Recording Adverse Events and Serious Adverse Events Sample Clauses

Recording Adverse Events and Serious Adverse Events. Adverse events (AEs), including those attributed to study procedures, will be documented on the AE eCRF and monitored continuously throughout the study from the time of informed consent until 30 days after the patient’s last study treatment. Only AEs/SAEs which are considered related to a study procedure (ie blood draw or fresh tumor biopsy) will be captured during the pre-screening period, ie from the time of signing of the pre- screening informed consent (if one is utilized) until the time of signing of the main study informed consent, or until the patient is determined to be a screen failure. All AEs and SAEs, regardless of causality, will be captured after the main study ICF has been signed. In patients receiving MIRV, all ocular AEs will be followed until resolution, stabilization, or return to baseline. SAEs will be followed up by ImmunoGen Pharmacovigilance until resolution, stabilization or return to baseline. Beyond this defined reporting period, any unsolicited SAE assessed as related to the study drug by the Investigator and reported to ImmunoGen will be collected and processed. Additional information obtained after database lock, will reside solely in the safety database. The Investigator should follow and provide updates for all AEs until clinical recovery is complete, laboratory values return to normal, the patient stabilizes, or death occurs, to ensure the safety of the patients. This may mean that observations continue beyond the last planned visit per protocol and that additional investigations may be requested by the Sponsor.
Sample 1
AutoNDA by SimpleDocs

Related to Recording Adverse Events and Serious Adverse Events

  • Confidential Information “Confidential Information” shall mean (i) Highly Confidential Information (as defined below), (ii) any other technology, software development tools, methodologies, processes, algorithms, test data sets and test data cases and related documentation that CI Plus LLP provides to Licensee hereunder in order to facilitate Licensee’s exercise of its rights and performance of its obligations hereunder, and (iii) any other information of CI Plus LLP and information of Licensee, each of which is clearly marked as “Confidential” or a similar expression when disclosed in written or electronic form, or indicated as “Confidential” when disclosed orally and confirmed in writing within thirty (30) calendar days after such disclosure. “Confidential Information” shall not include information which: (a) was in the possession of, or was known by, the receiving party ("Recipient") prior to its receipt from the disclosing party (“Discloser), without an obligation owed to Discloser, or its licensors, to maintain its confidentiality; (b) is or becomes generally known to the public without violation of this Agreement by the “Recipient”; (c) is obtained by Recipient from a third party, without an obligation owed to such third party to keep such information confidential; or (d) is independently developed by Recipient without use of any Confidential Information of the other party. Recipient agrees that it shall use reasonable care to keep the Confidential Information of the other party strictly confidential and not disclose it to any other person except to its Affiliates and its and their respective employees, contractors, consultants, agents, customers and representatives (other than Members) who have a “need to know” for the purposes of this Agreement and are obligated by Licensee to be bound by the same confidentiality obligation which Recipient is bound by under this Exhibit H, provided however that Recipient may disclose Highly Confidential Information only in accordance with Section 2 of this Exhibit H. Recipient shall be responsible for any breach of such confidentiality obligation by such parties, including former employees, Affiliates, contractors, consultants, agents, customers (other than Members) and representatives. Recipient shall protect the Confidential Information of the other party with the same degree of care as it normally uses in the protection of its own similar confidential and proprietary information, but in no case with any less than reasonable care. Notwithstanding anything in this Exhibit H to the contrary, Confidential Information may be disclosed by Recipient pursuant to the order or requirements of a court or governmental administrative agency or other governmental body of competent jurisdiction, provided that (x) Discloser has been notified of such a disclosure request immediately after Recipient knows such order or requirements in order to afford Discloser reasonable opportunity to obtain a protective order or otherwise prevent or limit the scope of such disclosure to the extent permitted by law and (y) Recipient cooperates in good faith with such efforts by Discloser. The obligations under this Exhibit H shall terminate three years after the date of the last shipment of product using the Licensed Technology by Licensee or any other licensee of the Licensed Technology; provided that Sections 2.0(b), 2.0(c), and 3.0 in this Exhibit H shall cease to apply when the Recipient has returned all tangible embodiments of Licensed Technology in its possession to the Discloser.

