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 milestone payments of up to $764 million across a range of indications, potential sales-based milestones which under certain circumstances may exceed $200 million, and royalties on net sales are payable to Alder by ▇▇▇▇▇▇▇-▇▇▇▇▇ Squibb. Alder has an option to require ▇▇▇▇▇▇▇-▇▇▇▇▇ Squibb to make an equity investment of up to $20 million in Alder during an initial public offering. “With its novel mechanism of action, ALD518 has the potential to offer an exciting new option for patients with rheumatoid arthritis,” said ▇▇▇▇▇ ▇▇▇▇▇▇▇, M.D., Senior Vice President, Global Development & Medical Affairs, ▇▇▇▇▇▇▇-▇▇▇▇▇ Squibb. “We are pleased to have the opportunity to develop this novel monoclonal antibody. As part of our String of Pearls strategy, this transaction provides ▇▇▇▇▇▇▇-▇▇▇▇▇ Squibb with the opportunity to strengthen our immunoscience pipeline, and leverage our company’s experience in developing and delivering novel biologics to help patients prevail over rheumatoid arthritis and, potentially, other autoimmune diseases.” [***] = 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. “▇▇▇▇▇▇▇-▇▇▇▇▇ Squibb and Alder share the vision that ALD518 could become an important part of treating patients with rheumatoid arthritis,” said ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇▇, Ph.D., President and Chief Executive Officer of Alder Biopharmaceuticals. “▇▇▇▇▇▇▇-▇▇▇▇▇ Squibb’s extensive development and commercial experience in immunology translate into an exceptionally good fit for Alder, especially at this stage of our corporate development.” The effectiveness of the collaboration agreement is subject to antitrust clearance by the United States Federal Trade Commission and Department of Justice, under the provisions of the ▇▇▇▇-▇▇▇▇▇-▇▇▇▇▇▇ Antitrust Improvements Act of 1976 and other customary regulatory approvals. ALD518 is a humanized, monoclonal antibody, designed to block a pro-inflammatory molecule called interleukin-6 (IL-6), which plays a key role in the inflammatory cascade leading to the inflammation, swelling, pain, and destruction of large and small joints associated with rheumatoid arthritis. Based on the strong association of IL-6 with inflammatory disease, inhibition of IL-6 with ALD518 represents a promising new anti-inflammatory mechanism that could result in bone and joint preservation. ALD518 has completed Phase IIa development for rheumatoid arthritis. ALD518 is also being studied by Alder for the treatment of cancer and in cancer supportive care. Rheumatoid arthritis (RA) is a systemic,1 chronic, autoimmune disease characterized by inflammation in the lining of joints (or synovium), causing joint damage with chronic pain, stiffness, swelling and fatigue.2 RA causes limited range of motion and decreased function as a result of affected joints losing their shape and alignment.3 [***] = 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. RA affects about one percent of the world’s population,4 including more than one million people in the United States.1 The condition is more common in women than in men, who account for 75 percent of patients diagnosed with RA.2
Appears in 1 contract
Sources: Collaboration and License Agreement (Alder Biopharmaceuticals Inc)
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)—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 milestone payments of up to $764 million across a range of indications, potential sales-based milestones which under certain circumstances may exceed $200 million, and royalties on net sales are payable to Alder by ▇▇▇▇▇▇▇-▇▇▇▇▇ Squibb. Alder has an option to require ▇▇▇▇▇▇▇-▇▇▇▇▇ Squibb to make an equity investment of up to $20 million in Alder during an initial public offering. “With its novel mechanism of action, ALD518 has the potential to offer an exciting new option for patients with rheumatoid arthritis,” said ▇▇▇▇▇ ▇▇▇▇▇▇▇, M.D., Senior Vice President, Global Development & Medical Affairs, ▇▇▇▇▇▇▇-▇▇▇▇▇ Squibb. “We are pleased to have the opportunity to develop this novel monoclonal antibody. As part of our String of Pearls strategy, this transaction provides ▇▇▇▇▇▇▇-▇▇▇▇▇ Squibb with the opportunity to strengthen our immunoscience pipeline, and leverage our company’s experience in developing and delivering novel biologics to help patients prevail over rheumatoid arthritis and, potentially, other autoimmune diseases.” [***] = 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. “▇▇▇▇▇▇▇-▇▇▇▇▇ Squibb and Alder share the vision that ALD518 could become an important part of treating patients with rheumatoid arthritis,” said ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇▇, Ph.D., President and Chief Executive Officer of Alder Biopharmaceuticals. “▇▇▇▇▇▇▇-▇▇▇▇▇ Squibb’s extensive development and commercial experience in immunology translate into an exceptionally good fit for Alder, especially at this stage of our corporate development.” The effectiveness of the collaboration agreement is subject to antitrust clearance by the United States Federal Trade Commission and Department of Justice, under the provisions of the ▇▇▇▇-▇▇▇▇▇-▇▇▇▇▇▇ Antitrust Improvements Act of 1976 and other customary regulatory approvals. ALD518 is a humanized, monoclonal antibody, designed to block a pro-inflammatory molecule called interleukin-6 (IL-6), which plays a key role in the inflammatory cascade leading to the inflammation, swelling, pain, and destruction of large and small joints associated with rheumatoid arthritis. Based on the strong association of IL-6 with inflammatory disease, inhibition of IL-6 with ALD518 represents a promising new anti-inflammatory mechanism that could result in bone and joint preservation. ALD518 has completed Phase IIa development for rheumatoid arthritis. ALD518 is also being studied by Alder for the treatment of cancer and in cancer supportive care. Rheumatoid arthritis (RA) is a systemic,1 chronic, autoimmune disease characterized by inflammation in the lining of joints (or synovium), causing joint damage with chronic pain, stiffness, swelling and fatigue.2 RA causes limited range of motion and decreased function as a result of affected joints losing their shape and alignment.3 [***] = 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. RA affects about one percent of the world’s population,4 including more than one million people in the United States.1 The condition is more common in women than in men, who account for 75 percent of patients diagnosed with RA.2
Appears in 1 contract
Sources: Collaboration and License Agreement (Alder Biopharmaceuticals Inc)