BUDAPEST TREATY REGULATIONS

Rule 6. Making the Original Deposit

6.1 Original Deposit

(a) The microorganisms transmitted by the depositor to the international depositary authority shall, except where Rule 6.2 applies, be accompanied by a written statement bearing the signature of the depositor and containing:

(i) an indication that the deposit is made under the Treaty and an undertaking not to withdraw it for the period specified in Rule 9.1;

(ii) the name and address of the depositor;

(iii) details of the conditions necessary for the cultivation of the microorganism, for its storage and for testing its viability and also, where a mixture of microorganisms is deposited, descriptions of the components of the mixture and at least one of the methods permitting the checking of their presence.

(iv) an identification reference (number, symbols, etc.) given by the depositor to the microorganism;

(v) an indication of the properties of the microorganism which are or may be dangerous to health or the environment, or on indication that the depositor is not aware of such properties.

(b) It is strongly recommended that the written statement referred to in paragraph (a) should contain the scientific description and/or proposed taxonomic designation of the deposited microorganism.

6.2 New Deposit

(a) Subject to paragraph (b), in the case of a new deposit made under Article 4, the microorganism transmitted by the depositor to the international depositary authority shall be accompanied by a copy of the receipt of the previous deposit, a copy of the most recent statement concerning the viability of the microorganism which was the subject of the previous deposit indicating that the microorganism is viable and a written statement bearing the signature of the depositor and containing:

(i) the indications referred to in Rule 6.1(a)(I) to (v);

(ii) a declaration stating the reason relevant under Article 4(1)(a) for making the new deposit, a statement alleging that the microorganism which is the subject of the new deposit is the same as that which was the subject of the previous deposit, and an indication of the date on which the depositor received the notification referred to in Article 4(1)(a) or, as the case may be, the date of the publication referred to in Article 4(1)(e);

(iii) where a scientific description and/or proposed taxonomic designation was/were indicated in connection with the previous deposit, the most recent scientific description and/or proposed
taxonomic designation as communicated to the international depositary authority with which the previous deposit was made.

(b) Where the new deposit is made with the international depositary authority with which the previous deposit was made, paragraph (a)(I) shall not apply.

(c) For the purposes of paragraphs (a) and (b) and of Rule 7.4, "previous deposit" means,

(i) where the new deposit has been preceded by one or more other new deposits: the most recent of those other new deposits;

(ii) where the new deposit has not been preceded by one or more other new deposits: the original deposit.

6.3 Requirements of the International Depositary Authority

(a) Any international depositary may require:

(i) that the microorganism be deposited in the form and quantity necessary for the purposes of the Treaty and these Regulations;

(ii) that a form established by such authority and duly completed by the depositor for the purposes of the administrative procedures of such authority be furnished;

(iii) that the written statement referred to in Rule 6.1(a)(I) or 6.2(a) be drafted in the language, or in any of the languages, specified by such authority, it being understood that such specification must at least include the official language or languages indicated under Rule 3.1(b)(v);

(iv) that the fee for storage referred to in Rule 12.1(a)(I) be paid; and

(v) that, to the extent permitted by the applicable law, the depositor enter into a contact with such authority defining the liabilities of the depositor and the said authority.

(b) Any international depositary authority shall communicate any such requirements and any amendments thereof the International Bureau.

6.4 Acceptance Procedure

(a) The international depositary authority shall refuse to accept the microorganism and shall immediately notify the depositor in writing of such refusal an of the reason therefor:

(i) where the microorganism is not of a kind of microorganism to which the assurances furnished under Rule 3.1(c)(iii) or 3.3 extend;

(ii) where the properties of the microorganism are so exceptional that the international depositary authority is technically not in a position to perform the tasks in relation to it that it must perform under the Treaty and these Regulations;

(iii) where the deposit is received in a condition which clearly indicates that the microorganism is missing or which precludes for scientific reasons the acceptance of the microorganism.

(b) Subject to paragraph (a), the international depositary authority shall accept the microorganism when all the requirements of Rule 6.1(a) or 6.2(a) and Rule 6.3(a) are not complied with. If any of those requirements are not complied with, the international depositary authority shall immediately notify the depositor in writing of that fact and invite him to comply with those requirements.

