SB-525 definition

SB-525 means Sangamo’s proprietary gene therapy product for Hemophilia A known as SB-525, as described in U.S. IND # 17250.
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SB-525 means Sangamo’s proprietary gene therapy product for Hemophilia A known as SB-525, as described in U.S. IND # 17250. 1.84 “SB-525 Phase I/II Long-Term Follow-Up Study” means the follow-on clinical study to the SB-525 Phase I/II Trial, which study’s purpose will be to further assess the safety of 15 [*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. patients from the SB-525 Phase I/II Trial, the protocol of which is set forth in the initial Development Plan, as may be amended from time to time. 1.85 “SB-525 Phase I/II Trial” means ▇▇▇▇▇▇▇’s first-in-human clinical trial of SB- 525, the protocol of which is set forth in the initial Development Plan, as may be amended from time to time, for example to address the need for clinical data on a manufacturing change. SB-525 Phase I/II Trial does not include the SB-525 Phase I/II Long-Term Follow-Up Study. 1.86 “Specified Patents” means those Patent Rights identified as the Specified Patents in that certain letter [*]. 1.87 “Sublicensee” means (a) with respect to Pfizer, any Person to whom Pfizer grants or has granted, directly or indirectly, a sublicense of rights licensed by Sangamo to Pfizer under this Agreement or (b) with respect to Sangamo, any Person to whom Sangamo grants or has granted, directly or indirectly, a sublicense of rights licensed by Pfizer to Sangamo under the Agreement. 1.88 “Target” means the Factor VIII gene (including partial versions of such gene), which, when defective, contributes to the human disease of Hemophilia A that can be treated by factor replacement. 1.89 “Territory” means worldwide. 1.90 “Third Party” means any Person other than a Party or an Affiliate of a Party. 1.91 “Trademarks” means all trademarks, service marks, trade names, service names, internet domain names, brand names, logos, protectable slogans, and trade dress rights, whether registered or unregistered, and all applications, registrations, and renewals thereof. 1.92 “United States” or “U.S.” means the United States of America, including its territories and possessions. 1.93 “Upstream Licensor” means any licensor of an Upstream License. 1.94 “[*]” means that certain [*]. 1.95 “Valid Claim” means, with respect to a particular country and Product (a) a claim of an issued and unexpired Patent Right in the Licensed Technology that (i) has not been revoked or held unenfo...
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Examples of SB-525 in a sentence

  • Each Committee (other than the JIPC, which shall meet only as directed to by the JSC) shall hold meetings at such times as it elects to do so, but in no event shall such meetings be held less frequently than (i) once every [*] months during the SB-525 Phase I/II Trial and (ii) once every [*] months thereafter.

  • Sangamo is the regulatory sponsor of each of the SB-525 Phase I/II Trial and the SB-525 Phase I/II Long-Term Follow-Up Study prior to the IND Transition Date, and, subject to Section 5.2, will hold the IND therefor.

  • From time to time during the Term (but no less than [*] during the SB-525 Phase I/II Trial and no less than [*] thereafter), the JCRC shall prepare updates and amendments to the then-current Development Plan(s) and submit such updates and amendment to the JSC for review and approval.

  • The Parties shall jointly prepare for each EOP2 Meeting relating to SB-525, including (a) formulating the plan for the further Development of SB-525 and the regulatory strategy and pathway to obtain Marketing Approval for SB-525; and (b) the review of any jointly-prepared correspondences and filings with the Regulatory Authorities in connection with such EOP2 Meeting.

  • In May 2017, Sangamo and Pfizer entered into an exclusive, global collaboration and license agreement for the development and commercialization of potential gene therapy products for Hemophilia A, including SB-525, which entered the clinic in August 2017.

  • As of the Effective Date, the Parties have agreed on the initial Development Plan for SB-525, which is attached hereto as Exhibit C (“SB-525 Development Plan”).

  • Upon Pfizer’s reasonable request, Sangamo shall provide Pfizer (or at additional cost, its CMO, if not Sangamo’s CMO for SB-525) with reasonable technical assistance and information, which shall include the provision of technical assistance and information identified in Exhibit F (Manufacturing Tech Transfer Plan), to enable Pfizer (or its CMO) to understand and utilize such Licensed Know-How in the Manufacture of SB-525.

  • Sangamo shall use reasonable efforts to amend the informed consent documents for the SB-525 Phase I/II Trial and the SB-525 Phase I/II Long-Term Follow-Up Study within three (3) months after the Effective Date to allow for Pfizer’s access to data and information as required under this Agreement, to the extent not already provided for therein.

  • Additionally, Sangamo shall be responsible for contracting with and overseeing a CMO to conduct manufacturing process development activities in preparation for the manufacture of SB-525 for use in the Pivotal Trial to be conducted in accordance with the form of statement of work attached hereto as Exhibit H.

  • Meetings of any Committee may be held in person, by audio or video teleconference; provided that unless otherwise agreed by both Parties, at least (i) [*] meetings per year for each Committee (other than JIPC) shall be held in person during the SB-525 Phase I/II Trial and (ii) [*] meeting per year for each Committee (other than JIPC) shall be held in person thereafter.