BIBLIOGRAPHIC REFERENCES Sample Clauses

BIBLIOGRAPHIC REFERENCES. 1. Directive 2003/94/EC on GMP for Medicinal Products for Human Use.
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BIBLIOGRAPHIC REFERENCES. 1. EU Clinical Trial Directive 2001 / 20 / EC 2. ICH Harmonised Tripartite Guidelines: E6 Guideline for Good Clinical Practice 3. Ipsen Group R&D SOP GCP030 Management of Study Manuals 4. Ipsen Group R&D SOP GCP089 Monitoring of Clinical Trial Sites 5. Ipsen Group R&D SOP GCP090 Close-out of Clinical Trial Sites US INDs —None Other EU CTAs — No EU CTAs. A deposition (notification) for the phase 1 study conducted in 2004 by Ipsen was submitted in Germany January 23 2004 (see attached). The registration number received from the BfArM acknowledging receipt of this deposition was 4021410 (see attached original and English translation). Subsequent correspondence February 26 2004 (see attached) from MDS Pharma Services to the BfArM notified the Authority of BIM44058 Toxicology and Safety Pharmacology studies completed and sponsored by Ipsen Regulatory (market) approvals - None Postanschrift: EINGEGANGEN Xxxx-Xxxxx-Kiesinger-Allee 3 MDS Pharma Services D-53175 Bonn z.Hd. Herrn Xxxxxxx Xxxxx 26. Jan. 2004 Telefon: (0228) 207 - 30 Arnikastr. 4 Telefax: (0228) 207 - 5207 IVBB: 01888 - 307 - 85635 Hohenkirchen e-mail: xxxxxxxxxx@xxxxx.xx Ihre Zeichen und Nachricht vom Gesch.Z.: [ILLEGIBLE] Telefon: (0228) 207- Bonn 7140-00-37/Z 172.10/12 5845 23.01.2004 Ihre Unterlagen vom 15.01.2004 sind am 19.01.2004 bei uns eingegangen: Voriagenummer: 4021410 Name der Studie: 2-52-52127-001 Wir bitten, bei weiteren Einreichungen zu diesem prüfplan sowie bei xxxxx Anzeigen von Verdachtsfällen auf schwerwiegende unerwünschte Arzneimittelwirkungen gemäß § 29 (1) AMG stets die Vorlagenummer anzugèben. Mit freundlichen Grüssen Im Auftrag [ILLEGIBLE] [ILLEGIBLE] Postanschrift: MDS Pharma Services EINGEGANCEN Xxxx-Xxxxx-Kiesinger-Allee 3 Germany GmbH D-53175 Bonn Herrn Xxxxxxx Xxxxx 02. Feb. 2004 Telefon: (01888) - 307 - 0 Arnikastraße 4 (0228) 207 - 30 Telefax: (01888) - 307 - 5207 (0228) 207 - 5207 85635 Höhenkirchen/Siegertsbrunn Nachrichtlich e-mail: xxxxxxxxxx@xxxxx.xx Landesbehörden Bayern / Hamburg vorab per Fax: 08102/4007 Ihre Zelchen and Nachricht xxxx Xxxxx.Z: [ILLEGIBLE] Telefon: (01888) 307- Bonn 15.01. 2004 B VP2. A-7140-00-37/ 4320 29. JAN. 2004 4021410
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BIBLIOGRAPHIC REFERENCES. 19.4.1 Argentina presented to AC8 a proposal on the use of bibliographic references. It informed the meeting that during AC7 Argentina had presented this issue and had announced that it would present a proposal to AC8 (see Annex 11 of AC7 Report). Such proposal had been supported by several Parties. 19.4.2 The issue presented relates to the fact that in meetings of the Agreement documents are often seen using geographic names and other references not necessarily recognised by all Party States. 19.4.3 When it comes to references in the body of documents, the Agreement provides procedures that allow the safeguard of respective national positions if such references might prejudice issues beyond scientific aspects. However, when it comes to citing scientific papers in the references section, such citations may contain geographic names not recognized by some of the State Parties, whose inclusion involuntarily prejudge issues that go beyond scientific rigor. For this, there is no agreed solution under the Agreement or its Rules. 19.4.4 A solution such as removing the citation to the place name not recognized by some of the State Parties would undermine the scientific rigor of the document, since its drafting has used such literature. 19.4.5 In the absence of a specific rule, the Argentinean Delegation submitted for the consideration of the Parties a formula based on publications of the United Nations that could be included as a footnote in the cover page of the documents in question. This would help to ensure the reference to cutting edge scientific documents that provide relevant background to the subject of the Agreement, without any prejudice of the position of the Parties on other issues. 19.4.6 The text of the proposal is as follows: “The bibliographic and documentary references included in this paper have been made for exclusively scientific purposes and do not imply the expression of any opinion whatsoever on the legal status of any country, territory, city or any area, or of its authorities.” 19.4.7 The UK noted that Argentina’s suggestion was unclear in the detail of its application, and that it would be important that Parties were quite clear as to how and when any such new procedure would be applied. Lacking detailed proposals in advance of the meeting the UK considered it was not possible to further consider the proposal at the meeting. 19.4.8 Regarding the concerns expressed by the UK, Argentina noted that the presentation of the topic aimed to comp...
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BIBLIOGRAPHIC REFERENCES. Adamus Resource Assessment, Inc. 1987. Juneau Wetlands Functions and Values. Prepared for the City and Borough of Juneau, Department of Community Development. American Society for Testing and Materials (ASTM). 1999. Standard Guide for Assessment of Wetland Functions. Subcommittee E50.05.
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BIBLIOGRAPHIC REFERENCES. 7.13.1 The MoP agreed that the following disclaimer should be added as a footnote to the cover page of scientific/academic papers that are issued by the Secretariat or its organs, that include reference to disputed territories, and that are authored by entities other than (1) the Secretariat and its organs; (2) the Parties; (3) the non-Party Range States; and (4) observers (e.g. NGOs): ‘Noting Article XIII(1)(c) of the Agreement on the Conservation of Albatrosses and Petrels, the references included in the present document are made exclusively for academic/scientific purposes and have no implications whatsoever for recognition of territorial sovereignty or the legal status of a state, territory, area, or their authorities, where relevant.’
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BIBLIOGRAPHIC REFERENCES. 1. EU Clinical Trial Directive 2001 / 20 / EC 2. ICH Harmonised Tripartite Guidelines: E6 Guideline for Good Clinical Practice
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BIBLIOGRAPHIC REFERENCES. 20.1 Argentina noted the importance of this matter and the support of other delegations for this agenda item in previous meetings. Argentina confirmed that it will submit a paper on this topic to MoP6.
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BIBLIOGRAPHIC REFERENCES. 15.1 The AC Chair informed the meeting that a disclaimer on bibliographic references was agreed at MoP6, and that this footnote had been implemented by the Secretariat for papers submitted to SBWG9 and PaCSWG5. 15.2 Argentina acknowledged that a lot of progress had been made on this and related issues at MoP6, and in general was pleased with the balanced approach achieved. However, it believes that the footnote was intended to not only refer to bibliographic references, but also to any reference or mention of disputed territories elsewhere in the text of the relevant papers. Argentina stated that it would work intersessionally with Parties to resolve any doubt about the application of this disclaimer if the Rules of Procedure allow such an approach. Such consultation with the MoP would be not to modify the text, but rather to clarify the application of the disclaimer.
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Related to BIBLIOGRAPHIC REFERENCES