(c) When the microorganism has been accepted as an original or new deposit, the date of that original or new deposit, the date of that original or new deposit, as the case may be, shall be the date on which the microorganism was received by the international depositary authority.

(d) The international depositary authority shall, on the request of the depositor and provided that all the requirements referred to in paragraph (b) are complied with, consider a microorganism, deposited before the acquisition by such authority of the status of international depositary authority, to have been received, for the purposes of the Treaty, on the date on which such status was acquired.

Rule 7. Receipt

7.1 Issuance of Receipt

The international depositary authority shall issue to the depositor, in respect of each deposit of microorganism effected with it or transferred to it, a receipt in attestation of the fact that is has received and accepted the microorganism.

7.2 Form; Language; Signature

(a) Any receipt referred to in Rule 7.1 shall be established on a form called an "international form" a model of which shall be established by the Director General in those languages which the Assembly shall designate.

(b) Any words or letters filled in the receipt in characters other than those of the Lain alphabet shall also appear therein transliterated in characters of the Latin alphabet.

(c) The receipt shall bear the signature of the person or persons having the power to represent the international depositary authority or that of any other official of that authority duly authorized by the said person or persons.

7.3 Contents in the Case of the Original Deposit

Any receipt referred to in Rule 7.1 and issued in the case of an ordinal deposit shall indicate that it is issued by the depositary institution in its capacity of international depositary authority under the Treaty and shall contain at least the following indications:

(i) the name and address of the international depositary authority;

(ii) the name and address of the depositor;

(iii) the date of the original deposit as defined in Rule 6.4(c);

(iv) the identification reference (number, symbols, etc.) given by the depositor to the microorganism;

(v) the accession number given by the international depositary authority to the deposit;

(vi) where the written statement referred to in Rule 6.1(a) contains the scientific description of the microorganism, a reference to that fact.

7.4 Contents in the Case of the New Deposit

Any receipt referred to in Rule 7.1 and issued in the case of a new deposit effected under Article 4 shall be accompanied by a copy of the receipt of the previous deposit (within the meaning of Rule 6.2(c)) and a copy of the most recent statement concerning the viability of the microorganism which was the subject of the previous deposit (within the meaning of Rule 6.2(c)) indicating that the microorganism is viable, and shall at least contain:

(i) the name and address of the international depositary authority,

(ii) the name and address of the depositor;

(iii) the date of the new deposit as defined in Rule 6.4(c);

(iv) the identification reference (number, symbols, etc.) given by the depositor to the microorganism;

(v) the accession number given by the international depositary authority to the new deposit;

(vi) an indication of the relevant reason and the relevant date as stated by the depositor in accordance with Rule e6.2(a)(ii);

(vii) where Rule 6.2(a)(iii) applies, a reference to the fact that a scientific description and/or a proposed taxonomic designation has/have been indicated by the depositor;

(viii) the accession number given to the previous deposit (within the meaning of Rule 6.2(c)).

7.5 Receipt in the Case of Transfer

The international depositary authority to which samples of microorganisms are transferred under Rule 5.1(a)(I) shall issue to the depositor, in respect of each deposit in relation with which a sample is transferred, a receipt indicating that it is issued by the depositary institution in its capacity of international depositary authority under the Treaty and containing at least:

(i) the name and address of the international depositary authority;

(ii) the name and address of the depositor

(iii) the date on which the transferred sample was received by the international depositary authority (date of the transfer);

(iv) the identification reference (number, symbols, etc.) given by the depositor to the microorganism;

(v) the accession number given by the international depositary authority;

(vi) the name and address of the international depositary authority from which the transfer was effected;

(vii) the accession number given by the international depositary authority from which the transfer was effected;

(viii) where the written statement referred to in Rule 6.1(a) or 6.2(a) contained the scientific description and/or proposed taxonomic designation of the microorganism, or where such scientific description and/or proposed taxonomic designation was/were indicated or amended under Rule 8.1 at a later date a reference to that fact.

