Subsection F. PROTECTION OF TEST DATA
Article 10.33. Protection of Test Data Submitted to Obtain an Administrative Marketing Approval to Put a Pharmaceutical Product on the Market
Where a Party requires the submission of test data or studies concerning the safety and efficacy of a pharmaceutical product prior to granting approval for the marketing of such product, that Party shall not, for a period of at least five years from the date of approval in that Party, permit third parties to market the same or a similar product on the basis of the marketing approval granted to the party which had provided the test data or studies, unless that party has given its consent (61) (62) (63).
Article 10.34. Protection of Test Data Submitted to Obtain an Administrative Marketing Approval to Put an Agricultural Chemical Product on the Market (64)
1. Where a Party requires the submission of test data or studies concerning the safety and efficacy of an agricultural chemical product prior to the granting of approval for the marketing of such product in that Party, the Party shall not, for a period of at least ten years from the date of approval, permit third parties to market the same or a similar product on the basis of the marketing approval granted to the party which had provided the test data or studies, unless that party has given its consent.
2. Where a Party provides for measures or procedures to avoid duplicative testing on vertebrate animals with respect to agricultural chemical products, that Party may provide for the conditions and circumstances under which third parties may market the same or similar product on the basis of the marketing approval granted to the party which had provided the test data or studies.
3. Where a Party requires the submission of test data or studies concerning the safety or efficacy of an agricultural chemical product prior to the granting of an approval for the marketing of such product, that Party shall endeavour to make best efforts to process the application expeditiously, with a view to avoiding unreasonable delays.
Subsection G. PLANT VARIETIES
Article 10.35. International Agreements
The Parties affirm their obligations under the International Convention for the Protection of New Varieties of Plants adopted in Paris on 2 December 1961, as last revised in Geneva on 19 March 1991, including their ability to imple- ment the optional exception to the breeder's right, as referred to in paragraph 2 of Article 15 of that Convention.
Section C. CIVIL ENFORCEMENT OF INTELLECTUAL PROPERTY RIGHTS
Article 10.36. General Obligations
1. The Parties affirm their commitments under Articles 41 to 50 of the TRIPS Agreement, and shall provide for the measures, procedures and remedies under their respective domestic law against acts of infringement of intellectual property rights covered by this Chapter, that are in compliance with such commitments.
2. In particular, the measures, procedures and remedies referred to in paragraph 1, and provided for by each Party under its domestic law, shall:
(a) take into account, as appropriate, the need for proportionality between the seriousness of the infringement and the interests of third parties;
(b) be fair and equitable;
(c) not be unnecessarily complicated or costly, or entail unreasonable time limits or unwarranted delays; and
(d) be applied in such a manner as to avoid the creation of barriers to legitimate trade and to provide for safeguards against their abuse.
3. Nothing in this Chapter shall affect the capacity of either Party to enforce its domestic law in general or create any obligation on either Party to amend its existing laws as they relate to the enforcement of intellectual property rights. Without prejudice to the foregoing general principles, nothing in this Chapter shall create any obligation on either Party:
(a) to put in place a judicial system for the enforcement of intellectual property rights that is distinct from that for the enforcement of law in general; or
(b) with respect to the distribution of resources as between the enforcement of intellectual property rights and the enforcement of law in general.
Article 10.37. Publication of Judicial Decisions
In civil judicial proceedings instituted for infringement of an intellectual property right, each Party shall take appropriate measures, pursuant to its domestic law and policies, to publish or make available to the public information on final judicial decisions. Nothing in this Article shall require a Party to disclose confidential information, the disclosure of which would impede law enforcement or otherwise be contrary to the public interest or would prejudice the legitimate commercial interests of particular enterprises, public or private. Each Party may provide for other additional publicity measures which are appropriate to the particular circumstances, including prominent advertising.
Article 10.38. Availability of Civil Measures, Procedures and Remedies
1. Each Party shall make available, in its respective domestic law and to right holders, the civil measures, procedures and remedies referred to in Section C (Civil Enforcement of Intellectual Property Rights) for the intellectual property rights as defined in paragraph 2.
2. For the purposes of Section C (Civil Enforcement of Intellectual Property Rights), the following terms have the following meanings:
(a) "right holders" shall include exclusive licensees as well as federations and associations (65) having the legal standing to assert such rights; and
(b) "intellectual property rights" means all categories of intellectual property that are the subject of Sections 1 to 6 of Part Il of the TRIPS Agreement (66).