  • General References All references in this Supplemental Indenture to Articles and Sections, unless otherwise specified, refer to the corresponding Articles and Sections of this Supplemental Indenture; and the term “herein”, “hereof”, “hereunder” and any other word of similar import refers to this Supplemental Indenture.

  • Product References a. “Or Equal” In all Solicitations or Bid Specifications, the words “or equal” are understood to apply where a copyrighted, brand name, trade name, catalog reference, or patented Product is referenced. References to such specific Product are intended as descriptive, not restrictive, unless otherwise stated. Comparable Product will be considered if proof of compatibility is provided, including appropriate catalog excerpts, descriptive literature, specifications and test data, etc. The Commissioner’s decision as to acceptance of the Product as equal shall be final. b. Discrepancies in References In the event of a discrepancy between the model number referenced in the Solicitation or Bid Specifications and the written description of the Products that cannot be reconciled, then the written description shall prevail.

  • Cross-References Unless otherwise specified, references in this Agreement and in each other Loan Document to any Article or Section are references to such Article or Section of this Agreement or such other Loan Document, as the case may be, and, unless otherwise specified, references in any Article, Section or definition to any clause are references to such clause of such Article, Section or definition.

  • Captions and Cross References The various captions (including the table of contents) in this Agreement are provided solely for convenience of reference and shall not affect the meaning or interpretation of any provision of this Agreement. Unless otherwise indicated, references in this Agreement to any Section, Schedule or Exhibit are to such Section Schedule or Exhibit to this Agreement, as the case may be, and references in any Section, subsection, or clause to any subsection, clause or subclause are to such subsection, clause or subclause of such Section, subsection or clause.

  • Tariff References 2.5.1 Wherever any Commission ordered tariff provision or rate is cited or quoted herein, it is understood that said cite encompasses any revisions or modifications to said tariff. 2.5.2 Wherever any Commission ordered tariff provision or rate is incorporated, cited or quoted herein, it is understood that said incorporation or reference applies only to the entity within the state whose Commission ordered that tariff.

  • Headings and Cross-References The various headings in this Agreement are included for convenience only and shall not affect the meaning or interpretation of any provision of this Agreement. References in this Agreement to Section names or numbers are to such Sections of this Agreement.

  • Titles and References All references in this Deposit Agreement to exhibits, articles, sections, subsections, and other subdivisions refer to the exhibits, articles, sections, subsections and other subdivisions of this Deposit Agreement unless expressly provided otherwise. The words "this Deposit Agreement", "herein", "hereof", "hereby", "hereunder", and words of similar import refer to the Deposit Agreement as a whole as in effect between the Company, the Depositary and the Holders and Beneficial Owners of ADSs and not to any particular subdivision unless expressly so limited. Pronouns in masculine, feminine and neuter gender shall be construed to include any other gender, and words in the singular form shall be construed to include the plural and vice versa unless the context otherwise requires. Titles to sections of this Deposit Agreement are included for convenience only and shall be disregarded in construing the language contained in this Deposit Agreement. References to "applicable laws and regulations" shall refer to laws and regulations applicable to ADRs, ADSs or Deposited Securities as in effect at the relevant time of determination, unless otherwise required by law or regulation.

  • Headings; References The article, section and paragraph headings contained in this Agreement are for reference purposes only and shall not affect in any way the meaning or interpretation of this Agreement. All references herein to “Article”, “Sections” or “Exhibits” shall be deemed to be references to Articles or Sections hereof or Exhibits hereto unless otherwise indicated.

  • Monetary References Whenever any amounts of money are referred to herein, such amounts shall be deemed to be in lawful money of Canada unless otherwise expressed.

  • Regulatory References A reference in this Agreement to a section in the HIPAA Rules means the section as in effect or as amended.

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