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Japanese to English: 特許共同出願契約書・Joint Application Agreement
Source text - Japanese ００００大学（以下「甲」という。）と００００株式会社（以下「乙」という。）は、甲及び乙が共同でなした発明の特許共同出願並びに甲及び乙が共有する当該発明に係る権利の取扱いについて、次のとおり契約（以下「本契約」という。）を締結するものとする。
・・・
（持分）
第２条 甲及び乙は、本特許権を共有するものとし、その持分は、甲３５％、乙６５％とする。
・・・
（持分の譲渡等）
第７条 甲及び乙は、相手方の書面による事前の承諾なしに、本特許権の自己の持分の一部又は全部を第三者に譲渡し、又はこれを目的として質権を設定してはならない。
・・・
（準用）
第１５条 本契約は、本出願を実用新案登録出願に出願変更した場合、本出願に係る分割出願を行った場合及び本出願に係る国内優先権に基づく出願を行った場合に準用するものとする。
・・・
本契約の締結を証するため、本契約書２通を作成し、甲乙それぞれ１通を保管するものとする。
Translation - English ００００ University (herein referred to as “the First Party”) and ００００ Inc. (herein referred to as “the Second Party”) do hereby agree to the conditions listed in the following agreement (herein referred to as “this Agreement”) regarding joint applications for and ownership rights to inventions created through cooperative research.
・・・
Equity
Article 2: The First and Second Parties agree to share Patent Rights, the First Party retaining 35%, the Second Party 65%.
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Transference of Equity
Article 7: Neither Party may transfer part or all of their Patent Right equity to a third party, nor create a pledge for such a purpose, without the other Party’s written consent.
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Enforcement of Changes
Article 15: This Agreement assumes that any changes made in the Application regarding utility model registration also apply to relative divisional applications and claim of priority applications filed.
・・・
IN WITNESS WHEREOF, the Parties hereto have executed this Agreement in duplicate, and each Party shall keep one copy of the originals.
English to Japanese: 監査報告-Ａｕｄｉｔ Ｒｅｐｏｒｔ
Source text - English Executive Summary: The auditor's overall impression of the site is that the study was conducted under GCP and ICH guidelines. There was one isolated instance of serious GCP non-compliance observed; Subject **** has a Legal Authorized Representative (LAR) because (the subject) had given away (their) power of attorney to (their child) due to memory loss, but the informed consent was signed by the subject instead of (their) LAR. ... In order to determine the significance of this issue and the appropriate actions to be taken, it is suggested that (Company A) consult a regulatory attorney who specialized in Informed Consent violations.
...The site regulatory binder review revealed numerous issuer to be corrected prior to study closure; however, a review of key regulatory documents (e.g. FDA ｆorm 1572, licenses) indicated that all key documents were present and accurate. The site had several issues with outdated or inaccurate information on the staff CV's present in the regulatory binder and there were multiple documents that required PI signature and date that had never been signed. ... The site staff who managed the study, (J) and (S), did an excellent job with source documentation, CRF completion, regulatory document maintenance, providing and documenting informed consent, and overall site management. However, the auditor noted that during the interview with Dr. (D), (Dr. D) was very disconnected from the study; (Dr. D) didn't know how many subjects had been enrolled and was unaware that the site had consented a subject with a LAR.