Article 10.39. Measures for Preserving Evidence
1. Each Party shall provide that its judicial authorities have the authority to order prompt and effective provisional measures:
(a) against a party or, where appropriate, a third party over whom the relevant judicial authority exercises jurisdiction, to prevent an infringement of any intellectual property right from occurring, and in particular to prevent goods that involve the infringement of an intellectual property right from entering into the channels of commerce; and
(b) to preserve relevant evidence in regard to the alleged infringement.
2. Each Party shall provide that its judicial authorities have the authority to adopt provisional measures inaudita altera parte where appropriate, in particular where any delay is likely to cause irreparable harm to the right holder or where there is a demonstrable risk of evidence being destroyed. In proceedings conducted inaudita altera parte, each Party shall provide its judicial authorities with the authority to act expeditiously on requests for provisional measures and to make a decision without undue delay.
3. At least in cases of copyright or related rights infringement and in cases of trademark counterfeiting, each Party shall provide that in civil judicial proceedings, its judicial authorities, have the authority to order the seizure or taking into custody of suspect goods, of materials and implements relevant to the act of infringement, and, at least for trademark counterfeiting, of documentary evidence, either original or copies thereof, relevant to the infringement.
4. Each Party shall provide that its authorities have the authority to require the applicant, with respect to provisional measures, to provide any reasonably available evidence in order to satisfy themselves with a sufficient degree of certainty that the applicant's right is being infringed or that such infringement is imminent, and to order the applicant to provide a security or equivalent assurance sufficient to protect the defendant and to prevent abuse. Such security or equivalent assurance shall not unreasonably deter recourse to procedures for such provisional measures.
5. Where the provisional measures are revoked, or where they lapse due to any act or omission by the applicant, or where it is subsequently found that there has been no infringement of an intellectual property right, the judicial authorities shall have the authority to order the applicant, upon the request of the defendant, to provide the defendant appropriate compensation for any injury caused by those measures.
Article 10.40. Evidence and Right of Information
1. Without prejudice to each Party's domestic law governing privilege, the protection of confidentiality or the pro-cessing of personal data, each Party shall provide that, in civil judicial proceedings concerning the enforcement of intellectual property rights, its judicial authorities have the authority, upon a justified request of the right holder, to order the infringer or, in the alternative, the alleged infringer, to provide, to the right holder or to the judicial authorities, at least for the purpose of collecting evidence, relevant information as provided for in its applicable laws and regulations that the infringer or alleged infringer possesses or controls.
2. The relevant information referred to in paragraph 1 may include information regarding any person involved in any aspect of the infringement or alleged infringement and regarding the means of production or the channels of distri- bution of the infringing or allegedly infringing goods or services, including the identification of third persons alleged to be involved in the production and distribution of such goods or services and of their channels of distribution.
Article 10.41. Other Remedies
1. Each Party shall provide that, in civil judicial proceedings where a judicial decision is taken finding an infringement of a right holder's intellectual property right, its judicial authorities shall, upon application by the right holder, have the authority, at least with respect to pirated copyright goods and counterfeit trademark goods, to order:
(a) that such infringing goods, without compensation of any sort, be:
(i) destroyed, except in exceptional circumstances; or
(ii) disposed of outside the channels of commerce in such a manner as to avoid any harm caused to the right holder; and
(b) that materials and implements, the predominant use of which has been in the manufacture or creation of such infringing goods, shall be, without undue delay and without compensation of any sort, destroyed or disposed of outside the channels of commerce in such a manner as to minimise the risks of further infringements.
2. In considering any application by a right holder, as referred to in paragraph 1, the need for proportionality between the seriousness of the infringement and the remedies ordered as well as the interests of third parties shall be taken into account.
3. The remedies under this Article may be carried out at the expense of the infringer.
Article 10.42. Injunctions
Each Party shall provide that, in civil judicial proceedings where a judicial decision is taken finding an infringement of a right holder's intellectual property right, its judicial authorities shall, upon application by the right holder, have the authority to issue against the infringer or, where appropriate, against a third party over whom the relevant judicial authority exercises jurisdiction, an injunction aimed at prohibiting the continuation of the infringement. Where provided for by the Party's domestic law, non-compliance with an injunction shall, where appropriate, be subject to a recurring penalty payment with a view to ensuring compliance.
Article 10.43. Alternative Measures
Each Party may provide in its domestic law that, in civil judicial proceedings where a judicial decision is taken finding an infringement of a right holder's intellectual property right, in appropriate cases and on application by the person liable to be subject to the measures provided for in Article 10.41 (Other Remedies) and/or Article 10.42 (Injunctions), its judicial authorities have the authority to order pecuniary compensation to be paid to the injured party instead of applying the measures provided for in Article 10.41 (Other Remedies) and/or Article 10.42 (Injunctions), provided that the applicant acted unintentionally and without negligence, the execution of the measures in question would cause disproportionate harm to the applicant, and pecuniary compensation to the injured party appears reasonably satisfactory (67).
