DEVELOPMENT INFORMATION; ADVERSE REACTIONS; REPORTS Sample Clauses

DEVELOPMENT INFORMATION; ADVERSE REACTIONS; REPORTS. 4.2.1. During the Development Phase and thereafter, each Party shall keep the other informed as to its progress related to Compound MS-325 and Licensed Products developed by either Party or its Affiliates, licensees or sublicensees, including but not limited to any information on adverse reactions and copies of all preclinical or clinical studies or tests performed by such Party. In a timely manner during the Development Phase and thereafter, each Party shall provide the other Party with a reasonably detailed report which shall describe the reporting Party's progress with respect to its development efforts under this Agreement. Each Party will provide the other with a copy of a master dossier as the basis for all submissions to be made by such Party to regulatory authorities on or prior to the date of such submissions as well as promptly provide the results and final reports of all studies and trials conducted by or under the supervision of such Party with respect to Compound MS-325 and Licensed Products. Each Party will have the right to use all such information received from the other Party, subject to the confidentiality provisions of Article 10. Within thirty (30) days after the end of each calendar quarter during the Development Phase with respect to Compound MS-325 and corresponding Licensed Products, each Party shall provide the other Party with a reasonably detailed report which shall describe the reporting Party's progress with respect to its objectives and responsibilities under the Development Plan. 4.2.2. Promptly following the execution of this Agreement, the Parties will draft and adopt standard operating procedures to govern the investigation of and action to be taken with regard to Licensed Product-related adverse drug experience reports (from both clinical studies and marketing experience), quality reports and complaints, such that each of the Parties can comply with its legal obligations worldwide. The standard operating procedures will be promptly amended as changes in legal obligations require or as otherwise agreed to by the Parties.
Sample 1
AutoNDA by SimpleDocs

Related to DEVELOPMENT INFORMATION; ADVERSE REACTIONS; REPORTS

  • Development Reports Beginning six months after Effective Date and ending on the date of first commercial sale of a Licensed Product in the United States, LICENSEE shall report to Cornell progress covering LICENSEE's (and Affiliate's and Sublicensee's) activities and efforts in the development of rights granted to LICENSEE under this Agreement for the preceding six months. The report shall include, but not be limited to, activities and efforts to develop and test all Licensed Products and obtain governmental approvals necessary for marketing the same. Such semi-annual reports shall be due within sixty days (60) of the reporting period and shall use the form as provided herein as Appendix C.

  • Adverse Event Reporting Both Parties acknowledge the obligation to comply with the Protocol and / or applicable regulations governing the collection and reporting of adverse events of which they may become aware during the course of the Clinical Trial. Both Parties agree to fulfil and ensure that their Agents fulfil regulatory requirements with respect to the reporting of adverse events.

  • Patient Information Each Party agrees to abide by all laws, rules, regulations, and orders of all applicable supranational, national, federal, state, provincial, and local governmental entities concerning the confidentiality or protection of patient identifiable information and/or patients’ protected health information, as defined by any other applicable legislation in the course of their performance under this Agreement.

  • Line Information Database LIDB is a transaction-oriented database accessible through Common Channel Signaling (CCS) networks. For access to LIDB, ONS must purchase appropriate signaling links pursuant to Section 10 of this Attachment. LIDB contains records associated with End User Line Numbers and Special Billing Numbers. LIDB accepts queries from other Network Elements and provides appropriate responses. The query originator need not be the owner of LIDB data. LIDB queries include functions such as screening billed numbers that provides the ability to accept Collect or Third Number Billing calls and validation of Telephone Line Number based non-proprietary calling cards. The interface for the LIDB functionality is the interface between BellSouth’s CCS network and other CCS networks. LIDB also interfaces to administrative systems.

  • Adverse Events Subsequent to the date hereof, there shall not have occurred any of the following: (i) a suspension or material limitation in trading in securities generally on the New York Stock Exchange, the NASDAQ National Market or the NASDAQ Global Market, (ii) a general moratorium on commercial banking activities in the People’s Republic of China or New York, (iii) the outbreak or escalation of hostilities involving the United States or the People’s Republic of China or the declaration by the United States or the People’s Republic of China of a national emergency or war if the effect of any such event specified in this clause (iii) in your reasonable judgment makes it impracticable or inadvisable to proceed with the public offering or the delivery of the Shares on the terms and in the manner contemplated in the Prospectus, or (iv) such a material adverse change in general economic, political, financial or international conditions affecting financial markets in the United States or the People’s Republic of China having a material adverse impact on trading prices of securities in general, as, in your reasonable judgment, makes it impracticable or inadvisable to proceed with the public offering of the Shares or the delivery of the Shares on the terms and in the manner contemplated in the Prospectus.