Translation - Japanese 要旨：監査役が治験施設に関し全体的に受けた印象では、治験自体がGCP及びICH（日米欧医薬品規制ハーモナイゼーション国際会議）基準の下で行なわた。１件の独立した重大なGCP不履行が観察された；被験者番号＊＊＊＊は記憶喪失によって（子供）へ代理権を与えていたのでLAR（法定代理人）がいたにもかかわらず、ICF（インフォームド･コンセント用紙）がLARではなく被験者自身により署名された。...従って当該問題の重要性を判定し、適切な処置を決定するために、（Ａ株式会社）がIC（インフォームド･コンセント）を専門とする規制弁護士と相談することを勧める。
...一方、治験施設の規制バインダーに関し、治験終了前に解決されなければならない複数の問題が明らかになったものの、主要文書（例:FDA用紙1572号、免状など）のレビューが全ての主要文書は揃い、正確だったことを指摘した。但し治験施設の規制バインダーにあったスタッフの経歴書上の情報は無効だったり間違っていたりしていたという問題があり、複数の文書がPIの署名及び日付を必要としていたにもかかわらず署名されていなかった。
...治験を管理した治験施設のスタッフ（ＪさんとＳさん）が原始文書化、CRFの記入、規制文書の管理、インフォームド･コンセント用紙の提供・記録、及び治験施設の全般管理を大変良くできた。一方Ｄ医師は治験からかなり離れていたことを、監査役が医師との面接において注目した。Ｄ医師は何人の被験者が登録されていたかを知らず、治験施設が被験者をLARにより登録したことも認識していなかった。
English to Japanese: Letter to the FDA / FDA宛の文通 General field: Medical Detailed field: Medical: Pharmaceuticals
Source text - English Dear Dr. C:
By this communication, A Inc. (“A.I.”) wishes to inform FDA of the identification of instances of serious breach of compliance with Good Clinical Practices (GCP) in clinical study ****1. During October-November of 2008, A.I. secured the services of an independent GCP compliance auditor to evaluate ****1. The auditor selected two sites from among the United States sites based on pre-established criteria and conducted onsite inspections and interviews with site personnel. The auditor reported to A.I. the following top-line issues from her assessment:
• At one site, it was evident that subjects were not compensated in accordance with the Informed Consent Form (ICF). In addition, there is documentation suggesting that one subject was informed that she would not be compensated for any visits if she did not complete all visits (contrary to the ICF provisions).
• At one site, the ICF on file did not include a three-month follow up visit although subjects returned to the clinic for such visits.
• An ICF for one subject was not signed by the subject's Legal Authorized Representative even though the subject had delegated her power of attorney to a family member.
In addition to these findings, numerous other less serious issues were identified during the audits and are summarized in the full audit reports prepared by the auditor. The audit reports are provided as attachments to this letter.
In addition to the GCP noncompliance findings, significant issues related to the drug product quality were identified in a separate assessment. Specifically, it was discovered that the analytical methods used for release and stability testing of the clinical trial materials used in the two Phase III studies, ****1 and ****2, had not been shown to be stability-indicating or otherwise qualified in any manner. This finding brings into question the purity and potency of the CTM and, therefore, the validity of data collected during these studies.
Based on these issues, A.I. has initiated immediate study close-out for both studies. Since it is evident that the data collected from studies ****1 and ****2 will not be suitable for pivotal study registration, A.I. will perform study close-out according to the abbreviated process described below. The full study close-out procedure is available to FDA upon request. Furthermore, the abbreviated clinical study reports, as described in the close-out procedure which follows, will be submitted to FDA by February 15, 2009.
Study Close-Out Procedure:
All outstanding data queries on safety endpoint data will be resolved; however, queries of non-safety data will not be resolved prior to database lock and study close-out. Only sites with active drug product on-site will have a close-out monitoring visit; sites without drug on-site will have a telephone close-out visit. After database lock, an abbreviated clinical study report will be produced for each study that includes a high-level summary of safety data. Although no formal analyses will be performed, the study reports will include detailed narratives for all serious adverse events and adverse events that led to early discontinuation. Specific details regarding this orderly wind-down of clinical activities will be archived in the Trial Master File for each study.
As a result of the findings from the assessments performed, A.I. requests termination of IND ***** upon submission of the final abbreviated clinical study reports. Soon after that time, A.I. will cease to exist and will not seek to conduct clinical development of study drug D or any other FDA regulated product in the future.
A.I. recognizes the seriousness of noncompliance with the principles of Good Clinical Practice and Good Manufacturing Practice, especially as related to patient safety. By the measures outlined in this communication, A.I. commits to complete and orderly close-out of the clinical studies ****1 and ****2 and the IND under which they were conducted. A.I. welcomes the opportunity to meet with FDA to discuss these findings and our plans for resolution of the issues. If you require additional information of clarification of any of the issues presented herein, please do not hesitate to contact us through our authorized FDA representative, F Inc.
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