Adverse Reaction Reporting. EAGLE shall be responsible for handling all adverse event reporting (including with regulatory authorities) relating to the PRODUCTS in the TERRITORY.
Adverse Reaction Reporting. Each Party shall keep the other Party informed of information in or coming into its possession or control concerning side effects, injury, toxicity or sensitivity reaction and incidents of severity thereof associated with commercial and clinical uses, studies, investigations or tests of each Product in the Territories, whether or not determined to be attributable to the Product. SuperGen shall be responsible for filing with the FDA, as required pursuant to 21 C.F.R. Sec. 314.80, any adverse reaction reports that it receives. Xxxxxx shall be responsible for filing with the appropriate regulatory authorities in the International Territory, as required, adverse reaction reports that it receives. Within four (4) months of the Effective Date, the respective pharmacovigilance groups of SuperGen and Xxxxxx shall enter into a separate agreement covering adverse event information exchange relating to the Product.
Adverse Reaction Reporting. Each party shall advise the other party, by telephone or facsimile, within such time as is required to comply with Applicable Laws after it becomes aware of any adverse reaction involving the Licensed Product. Such advising party shall provide the other party with a written report delivered by confirmed facsimile of any adverse reaction, stating the full facts known to it, including but not limited to customer name, address, telephone number, batch, lot and serial numbers, as required by Applicable Laws. To the extent permitted by Applicable Laws, E-Z-EM shall have full responsibility for monitoring such adverse reactions and making any reports to the Competent Authorities, with a complete copy provided to Pharmacyclics at the same time the report is made to the Competent Authorities. Within thirty (30) days before the First Commercial Sale or any test or trial conducted on GADOLITE(R) by E-Z-EM or its designee, the parties agree to agree upon and finalize the SOP, provided that such SOP shall be E-Z-EM's current SOP, modified only to the extent necessary to provide a mechanism for E-Z-EM to provide information to Pharmacyclics that is necessary under Applicable Laws for Pharmacyclics to provide to the FDA. The parties agree to follow the SOP. In the event responsibilities exist with respect to compliance with Applicable Laws pursuant to this section which cannot be delegated to E-Z-EM by * INDICATES THAT MATERIAL HAS BEEN OMITTED AND CONFIDENTIAL TREATMENT HAS BEEN REQUESTED THEREFOR. ALL SUCH OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE COMMISSION PURSUANT TO RULE 24b-2.
Adverse Reaction Reporting. (a) Each Party shall record, evaluate, summarize and review all adverse drug experiences associated with the Compound and the Product. In order that each Party may be fully informed of the adverse drug experiences associated therewith that are known to the other Party, each Party shall report:
(i) In the case of Inspire, to: Inspire Pharmaceuticals, Inc. 0000 Xxxxxxx Xxxxxxxxx, Xxxxx 000 Xxxxxx, Xxxxx Xxxxxxxx 00000 XXX Attention: XxXxx Xxxxxx, Manager, Regulatory Affairs & Project Management Facsimile No.: (000) 000-0000 Telephone No.: (919) 941-9777 ext. 288
(ii) In the case of Santen, to: Santen Pharmaceutical Co., Ltd. 0-0-00 Xxxxxxxxxxx Xxxxxxxxxxxxxxx-xx Xxxxx 000-0000 XXXXX Attention: Xxxx Xxxxxxxx, Ph.D., Deputy General Manager Facsimile No.: (00) 0000-0000 Telephone No.: (00) 0000-0000
Adverse Reaction Reporting. During the term of this Agreement, MOVA shall immediately but in any case within twenty-four (24) hours notify DEPOMED, by facsimile or telephone, of any adverse drug experience involving the Product that a responsible employee of MOVA becomes aware of.
Adverse Reaction Reporting. (a) Alcon shall advise Pharmacyclics, by telephone or facsimile, within such time as is required by the FDA or foreign equivalent (with respect to the severity and/or increased frequency of such adverse reaction) after it becomes aware of any adverse reaction to the use of the Licensed Product developed, marketed or sold by Alcon. Alcon shall provide Pharmacyclics with a written report delivered by confirmed facsimile of any reported adverse reaction, stating
Adverse Reaction Reporting. Each of Dyax and Genzyme shall notify the other Parties of any adverse reaction information relating to any Collaboration Product within twenty-four (24) hours of the receipt of such information and as necessary for compliance with regulatory requirements. "ADVERSE REACTION INFORMATION" includes without limitation information relating to any experience that (a) suggests a significant hazard, contraindication, side effect or precaution, (b) is fatal or life threatening, (c) is permanently disabling, (d) requires or prolongs inpatient hospitalization, (e) involves a congenital anomaly, cancer or overdose or (f) is one not identified in nature, specificity, severity or frequency in the current investigator brochure or the United States labeling for the Collaboration Product.
Adverse Reaction Reporting. Each of Dyax and Genzyme shall notify the other Parties of any adverse reaction information relating to any Collaboration Product within twenty-four (24) hours of the receipt of such information and as necessary for compliance with regulatory requirements. "Adverse reaction information" includes without limitation information relating to any experience that (a) suggests a significant hazard, contraindication, side effect or precaution, (b) is fatal or life threatening, (c) is permanently disabling, (d) requires or prolongs inpatient hospitalization, (e) involves a congenital anomaly, cancer or overdose or (f) is one not identified in nature, specificity, severity or frequency in the current investigator brochure or the United States labeling for the Collaboration Product.
Adverse Reaction Reporting. Each Party shall record, evaluate, summarize and review all adverse drug experiences associated with the Compound and the Product. In order that each Party may be fully informed of the adverse drug experiences associated therewith that are known to the other Party, each Party shall report: In the case of Scynexis, to: SCYNEXIS, Inc. 3000X Xxxxxxxxx Xxxx. Xxxxxx, XX 00000 XXX Attention: E-mail:kxxxxx.xxxxxxx-xxxxx@xxxxxxxx.xxx Facsimile No.: Telephone No.:+1 919. 237.4431 In the case of R-Pharm, to: Attention: Sxxxxx Xxxxxxx, MD, PhD Head of Drug Safety and Pharmacovigilance E-mail: sxxxxx@xxxxxx.xx sx.xxxxxxx@xxxxxx.xx Facsimile No.: +0-000-000-00-00 Telephone No.: +0-000-000-00-00 [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
Adverse Reaction Reporting. Each of Diacrin and Genzyme shall notify Diacrin/Genzyme LLC and the other Party of any adverse reaction information relating to any Collaboration Product within twenty-four (24) hours of the receipt of such information and as necessary for compliance with regulatory requirements. Adverse reaction information includes without limitation information relating to any experience that suggests a significant hazard, contraindication, side effect or precaution, any experience that is fatal or life threatening, is permanently disabling, requires or prolongs inpatient hospitalization, or is a congenital anomaly, cancer, or overdose or any experience that is one not identified in nature, specificity, severity or frequency in the current investigator brochure or the United States labeling for the Collaboration Product.
