Adverse Reactions. Nmap Technology is not designed to crash systems and should not pose any problems for standards-conformant network equipment. However, some systems, devices, and applications have occasionally been reported to react adversely to port scans, OS detection, service detection probes, and NSE scripts. This is an error in the network device in question, and not in Nmap Technology. Nmap Technology should not be used against mission-critical systems without careful monitoring.
Adverse Reactions. The Company and the Manufacturer shall observe the procedures and notification requirements with respect to Adverse Reactions described in Schedule 7.5 attached hereto.
Adverse Reactions. Roche shall be responsible for reporting to the appropriate regulatory authorities all adverse events related to the use of Product worldwide, except that prior to the time Gilead transfers ownership of the IND to Roche as provided in Section 3.2(b), Gilead shall be responsible for the reporting of such adverse events in the U.S. Adverse events related to the use of Product worldwide shall be recorded in a single database, and the parties will coordinate their efforts to assure that all adverse events are reported properly.
Adverse Reactions. Each party shall be responsible for maintaining such records and making such reports as may be required in connection with any regulatory approval held by the party. Each party shall immediately inform the other of all adverse drug experience reports and other information relating to the safety or effectiveness of Product which come to its attention.
Adverse Reactions. Abrupt reversal of opioid effects in persons who are physically dependent on opioids may precipitate an acute opioid withdrawal syndrome. The acute opioid withdrawal syndrome may include: body aches, fever, sweating, runny nose, sneezing, piloerection, yawning, weakness, shivering or trembling, nervousness, restlessness or irritability, diarrhea, nausea or vomiting, abdominal cramps, increased blood pressure, tachycardia. A patient who develops a suspected adverse reaction to naloxone should call the pharmacy to report it. Pharmacists can recommend symptom management of the reaction, and/or patient referral. Development of life‐threatening symptoms should be immediately referred to the closest emergency room or urgent care clinic. Pharmacists should then report the adverse reaction to the FDA at MedWatch, found online at xxxxx://xxx.xxxxxxxxxx.xxx.xxx/scripts/medwatch/medwatch‐online.htm or 1‐800‐FDA‐1088. Patients can also report suspected adverse drug reactions directly to the FDA at MedWatch.
Adverse Reactions. Sponsor agrees that HCRI is not responsible for the costs of diagnosis, care and treatment of any undesirable side effects, adverse reactions, illness or injury to a participant in the Trial which result from participation in the Trial, except to the extent such costs arise directly from HCRI’s gross negligence or reckless or intentional misconduct. This section is not intended to create any third-party contractual benefit for any participants or Clinical Sites in the Trial.
Adverse Reactions. 6.1 Both Parties shall co-operate with one another and share information concerning the safety and efficacy of the Products and other information that may affect the use, sale and marketing of the Products.
6.2 Both Parties shall promptly notify each other in writing of any information concerning any serious or unexpected side-effect, injury, toxicity, or sensitivity reaction, any unexpected incidents or any adverse drug experience reports and the severity thereof associated with the Products, the use, sale and marketing thereof. Both Parties shall notify each other upon request by the other of other information concerning not serious adverse reactions attributable to the use of the Products.
6.3 Nothing in this Article shall be construed as overriding the duty and responsibilities of both Parties to report adverse reactions concerning the Product to any Regulatory Authorities in the Territory.
6.4 Both Parties shall advise each other of the names and contact details of persons responsible for pharmacovigilance / reporting of adverse reactions / medical information matters in its organisation and shall keep these details up to date.
Adverse Reactions. 43 SECTION 11.3
Adverse Reactions. The Development Committee shall establish procedures by which each Collaborator will receive notice from the other Collaborator and the JV, and will report to the JV and the other Collaborator, any adverse drug reactions related to a Product (including events related to products containing the same active ingredient as Products outside the Field and/or outside the Territory). The procedures shall be established by the Development Committee promptly after the Effective Date. Until such procedures ard approved, each Collaborator shall use its customary procedures in complying with the reporting requirements of applicable law and shall promptly furnish a written copy of any such report to the other Collaborator. Prior to the establishment of the JV, Cephalon shall serve as the reporting party for adverse events related to the Products.
Adverse Reactions. THERAPEUTICS shall be responsible for reporting to the appropriate regulatory authorities any and all adverse events related to the use of any Category I and Category II SDC Product(s), while INNOVATIVE shall bear said responsibility for all Category III SDC Product(s). Adverse events related to the use of any SDC Product(s) shall be recorded in a single database, maintained by THERAPEUTICS and the Parties will coordinate their efforts to assure that all adverse events are properly reported INNOVATIVE will report all adverse events to THERAPEUTICS within 5 days of notification regardless of the Category of the Product. In the event of termination or breach, or for any other reason THERAPEUTICS transfers its ownership of any Regulatory Filings for any SDC Product(s) to INNOVATIVE, INNOVATIVE shall assume and become responsible for the reporting of adverse events for any Category I and Category II SDC Product(s).
