Page:United States Statutes at Large Volume 105 Part 3.djvu/714

 105 STAT. 2598 PROCLAMATION 6307—JUNE 24, 1991 (2] Unless the national or company submitting the information agrees, the data may not be relied upon for the approval of competing products for a reasonable period of time, taking into account the efforts involved in the origination of the data, their nature, and the expenditure involved in their preparation, and such period of time shall generally be not less than five years from the date of marketing approval. (3) Where a Party relies upon a marketing approval granted by the other Party or a country other than the United States or Bulgaria, the reasonable period of exclusive use of the data submitted in connection with obtaining the approval relied upon shall commence with the date of the first marketing approval relied upon. (f) Enforcement of Intellectual Property Rights (i) Each Party shall protect intellectual property rights covered by this letter by means of civil law, criminal law, or administrative law or a combination thereof in conformity with the provisions below. Each Party shall provide effective procedures, internally and at the border, to protect these intellectual property rights against any act of infringement, and effective remedies to stop and prevent infringements and to effectively deter further infringements. These procedures shall be applied in such a manner as to avoid the creation of obstacles to legitimate trade and provide for safeguards against abuse. (ii) Procedures concerning the enforcement of intellectual property rights shall be fair and equitable. (iii) Decisions on the merits of a case shall, as a general rule, be in writing and reasoned. They shall be made known at least to the parties to the dispute without undue delay. (iv) Each Party shall provide an opportunity for judicial review of final administrative decisions on the merits of an action concerning the protection of an intellectual property right. Subject to jurisdictional provisions in national laws concerning the importance of a case, an opportunity for judicial review of the legal aspects of initial judicial decisions on the merits of a case concerning the protection of an intellectual property right shall also be provided. (v) Remedies against a Party Notwithstanding the other provisions of paragraph 2(f), when a Party is sued for infringement of an intellectual property right as a restdt of the use of that right by or for the government, the Party may limit remedies against the government to payment of full compensation to the right-holder. 3. Each Party agrees to submit for enactment, no later than December 31, 1992, the legislation necessary to carry out the obligations of this letter and to exert its best efforts to enact and implement this legislation by that date. 4. For piu^oses of this letter: (a) "right-holder," means the right-holder himself, any other natural or legal person authorized by him who are exclusive licensees of the right, or other authorized persons, including federations and associations, having legal standing under domestic law to assert such rights;

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