Report Type   Timeframe   Format   Method Clause Samples

Report Type   Timeframe   Format   Method. Unexplained and fatal or life-threatening adverse event associated with use of Product as set forth in ICH guidelines [***] [***] FAX and e-mail All other serious attributable* (related) ICSRs and pregnancies [***] [***] FAX and e-mail Serious non-attributable (not related) ICSRs [***] [***] FAX and e-mail Non-serious attributable* (related) and non-attributable (not related) ICSRs [***] Attributable (i.e., [***]) by either the investigator or a Party. Each Party is responsible for complying with all applicable investigational and post-marketing safety reporting regulations with respect to the use of the Product as subject to the terms of this Agreement. This includes submission of expedited and periodic reports to the appropriate Regulatory Authority(s). [***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED. All information to be reported to a Party under this Exhibit shall be sent as follows (or to such other address, contact person, telephone number, facsimile number or e-mail address as may be specified in writing to the other Party): To BMS, at: ▇▇▇▇▇▇▇-▇▇▇▇▇ Squibb Company Adverse Event Processing ▇▇▇ ▇▇▇▇▇▇▇▇▇▇-Rocky Hill Road HW 19 1.01 ▇▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇ ▇▇▇ Fax: ▇▇▇-▇▇▇-▇▇▇▇ Email: ▇▇▇▇▇▇▇▇▇.▇▇▇▇▇▇@▇▇▇.▇▇▇ To Alder, at: Alder Biopharmaceuticals Inc. ▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇ Attention: Chief Medical Officer Fax: ▇▇▇-▇▇▇-▇▇▇▇ [***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED. (PRINCETON, New Jersey, and BOTHELL, Washington, October XX, 2009)—▇▇▇▇▇▇▇-▇▇▇▇▇ Squibb Company (NYSE:BMY) and Alder Biopharmaceuticals, Inc., today announced a global agreement for the development and commercialization of ALD518, a novel biologic that has completed Phase IIa development for the treatment of rheumatoid arthritis. Under the terms of the collaboration agreement, Alder will grant to ▇▇▇▇▇▇▇-▇▇▇▇▇ Squibb worldwide exclusive rights to develop and commercialize ALD518 for all potential indications except cancer, for which Alder will retain rights and ▇▇▇▇▇ ▇▇▇▇▇▇▇-▇▇▇▇▇ Squibb an option to co-develop and commercialize outside the United States. An upfront cash payment of $85 million, potential development-based and regulatory-based m...