7.6 Communication of the Scientific Description and/or Proposed Taxonomic Designation

On request of any party entitled to receive a sample of the deposited microorganism under Rule 11.1, 11.2 or 11.3 the international depositary authority shall communicate to such party the most recent scientific description and/or proposed taxonomic designation referred to in Rule 6.1(b), 6.2(a)(iii) or 8.1(b)(iii).

Rule 8. Later Indication or Amendment of the Scientific Description and/or Proposed Taxonomic Designation

8.1 Communication

(a) Where, in connection with the deposit of a microorganism, the scientific description and/or taxonomic designation of the microorganism was/were not indicate, the depositor may later indicate or, where already indicated, may amend such description and/or designation.

(b) Any such later indication or amendment shall be made in a written communication, bearing the signature of the depositor, addressed to the international depositary authority and containing:

(i) the name and address of the depositor;

(ii) the accession number given by the said authority;

(iii) the scientific description and/or proposed taxonomic designation of the microorganism:

(iv) in the case of an amendment, the last preceding scientific description and/or proposed taxonomic designation.

8.2 Attestation

The international depositary shall, on the request of the depositor having made the communication referred to in Rule 8.1 deliver to him an attestation showing the data referred to in Rule 8.1(b)(i) to (iv) and the date of receipt of such communication.

Rule 9. Storage of Microorganisms

9.1 Duration of the Storage

Any microorganism deposited with an international depositary authority shall be stored by such authority, with all the care necessary to keep it viable and uncontaminated, for a period of at least five years after the most recent request for the furnishing of a sample of the deposited microorganism was received by the said authority and, in any case, for a period of at least 30 years after the date of the deposit.

9.2 Secrecy

No international depositary authority shall give information to anyone whether a microorganism has been deposited with it under the Treaty. Furthermore, it shall not give any information toanyone concerning any microorganism deposited with it under the Treaty except to an authority, natural person or legal entity which is entitled to obtain a sample of the said microorganism under Rule 11 and subject to the same conditions as provided in that Rule.

Rule 10. Viability Test and Statement

10.1 Obligation to Test

The international depositary authority shall test the viability of each microorganism deposited with it:

(i) promptly after any deposit referred to in Rule 6 or any transfer referred to in Rule 5.1;

(ii) at reasonable intervals, depending on the kind of microorganism and its possible storage conditions, or at any time, if necessary for technical reasons;

(iii) at any time, on the request of the depositor.

10.2 Viability Statement

(a) The international depositary authority shall issue a statement concerning the viability of the deposited microorganism:

(i) to the depositor, property after any deposit referred to in Rule 6 or any transfer referred to in Rule 5.1;

(ii) to the depositor , on his request, at any time after the deposit or transfer;

(iii) to any industrial property office, other authority, natural person or legal entity, other than the depositor, to whom or to which samples of the deposited microorganism were furnished in conformity with Rule 11, on his or its request, together with or at any time after such furnishing of samples.

(b) The viability statement shall indicate whether the microorganism is or is no longer viable and shall contain:

(i) the name and address of the international depositary authority issuing it;

(ii) the name and address of the depositor;

(iii) the date referred to in Rule 7.3(iii) or, where a new deposit or a transfer has been made, the most recent of the dates referred to in Rules 7.4(iii) and 7.5 (iii);

(iv) the accession number given by the said authority;

(v) the date of the test to which it refers;

(vi) information on the conditions under which the viability test has been performed, provided that the said information has been requested by the party at which the viability statement is issued and that the results of the test were negative.

(c) In the cases of paragraph (a) (ii) and (iii), the viability statement shall refer at the most recent viability test.

(d) As to form, languages and signature, Rule 7.2 shall apply, mutatis mutandis, to the viability statement.

(e) In the case of paragraph (a)(I) or where the request is made by an industrial property office, the issuance of the viability statement shall be free of charge. Any fee payable under Rule 12.1 (a)
(iii) in respect of any other viability statement shall be chargeable to the party requesting the statement and shall be paid before or at the time of making the request.