +32-2-238.34.62, Fax: +32-2-230.59.12 http://bccm.belspo.be/projects/mosaicc/

MODEL DOCUMENTS

List of documents that should « cover » the MGRs to guarantee a transfer consistent with the principles of the CBD.

ACCESS TO IN SITU MGRS

· Prior Informed Consent - PIC obtained from a competent authority

· Optional: permission of the landowner and/or usufructuary

· Material Transfer Agreement - MTA

ACCESS TO EX SITU MGRS

· Material Transfer Agreement - MTA

· One or more of these options: use of GUIDs, reference to the origin, reference of the PIC, reference of the “accession form” or equivalent document delivered when the MGRs were originally isolated from in situ conditions and deposited in ex situ collections (See pages 8 and 9)

MOSAICC recommends that each document (PIC-application, PIC, MTA, accession form):

− fully identifies the parties involved, as well as their representative(s);

− is dated;

− contains a clear indication about duration of its terms;

− in the case of PIC-application and PIC-certificate, is signed by the sender;

− in the case of MTA, is signed by all parties involved, or seen as approved on basis of the purchase order or the notice of receipt of the MGRs. Both options are legally valid. The choice depends on the Provider’s policy. Furthermore, considering that electronic ordering via internet is becoming a preferred way to purchase a MGRs from a culture collection/ biological resource centre, the buyer’s consent via “click and wrap” or similar procedure like “shrink wrap” at delivery will become the option by default. It has the advantage of facilitating electronic recording and conveyance of the transfers, eventually by using GUIDs.

MOSAICC proposes:

− a model of Material Transfer Agreement;

− a PIC-application model form for access to in situ MGRs;
− a model of PIC for access to in situ MGRs.

MATERIAL TRANSFER AGREEMENT – MTA

DEFINITIONS

- PROVIDER: whoever provides MATERIAL to RECIPIENT.

- RECIPIENT: legal entity or individual who purchases and/or uses the MATERIAL.

- DEPOSITOR: legal entity or individual who deposits ORIGINAL MATERIAL in the custody of the PROVIDER.

- RESEARCH GROUP: Entitled scientists working in a same laboratory, or contractually bound to work on the same research topic.

- MATERIAL: ORIGINAL MATERIAL, PROGENY, and UNMODIFIED DERIVATIVES. The MATERIAL shall not include MODIFICATIONS. The description of the MATERIAL being transferred is on delivery note and invoice.

- ORIGINAL MATERIAL: that which was supplied to the PROVIDER by the DEPOSITOR.

- PROGENY: Unmodified descendant from the ORIGINAL MATERIAL, such as cell from cell, or organism from organism.

- UNMODIFIED DERIVATIVES: Substances created by the RECIPIENT which constitute an unmodified functional subunit of the MATERIAL.

- MODIFICATIONS: Substances created by the RECIPIENT using the MATERIAL, which are not ORIGINAL MATERIAL, PROGENY or UNMODIFIED DERIVATIVES, and which have new properties.

- LEGITIMATE EXCHANGE: The transfer of the MATERIAL within the Research Group. LEGITIMATE EXCHANGE also includes the transfer of MATERIAL between named culture collections/biological resources centres for accession purposes, provided that further distribution by the receiving culture collections/biological resources centre is under MTA provisions compatible and equivalent as those in place at the supplying collection.

- COMMERCIAL USE: the use of the MATERIAL for the purpose of profit. COMMERCIAL USE shall include the sale, leasing, exchange, license, or other transfer of MATERIAL for profit purposes. COMMERCIAL USE shall also include uses of MATERIAL to establish service business activities, to manufacture products, to perform contract research, or to conduct research activities for profit purposes.

PROVISIONS

³³The RECIPIENT will respect, if applicable, the accompanying PIC-terms and the terms laid down in the previous Material Transfer Agreement (see annexes).

³⁴The RECIPIENT will use the MGRs described and listed in annex, in a sustainable way, for bona fide purposes and in full respect of the principles of the Convention on Biological Diversity and other applicable rules of international and national laws.

³⁵The RECIPIENT will not distribute the MGRs delivered.

The RECIPIENT may distribute the MGRs in case of legitimate exchanges, provided that the following conditions are observed:

The RECIPIENT will keep records of the full co-ordinates of all downstream recipients of the MGRs concerned. This information will be available on request (= monitoring the transfers).