  • Audits No more than once a year, or following unauthorized access, upon receipt of a written request from the LEA with at least ten (10) business days’ notice and upon the execution of an appropriate confidentiality agreement, the Provider will allow the LEA to audit the security and privacy measures that are in place to ensure protection of Student Data or any portion thereof as it pertains to the delivery of services to the LEA . The Provider will cooperate reasonably with the LEA and any local, state, or federal agency with oversight authority or jurisdiction in connection with any audit or investigation of the Provider and/or delivery of Services to students and/or LEA, and shall provide reasonable access to the Provider’s facilities, staff, agents and XXX’s Student Data and all records pertaining to the Provider, LEA and delivery of Services to the LEA. Failure to reasonably cooperate shall be deemed a material breach of the DPA.

  • Intellectual Property The Company and the Subsidiaries have, or have rights to use, all patents, patent applications, trademarks, trademark applications, service marks, trade names, trade secrets, inventions, copyrights, licenses and other intellectual property rights and similar rights necessary or required for use in connection with their respective businesses as described in the SEC Reports and which the failure to so have could have a Material Adverse Effect (collectively, the “Intellectual Property Rights”). None of, and neither the Company nor any Subsidiary has received a notice (written or otherwise) that any of, the Intellectual Property Rights has expired, terminated or been abandoned, or is expected to expire or terminate or be abandoned, within two (2) years from the date of this Agreement. Neither the Company nor any Subsidiary has received, since the date of the latest audited financial statements included within the SEC Reports, a written notice of a claim or otherwise has any knowledge that the Intellectual Property Rights violate or infringe upon the rights of any Person, except as could not have or reasonably be expected to not have a Material Adverse Effect. To the knowledge of the Company, all such Intellectual Property Rights are enforceable and there is no existing infringement by another Person of any of the Intellectual Property Rights. The Company and its Subsidiaries have taken reasonable security measures to protect the secrecy, confidentiality and value of all of their intellectual properties, except where failure to do so could not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect.

  • Representations and Warranties Borrower represents and warrants as follows:

  • Definitions As used in this Agreement, the following terms shall have the following meanings:

  • Confidentiality (a) Subject to Section 7.15(c), during the Term and for a period of three

  • Amendments This Agreement may not be amended, modified or waived as to any particular provision, except by a written instrument executed by all parties hereto.

  • Force Majeure If by reason of Force Majeure, either party hereto shall be rendered unable wholly or in part to carry out its obligations under this Agreement then such party shall give notice and full particulars of Force Majeure in writing to the other party within a reasonable time after occurrence of the event or cause relied upon, and the obligation of the party giving such notice, so far as it is affected by such Force Majeure, shall be suspended during the continuance of the inability then claimed, except as hereinafter provided, but for no longer period, and such party shall endeavor to remove or overcome such inability with all reasonable dispatch. Choice of Law The Agreement between the Vendor and TIPS/ESC Region 8 and any addenda or other additions resulting from this procurement process, however described, shall be governed by, construed and enforced in accordance with the laws of the State of Texas, regardless of any conflict of laws principles. Venue, Jurisdiction and Service of Process Any Proceeding arising out of or relating to this procurement process or any contract issued by TIPS resulting from or any contemplated transaction shall be brought in a court of competent jurisdiction in Camp County, Texas and each of the parties irrevocably submits to the exclusive jurisdiction of said court in any such proceeding, waives any objection it may now or hereafter have to venue or to convenience of forum, agrees that all claims in respect of the Proceeding shall be heard and determined only in any such court, and agrees not to bring any proceeding arising out of or relating to this procurement process or any contract resulting from or any contemplated transaction in any other court. The parties agree that either or both of them may file a copy of this paragraph with any court as written evidence of the knowing, voluntary and freely bargained for agreement between the parties irrevocably to waive any objections to venue or to convenience of forum. Process in any Proceeding referred to in the first sentence of this Section may be served on any party anywhere in the world. Venue for any dispute resolution process, other than litigation, between TIPS and the Vendor shall be located in Camp or Xxxxx County, Texas.

  • Background Purchaser wishes to purchase a Revenue Sharing Note issued by the Company through xxx.Xxxxxxxx.xxx (the “Site”).

  • Introduction The Texas Health and Human Services Commission ("HHSC") and the Contractor named in Section I (HHSC and Contractor may be referenced in this document collectively as the “Parties” and individually as the “Party") hereby enter into this Community Services Contract - Provider Agreement (the “Contract”) for the provision of services under the Contract type specified in Section I for the considerations set forth herein. The Contract Begin Date specified in Section I is not valid until this Contract is signed by both parties.

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