Article 10.44. Damages
1. Each Party shall provide that, in civil judicial proceedings concerning the enforcement of intellectual property rights, its judicial authorities have the authority to order the infringer who, knowingly or with reasonable grounds to know, engaged in infringing activity to pay the right holder damages adequate to compensate for the injury the right holder has suffered as a result of the infringement.
2. In determining the amount of damages for infringement of intellectual property rights, a Party's judicial authorities shall have the authority to consider, inter alia, any legitimate measure of value the right holder submits, which may include lost profits, the value of the infringed goods or services measured by the market price, or the suggested retail price (68). At least in cases of copyright or related rights infringement and trademark counterfeiting, each Party shall provide that its judicial authorities have the authority to order the infringer to pay the right holder the infringer's profits that are attributable to the infringement, whether as an alternative to or in addition to or as part of the damages.
3. As an alternative to paragraph 2, each Party may provide that its judicial authorities have the authority, in appropriate cases, to set the damages as a lump sum on the basis of elements such as at least the amount of royalties or fees which would have been due if the infringer had requested authorisation to use the intellectual property right in question.
4. Nothing in this Article precludes either Party from providing that where the infringer did not knowingly, or with reasonable grounds to know, engage in infringing activity, its judicial authorities may order the recovery of profits or the payment of damages which may be pre-established.
Article 10.45. Legal Costs
Each Party shall provide that its judicial authorities, where appropriate, have the authority to order, at the conclusion of civil judicial proceedings concerning infringement of intellectual property rights, that the prevailing party be awarded payment by the losing party of court costs or fees and appropriate attorney's fees, or any other expenses as provided for under that Party's domestic law.
Article 10.46. Presumptions Relating to Copyright and Related Rights
In civil proceedings involving copyright or related rights, each Party shall provide for a presumption that, at least with respect to a literary or artistic work, performance or phonogram, in the absence of proof to the contrary, the natural or legal person whose name appears on such work, performance or phonogram in the usual manner, is the right holder and is consequently entitled to institute infringement proceedings.
Article 10.47. Liability of Intermediary Service Providers
1. Subject to paragraphs 2 to 6, each Party shall provide for exemptions or limitations in its domestic law regarding the liability of, or scope of remedies available against, service providers for infringements of copyright or related rights or trademarks that take place through systems or networks controlled or operated by them or on their behalf.
2. The exemptions or limitations referred to in paragraph 1:
(a) shall cover the functions of:
(i) transmitting (69), or providing access for material without selection and/or modification of its content (70); and
(ii) caching carried out through an automatic process (71); and
(b) may also cover the functions of:
(i) storage at the direction of a user of material residing on a system or network controlled or operated by or for the service provider; and
(ii) referring or linking users to an online location by using information location tools, including hyperlinks and directories.
3. Eligibility for the exemptions or limitations in this Article may not be conditioned on the service provider monitoring its service, or affirmatively seeking facts indicating infringing activity, except to the extent consistent with such technical measures.
4. Each Party may prescribe in its domestic law, conditions for service providers to qualify for the exemptions or limitations in this Article. Without prejudice to paragraphs 1 to 3, each Party may establish appropriate procedures for effective notifications of claimed infringement and effective counter-notifications by those whose material is removed. or disabled through mistake or misidentification.
5. This Article is without prejudice to the availability of defences to the infringement of copyright or related rights, or trademarks, that are of general applicability. This Article shall not affect the possibility of the court or administrative authority of a Party, in accordance with its legal system, requiring the service provider to terminate or prevent an infringement.
6. Either Party may request consultations with the other Party to consider how to address future functions of a nature similar to those addressed in this Article.