The RECIPIENT will transmit to the PROVIDER, as far as applicable, information (e.g. intentions for commercial use,) provided by the downstream recipient(s) of the MGRs concerned (= information feedback);

³⁶The RECIPIENT and the PROVIDER distinguish the following categories of use of MGRs:

Category 1: Use for test, reference, bioassay, and control (covering only their use within the framework of the corresponding official (inter)national test-, bioassay and control protocols); use for training and research purposes;

Category 2: Commercial use. Commercial use of MGRs includes but is not limited to the following activities: sale, patenting, obtaining or transferring intellectual property rights or other tangible or intangible rights by sale or licence, product development and seeking pre-market approval.

For category 1 uses:

The RECIPIENT will not claim ownership over the MGRs received, nor seek intellectual property rights over them or related information. If the RECIPIENT wishes to utilise or exploit such organisms commercially he will first inform the PROVIDER; when applicable, suitable and adequate recompense to those entitled to be rewarded, and the country of origin will be discussed in the spirit of the Convention on Biological Diversity.

THE RECIPIENT will ensure that any individual or institution, to which the RECIPIENT makes samples of the MGRs available, is bound by the same provision.

For category 2 uses,

In order to ensure adequate benefit sharing with the country of origin and « names of those entitled to be rewarded », according to the principles of the Convention on Biological Diversity, the RECIPIENT will immediately inform the PROVIDER and the country where the MGRs were originally accessed, of the intended commercial use(s) of the MGRs and/or derived technology and/or related information. The terms upon which benefit sharing with the stakeholders takes effect are laid down in annex.

For all categories of uses,

The RECIPIENT will mention the PROVIDER, the strain reference number and the country of origin in publication presenting scientific results and related information resulting from the use of the MGRs.

33 Accompanying terms: Reference of PIC, mention of the country of origin; previous MTA-terms if any

34 Basic terms :

Description of MGRs (country of origin, place and date of isolation, strain reference number, identification data,
name of the individual that has isolated the strain from in situ conditions or, if individual’s name is not available, the name of the institution (legal entity) that employed the individual at the time of the isolation of the strain.) ; Bona fide and sustainable use, following the CBD-principles ;

Clause governing the payment of the costs of handling.

Information about provider and recipient: names, addresses

Scientific feedback: publication will mention provider, strain reference number and country of origin. .

35 Key-terms that differentiate MTA excluding or allowing distribution to 3^rdparties

36 Use-specific terms

Category 1: Use for test, reference, bioassay, control, training and research purposes.

− No commercial use ;

− No IPR on MGRs, derived technology and information ;

Category 2 : Commercial use

− Terms on IPR, information feedback about patent application; need precise terms for benefit-sharing (see additional terms).

MTA ADDITIONAL TERMS CHECK LIST

IPR related to MGRs and derived technology

Different regimes³⁷ of IPR-ownership could be related to different values added by the respective partners during the acquirement (isolation, purification) and/or the characterisation of MGRs (identification of the MGR, detection of possible use(s), etc.).

Check the following categories: IPR-ownership of the MGRs

IPR-ownership of the derived technology

Terms on training, technical and scientific co-operation, technology transfer, exchange of information and publication policy³⁸

Terms providing possibilities for capacity building in, among others, taxonomy and general microbiology for the provider of microbial genetic resources should be emphasised and considered as important as financial arrangements. MOSAICC recommends partners to look for co-operative research programmes since as in most cases, the best training can be provided through technical and scientific co-operation.

Place and ways of conservation of MGRs

International co-operation can lead to the establishment of conservation facilities in the country of origin or to the development of agreements between on the one hand countries of origin having no conservation facilities yet and on the other hand foreign microbial genetic resources centres³⁹.

Partnerships involving other stakeholders than provider and recipient of MGRs, including indigenous and local communities

MOSAICC recommends that partners include indigenous or local communities as parties of an agreement in so far the community is:

- owner or usufructuary of the area where the in situ MGRs where accessed;

- represented by officially recognised representative(s) and

- willing to preserve and maintain her knowledge, innovations and practices relevant for the conservation and sustainable use of MGRs (cf. CBD-article 8 (j)).

Warranties and liability

Stipulate what the warranties offered by the providers of MGRs are. Set who is liable for damage to third parties.

