TECHNOLOGY AND KNOW-HOW TRANSFER. Transfer activity Success Criteria Target Date Provision of documentation relevant to [***] as set out further in Exhibit A1 [***] [***] [***] [***] [***] Adaptimmune to provide knowledge transfer of [***] process to GSK [***] [***] Adaptimmune to provide knowledge transfer of the following supporting [***] [***] Transfer activity Success Criteria Target Date analytics: [***] Adaptimmune to facilitate training on process from [***] for GSK [***] [***] [***]
TECHNOLOGY AND KNOW-HOW TRANSFER. (a) In the event Schering becomes a manufacturer of the Product pursuant to Section 6.03 or Section 6.08, Alliance will transfer to Schering all relevant and necessary technology and know-how related to the manufacturing process, including but not limited to manufacturing descriptions, master batch records, executed batch records, release specifications and release testing methods (for active pharmaceutical ingredients, other raw materials, packaging material and finished products), in process testing methods, in process specifications, annual product reviews, validation reports, techniques and formulae, equipment descriptions in order to enable Schering to manufacture the Product for its, or its Affiliates' requirements of Product.
TECHNOLOGY AND KNOW-HOW TRANSFER. Transfer activity Success Criteria Target Dates [***] [***] [***] Delivery of complete data packages [***] [***] [***] [***] [***]
TECHNOLOGY AND KNOW-HOW TRANSFER. Transfer activity Success Criteria Target Date Provision of documentation relating to [***] as set out further in Exhibit A1 - Delivery of documentation As set out in documentation list [***] [***] [***] Knowledge transfer for [***] - Covered under Section 11.3 above See Section 11.3 above
TECHNOLOGY AND KNOW-HOW TRANSFER. Transfer activity Success Criteria Target Date Transfer of all clinical study documentation listed in Documentation List in Exhibit A1 [***] [***] Transfer of clinical trial knowledge to GSK [***] [***] Transfer of Clinical Safety and Pharmacovigilance knowledge to GSK [***] [***] Transfer of site communications. [***] [***] [***] Transfer of Sponsor responsibility - See regulatory section below See regulatory section below Transfer of all clinical databases to GSK - See biometrics, pharmacovigilance and CDx sections below See biometrics, pharmacovigilance and CDx sections below Transfer of Study conduct for each site that participates in an ongoing NYESO study [***] [***] Transfer of ability to manufacture product for patients and to fully support all studies - See CMC below See CMC below CSR, DSUR and IB completion and transfer See relevant sections below See relevant sections below Transfer of clinical samples See relevant sections below See relevant sections below Transfer of relevant vendors’ activities [***] See relevant sections below
TECHNOLOGY AND KNOW-HOW TRANSFER. Transfer activity Success Criteria Target Date Transfer of all regulatory documentation listed in Documentation List in Exhibit A1 [***] [***] Knowledge transfer [***] [***] Transfer of sponsorship for clinical trials to GSK [***] [***]
TECHNOLOGY AND KNOW-HOW TRANSFER. Transfer activity Success Criteria Target Dates Writing and filing of DSUR [***] [***]
TECHNOLOGY AND KNOW-HOW TRANSFER. Transfer activity Success Criteria Target Dates [***] [***] [***] Provision of knowledge transfer to GSK [***] [***]
TECHNOLOGY AND KNOW-HOW TRANSFER. Transfer activity Success Criteria Target Dates Provision of list of patient samples capable of transfer to GSK in excel format, together with confirmation of appropriate consents for each sample (to the extent available from site) [***] [***] Provision of samples on above list to GSK’s approved third party vendor [***] [***]
TECHNOLOGY AND KNOW-HOW TRANSFER. Transfer activity Success Criteria Target Date Provision of list and contacts for third party suppliers of quality agreements and audit reports for third party suppliers [***] [***] Provision of documentation relevant to such third party suppliers as set out further in Exhibit A1 - Delivery of documentation As set out in documentation list [***] [***] [***]