Section D. BORDER MEASURES
Article 10.48. Definitions
For the purposes of this Section:
(a) "counterfeit geographical indication goods" means any goods, including packaging, bearing, without authorisation, a sign which is identical to the geographical indication validly registered in respect of such goods in the territory where the goods are, or which cannot be distinguished in its essential aspects from such a geographical indication and which thereby infringes the rights of the owner or holder of the geographical indication in question under the domestic law of the Party where the goods are;
(b) "counterfeit trademark goods" means any goods, including packaging bearing, without authorisation, a trademark which is identical to the trademark validly registered in respect of such goods, or which cannot be distinguished in its essential aspects from such a trademark and which thereby infringes the rights of the owner of the trademark in question under the domestic law of the Party where the goods are;
(c) "goods in transit" means goods the passage of which across the territory of a Party, with or without transhipment, whether or not landed in the territory of the Party, warehousing, breaking bulk, or change in the mode of transport or conveyance, is only a portion of a complete journey beginning and terminating beyond the frontier of the Party across which territory the traffic passes;
(d) "pirated copyright goods" means any goods which are copies made without the consent of the right holder or of a person duly authorised by the right holder in the country of production, and which are made directly or indirectly from an article where the making of that copy would have constituted an infringement of a copyright or a related right under the domestic law of the Party where the goods are; and
(e) "pirated design goods" means any goods in respect of which the design is registered and to which that design or a design not substantially different from it has been applied without the consent of the right holder or of a person duly authorised by the right holder in the country of production, where the making of those goods would have constituted an infringement under the domestic law of the Party where the goods are.
Article 10.49. Scope of Border Measures
1. Without prejudice to paragraph 3, each Party shall adopt or maintain procedures with respect to goods under customs control under which a right holder may request its competent authorities to suspend the release of suspect:
(a) counterfeit trademark goods;
(b) pirated copyright goods;
(c) counterfeit geographical indication goods; and
(d) pirated design goods.
2. Each Party shall adopt or maintain procedures with respect to goods under customs control, under which its competent authorities may act upon their own initiative to suspend the release of suspect (72):
(a) counterfeit trademark goods;
(b) pirated copyright goods; and
(c) counterfeit geographical indication goods.
3. The Parties shall not have the obligation to provide for the procedures referred to in paragraphs 1 and 2 with regards to goods in transit. This is without prejudice to paragraph 2 of Article 10.51 (Cooperation).
4. Singapore shall fully implement the obligations of paragraphs 1 and 2 ideally within two but no later than three years of the entry into force of this Agreement with regard to procedures with respect to:
(a) counterfeit geographical indication goods; and
(b) pirated design goods.
Article 10.50. Identification of Shipments
To facilitate the effective enforcement of intellectual property rights, the customs authorities shall adopt a range of approaches to identify shipments containing counterfeit trademark goods, pirated copyright goods, pirated design goods, and counterfeit geographical indication goods. These approaches include risk analysis techniques based, inter alia, on information provided by right holders, intelligence gathered and cargo inspections.
Article 10.51. Cooperation
1. The Parties agree to cooperate with a view to eliminating international trade in goods that infringe intellectual property rights. For this purpose, they shall, in particular, exchange information and arrange for cooperation, to be mutually agreed between their customs authorities, with regard to trade in counterfeit trademark goods, pirated copy- right goods, pirated design goods, or counterfeit geographical indication goods.
2. For shipments of goods transiting or transhipped through the territory of a Party and destined for the territory of the other Party, which are suspected of being counterfeit or pirated, the Parties shall, upon their own initiative or upon the request of the other Party, provide available information to the other Party to enable effective enforcement against those shipments. The Parties may not provide information which is submitted confidentially by the shipper, shipping line or its agent.
() The Parties will review the possibility of including pirated design goods within the scope of paragraph 2 of this Article within three years of the entry into force of this Agreement. The Parties may, by decision in the Trade Committee, amend paragraph 2 of this Arti- cle as a result of such review.
Section E. COOPERATION
Article 10.52. Cooperation
1. The Parties agree to cooperate with a view to supporting the implementation of the commitments and obligations undertaken under this Chapter. Areas of cooperation include, but are not limited to, the following activities:
(a) exchange of information on legal frameworks concerning intellectual property rights, including implementation of intellectual property legislation and systems, aimed at promoting the efficient registration of intellectual property rights;
(b) exchange, between respective authorities responsible for the enforcement of intellectual property rights, of their experiences and best practices concerning enforcement of intellectual property rights;
(c) exchange of information and cooperation on public outreach and appropriate initiatives to promote awareness of the benefits of intellectual property rights and. systems;
(d) capacity-building and technical cooperation in relation, but not limited, to: management, licensing, valuation and exploitation of intellectual property rights; technology and market intelligence; facilitation of industry collaborations, including on intellectual property rights that may be applied towards environmental conservation or enhancement, which may include establishing a platform or database; and public private partnerships to support culture and innovation;
(e) exchange of information and cooperation on intellectual property issues, where appropriate and relevant to developments in environmentally friendly technology; and
(f) any other areas of cooperation or activities as may be discussed and agreed between the Parties.