Monetary terms

MOSAICC recommends that monetary compensations to those that provide or enable access to MGRs should be partly dedicated to technical and scientific co-operation programmes.

- Initial, up-front payment

Initial payments can be made before or after accessing the MGRs, but this always independently of the possible, successful commercial use of the MGRs. MOSAICC recommends calculating the importance of the initial payments in terms of the actual involvement of the provider in the delivery of the MGRs⁴⁰.

- Milestones payments

Payments related to the progress made in the development of a product or process that could be commercialised in fine.

- Royalty payments

Royalty payments are fully dependent on the successful commercial use of the MGRs concerned. Agreements should always make reference to net royalties⁴¹.

Applicable laws and competent authorities

Usually, the applicable laws are these of the country where the culture collection is vested. Unfortunately, there is no agreement on this matter at international level. Specify the applicable laws to avoid uncertainty.

Competent courts are those of the judicial district of the culture collection establishment.

37 For instance : - single ownership or co-ownership of the IPR;
- a single or different regimes of IPR-ownership, and the latter depending on the category of MGRs.

38 As the publication of results of the joint programme might prohibit a successful patent application, no publication should be made without the written agreement of the concerned partner. It is to remember that scientific publications should always mention provider, strain reference number and country of origin.

39 In this case, a country could transfer ex-situ MGRs to (an) ex-situ resource centre(s) in (an)other country(ies). This transfer should be covered by an extended MTA including provisions for access and benefit-sharing modalities. Detailed terms may be desired by the respective partners, for example by distinguishing type strains from non-type strains, or by making ad hoc agreements for herbarium material (in case of fungal material) etc.

40 For example: local community participating or not to field survey, costs of maintenance of ex-situ MGRs, etc.

41 Net royalties mean the gross amount of royalties, license fees, profits or any other payments which result from the use of a MGR and derived technology, less: - the costs incurred by the royalty paying partner to develop a patentable application making use of the MGRs; - the costs incurred by the royalty paying partner for patenting derived technology;

- the costs of marketing the application.

Examples of Prior Informed Consent (PIC) documents

Considering the minimal information necessary for an authority to assess the purposes and the lawfulness of a demand, a PIC application form must include a minimum of data: information about the applicant, the time frame, the area where the material is accessed, the kind of biological resource, and reference to a Material Transfer Agreement if any. The way it is put in form is secondary; the models hereunder are examples. In cases where the authorisation of a third party (right holders like usufructuary or landowner) is required, a copy should be annexed.

PIC application form for access to in situ MGRs

(Date)

(Name and address of the PIC-provider)

Dear ( ),

According to article 15 of the Convention on Biological Diversity (CBD) stating that «the authority to determine access to genetic resources rests with the national governments and is subject to national legislation » and that «Each Contracting Party shall endeavour to create conditions to facilitate access to genetic resources for environmentally sound uses by other Contracting Parties and not to impose restrictions that run counter to the objectives of this Convention », as well that «access to genetic resources shall be subject to prior informed consent of the Contracting Party providing such resources »;

and, as ratified by (Name of the Country where one wants to access MGRs),

I would like to get access to (Name of the field survey area), as well as to its genetic resources, more specifically samples or isolates from (name or description of group of plant, animal or microbial resources), with your prior informed consent (PIC), during the period and under the conditions specified in annex (copy of MTA if any; copy of authorisation of third party if any).

(Name, address and signature of the PIC-applicant)

In return, the PIC certificate should confirm the ranges / limits of time, of geographic area and of kind of biological resources it is valid for. Complementary information concerning relevant legislation is recommended.

PIC certificate for access to in situ MGRs.

(Date)

(Name and address of the PIC applicant )

Dear (Name of the PIC-applicant),

In reply to your PIC-application of (date of written demand) as annexed, we have the pleasure to provide you with the present PIC, in conformity with the CBD provisions, and national regulations referred to in annex.

As competent authority for controlling in situ access to the genetic resources of (Name of the field of competence or geographical area of competence), we confirm that the present PIC is valid for access to in situ MGRs from (Name of the field survey area). It grants access to this area from (date) to (date). This PIC is not transferable from one organisation to another without written agreement of the undersigned authority.

(Place and date of issue, official administrative seals, name, address, and signature of the CBD PICprovider.)

* When applicable