  • Project Information Except for confidential information designated by the City as information not to be shared, Consultant agrees to share Project information with, and to fully cooperate with, those corporations, firms, contractors, public utilities, governmental entities, and persons involved in or associated with the Project. No information, news, or press releases related to the Project, whether made to representatives of newspapers, magazines, or television and radio stations, shall be made without the written authorization of the City’s Project Manager.

  • Commercialization Reports Throughout the term of this Agreement and during the Sell-Off Period, and within thirty (30) days of December 31st of each year, Company will deliver to University written reports of Company’s and Sublicensees’ efforts and plans to develop and commercialize the innovations covered by the Licensed Rights and to make and sell Licensed Products. Company will have no obligation to prepare commercialization reports in years where (a) Company delivers to University a written Sales Report with active sales, and (b) Company has fulfilled all Performance Milestones. In relation to each of the Performance Milestones each commercialization report will include sufficient information to demonstrate achievement of those Performance Milestones and will set out timeframes and plans for achieving those Performance Milestones which have not yet been met.

  • Event Information Number: 230202 Addendum 1 Title: Security Systems Products and Services Type: Request for Proposal Issue Date: 2/2/2023 Deadline: 3/17/2023 03:00 PM (CT) Notes: This is a solicitation issued by The Interlocal Purchasing System (TIPS), a department of Texas Region 8 Education Service Center. It is an Indefinite Delivery, Indefinite Quantity ("IDIQ") solicitation. It will result in contracts that provide, through adoption/"piggyback" an indefinite quantity of supplies/services, during a fixed period of time, to TIPS public entity and qualifying non-profit "TIPS Members" throughout the nation. Thus, there is no specific project or scope of work to review. Rather this solicitation is issued as a prospective award for utilization when any TIPS Member needs the goods or services offered during the life of the agreement. IF YOU CURRENTLY HOLDS TIPS CONTRACT 200203 SECURITY SYSTEMS PRODUCTS AND SERVICES ("200203"). YOU MUST RESPOND TO THIS SOLICITATION TO PREVENT LAPSE OF CONTRACT UNLESS YOU HOLD ANOTHER CURRENT TIPS CONTRACT THAT COVERS ALL OF YOUR SECURITY OFFERINGS. THIS AWARDED CONTRACT WILL REPLACE YOUR EXPIRING TIPS CONTRACT 200203. Address: Region 8 Education Service Center 0000 XX Xxxxxxx 000 Xxxxx Pittsburg, TX 75686 Phone: +0 (000) 000-0000 Email: xxxx@xxxx-xxx.xxx Contact: Xxxxxx Xxxxxxx Address: 000 - 00000 Xxxxx Xxx. Abbotsford, BC V2T6H1 Canada Phone: (000) 000-0000 Fax: (000) 000-0000 Toll Free: (000) 000-0000 Email: xxxxxxxxx@xxxxxxxxxx-xxxxxxx.xxx Web Address: xxx.xxxxxxxxxx-xxxxxxx.xxx By submitting your response, you certify that you are authorized to represent and bind your company. Pricing Form 1 must be downloaded from the “Attachments” section of the IonWave eBid System, reviewed, properly completed as instructed, and uploaded to this location. Pricing Form 2 must be downloaded from the “Attachments” section of the IonWave eBid System, reviewed, properly completed as instructed, and uploaded to this location.

  • Client Information Protected Health Information in any form including without limitation, Electronic Protected Health Information or Unsecured Protected Health Information (herein “PHI”);

  • Regulatory Information (a) All the notaries at De Pinna LLP are regulated through the Faculty Office of the Archbishop of Canterbury. Its address is The Faculty Office, 0 Xxx Xxxxxxxxx, Xxxxxxxxxxx, Xxxxxx XX0X 0XX, its telephone: 000 0000 0000, and it can be reached by email at xxxxxxx.xxxxxx@0xxxxxxxxxxxx.xxx. It also has a website at xxx.xxxxxxxxxxxxx.xxx.xx. (b) We are required to comply with the rules of professional conduct and other regulatory arrangements of the Master of the Faculties, the sole regulator of notarial activities under the Legal Services Act 2007. Information about those rules and regulations may be found at xxxx://xxx.xxxxxxxxxxxxx.xxx.xx/notary/i-am-a-notary/notaries-rules-regulations/. (c) We comply with the Code of Practice published by the Master of the Faculties: xxxx://xxx.xxxxxxxxxxxxx.xxx.xx/notary/code-of-practice.

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!