Adverse Reactions Clause Samples

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. ***** Confidential Treatment Requested

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 ▇▇▇▇▇://▇▇▇.▇▇▇▇▇▇▇▇▇▇.▇▇▇.▇▇▇/scripts/medwatch/medwatch‐online.htm or 1‐800‐FDA‐

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).

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. 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. In the event that either party receives any complaint regarding the Product, it shall notify the other party immediately after becoming aware of it. ▇▇▇▇▇▇▇ will make an assessment of each complaint it receives, provide BIOMATERIALI with these complaint assessments and will coordinate all follow-up and customer communication that it deems appropriate. ▇▇▇▇▇▇▇ will assist BIOMATERIALI in its decision process about whether a complaint shall have to be notified to a local competent authority and the Notified Body or not and for implementing of appropriate Field Corrective Actions. In the event that any customer of ▇▇▇▇▇▇▇ rejects or returns a Product to ▇▇▇▇▇▇▇ as a result of a Product performance problem, ▇▇▇▇▇▇▇ shall immediately so notify BIOMATERIALI and confirm in writing. If the reason for such performance problem is reasonably determined to be failure of the Product to meet its specifications, then BIOMATERIALI will replace, at its sole expense, the non-conforming Product which ▇▇▇▇▇▇▇ elects to so replace. In such case, BIOMATERIALI will pay all shipping and handling costs of ▇▇▇▇▇▇▇ relating to the handling, replacement and return of the rejected Product.

Adverse Reactions. Distributor shall advise Keystone within twenty-four (24) hours of any adverse reaction, injury or death resulting from any use of the Products (an “Adverse Reaction”) of which it becomes aware. Distributor shall also, within five (5) days thereafter, provide Keystone with a written report stating the full facts known to it concerning the Adverse Reaction, including, but not limited to, customer name, address, telephone number and Product lot or serial number. Keystone shall, from time to time, provide Distributor with written procedures regarding the information required by Keystone in the event of any Adverse Reaction. At all times during the term of this Agreement, Distributor shall have appropriate written procedures established for processing any Adverse Reaction, and shall provide the same to Keystone upon request. As part of such procedures, Distributor shall establish a means for properly (a) tracking delivery of Products to customers (including all customers who receive Products from subdistributors), including, without limitation, tracking which customers have received Products from particular lot numbers and/or bearing particular serial numbers, and (b) maintaining its distribution records for the Products for a reasonable time period. All information related to any Adverse Reaction shall be considered Confidential Information of Keystone, and shall therefore be subject to the provisions of Section 7 below.