2. Without prejudice to paragraph 1, the Parties agree to designate a contact point for the purpose of maintaining dialogue including, where useful, convening meetings on intellectual property issues between their respective technical experts on matters covered by this Chapter.
3. Cooperation under this Article shall be carried out subject to each Party's laws, rules, regulations, directives or policies. Cooperation shall also be on mutually agreed terms and conditions and be subject to the availability of resources of each Party.
Chapter ELEVEN. COMPETITION AND RELATED MATTERS
Section A. ANTI-COMPETITIVE CONDUCT AND MERGERS
Article 11.1. Principles
1. The Parties recognise the importance of free and undistorted competition in their trade relations. They acknowledge that anti-competitive business conduct and anti-competitive transactions have the potential to distort the proper functioning of their markets and undermine the benefits of trade liberalisation.
2. To promote free and undistorted competition in all sectors of their economy, each Party shall maintain in its respective territory comprehensive legislation which effectively addresses the following practices, where such practices affect trade between the Parties:
(a) horizontal and vertical agreements (73) between undertakings, decisions by associations of undertakings, and concerted practices, which have as their object or effect the prevention, restriction or distortion of competition in the territory of either Party as a whole or in a substantial part thereof;
(b) abuses by one or more undertakings of a dominant position in the territory of either Party as a whole or in a substantial part thereof; and
(c) concentrations between undertakings which result in a substantial lessening of competition or which significantly impede effective competition, in particular as a result of the creation or strengthening of a dominant position in the territory of either Party as a whole or in a substantial part thereof.
Article 11.2. Implementation
1. Each Party shall maintain its autonomy in developing and enforcing its law. The Parties undertake, however, to maintain authorities that are responsible for, and appropriately equipped to effectively enforce the legislation referred to in paragraph 2 of Article 11.1 (Principles).
2. The Parties will apply their respective legislation referred to in paragraph 2 of Article 11.1 (Principles) in a transparent and non-discriminatory manner, respecting the principles of procedural fairness and the rights of defence of the parties concerned, including the right of the parties concerned to be heard prior to the taking of a decision in a case.
Section B. PUBLIC UNDERTAKINGS, UNDERTAKINGS ENTRUSTED WITH SPECIAL OR EXCLUSIVE RIGHTS AND STATE MONOPOLIES
Article 11.3. Public Undertakings and Undertakings Entrusted with Special or Exclusive Rights
1. Nothing in this Chapter prevents a Party from establishing or maintaining public undertakings, or entrusting undertakings with special or exclusive rights according to its respective law.
2. Each Party shall ensure that public undertakings and undertakings that are entrusted with special or exclusive rights are subject to the legislation referred to in Section A (Anti-Competitive Conduct and Mergers), insofar as the application of such rules does not obstruct the performance, in law or in fact, of the particular tasks assigned to them.
3. Each Party shall ensure that undertakings entrusted with special or exclusive rights do not use those special or exclusive rights to engage either directly or indirectly, including through their dealings with their parents, subsidiaries, or other undertakings with common ownership, in anti-competitive practices in another market in respect of which such undertakings have no special or exclusive rights, that adversely affect investments, trade in goods or services of the other Party.
4. Singapore shall ensure that any public undertaking and any undertaking entrusted with special or exclusive rights acts solely in accordance with commercial considerations in its purchase or sale of goods or services, such as with regard to price, quality, availability, marketability, transportation, and other terms and conditions of purchase or sale, and provides non-discriminatory treatment to establishments of the Union, to goods of the Union, and to service suppliers of the Union.
Article 11.4. State Monopolies
While nothing in this Chapter shall be construed to prevent a Party from designating or maintaining state monopolies, each Party shall adjust state monopolies of a commercial character to ensure no discrimination is exercised by such monopolies regarding the conditions under which goods and services are procured from and marketed to natural or legal persons of the other Party.
Section C. SUBSIDIES
Article 11.5. Definition and Scope
1. For the purposes of this Agreement, a subsidy is a measure which fulfils the conditions set out in Article 1.1 of the SCM Agreement, mutatis mutandis, irrespective of whether the subsidy is granted in relation to the production of goods or of services (74).
2. Subsidies shall be subject to this Chapter only if they are specific, within the meaning of Article 2 of the SCM Agreement. Any subsidy falling under Article 11.7 (Prohibited Subsidies) shall be deemed to be specific.
3. Articles 11.7 (Prohibited Subsidies), 11.8 (Other Subsidies) and 11.10 (Review Clause) and Annex 11-A shall not apply to fisheries subsidies, subsidies related to products covered by Annex 1 of the Agreement on Agriculture and other subsidies covered by the Agreement on Agriculture.