Wow, PII trial agreement.. the P3 took 15-20 years, so, you have VERY OLD information.
Document says she is working on behalf of UCLA and that NWBO is to pay UCLA... mind-blowing info.
This exhibit defines the nature, scope and content of work to be performed under the direction of Dr. Linda Liau, M.D., Ph.D., as Principal Investigator, working on behalf of the UNIVERSITY (UCLA) and to be delivered to the SPONSOR (NORTHWEST BIOTHERAPEUTICS, INC.) in accordance with the terms of this contract.
1. NATURE OF WORK: The University and Sponsor will jointly develop a research program defined below and also an application for a Phase II Investigational New Drug (IND) application entitled, "AUTOLOGOUS DENDRITIC CELLS PULSED WITH AUTOLOGOUS GLIOBLASTOMA TUMOR PEPTIDES," that will be submitted by the Sponsor to the Federal Drug Administration (FDA). This Phase II IND application is specifically intended to support a clinical trial performed by UCLA investigators in conjunction with the Sponsor and may not be used by the Sponsor for any other purpose unless specified and agreed to in writing by both parties.
2. SCOPE OF WORK: The work to be performed by the University falls into 3 categories:
A. Develop and validate a protocol for preparing GMP-quality suspensions of viable glioblastoma cancer cells from patients with glioblastoma, and develop protocol for preparing GMP quality peptides derived from tumor cells. Transfer the technology to Sponsor. B. Collaborate in the design and writing of sections for the IND application. C. Perform research relevant to program as defined by University and Sponsor.
3. CONTENT OF WORK:
A. Develop and validate a protocol for preparing GMP-quality suspensions of viable glioblastoma cancer cells from patients with glioblastoma multiforme and technology developed technology to Sponsor. University investigators will collect cancer specimens from the operating room and evaluate techniques for preparing purified tumor cell suspensions from these clinical samples. The goal will be to develop a GMP-quality process by which tumors recovered at the time of surgery can be placed into a transportation media and delivered to the Sponsor's cell processing facility in the form of a viable cell suspension. In addition, techniques for purifying, characterizing and culturing the tumor cell suspension after its arrival at the Sponsor's facility will be investigated. Techniques for "stripping" peptides from the surface of tumor cells and concentration of these peptides will also be developed. Results from these investigations will be formed into a detailed written protocol that will be delivered to the Sponsor. This protocol will employ GMP-quality reagents, as feasible given their current availability. The average viability, cell yield and purity of the cancer cell suspension as well as quantities of peptides "stripped" from the tumor cell surface will be reported to the Sponsor.
7 <PAGE> 8 B. Design and write sections of the IND protocol. University investigators will, in discussion and collaboration with the Sponsor, develop a Clinical Trial Protocol and sections of a corresponding IND application for a study entitled, "PHASE II TRIAL EVALUATING AUTOLOGOUS DENDRITIC CELLS PULSED WITH AUTOLOGOUS GLIOBLASTOMA PEPTIDES FOR THE ADJUVANT TREATMENT OF MALIGNANT GLIOMA." The following sections will be prepared:
i. General Investigational Plan
ii. Investigators Brochure
iii. Detailed Protocol to include an Introduction, Objectives, Study Hypothesis and Endpoints, Treatment Plan, Pretreatment Evaluation, On Study Evaluation, Concomitant Medications, Adverse Events, and Criteria for Disease Evaluation.
iv. UCLA IRB application conforming to study guidelines.
8 <PAGE> 9 UCLA / NORTHWEST BIOTHERAPEUTICS, INC. (AGREEMENT NO. 01082716) "DEVELOPMENT AND VALIDATION OF DENDRITIC CELLS PULSED WITH AUTOLOGOUS GLIOBLASTOMA TUMOR PEPTIDES"
EXHIBIT B - DELIVERABLES
This exhibit defines the deliverables to be provided by Linda Liau, M.D., Ph.D. as Principal Investigator, working on behalf of the UNIVERSITY, to the SPONSOR in accordance with the terms of this contract.
A. Develop and validate a protocol for preparing GMP-quality suspensions of viable glioblastoma cancer cells from patients with glioblastoma multiforme. This deliverable includes identification of reagents and resources for the IND protocol. University investigators will identify and make known to the Sponsor a list of products and manufacturers conforming to FDA-approved good manufacturing practices (GMP) as required to carry out the protocol. University investigators will prepare a detailed written protocol that will be delivered to the Sponsor. This protocol will employ GMP-quality reagents, as feasible given their current availability. The average viability, cell yield and purity of the cancer cell suspension will be reported to the Sponsor. These protocols for pre]2aring materials for clinical trial will be transferred to Sponsor.
B. Design and write sections of the IND protocol. University investigators will, in discussion and collaboration with the Sponsor, deliver the following written sections of a Clinical Trial Protocol and corresponding IND application for a study entitled, "PHASE II TRIAL EVALUATING AUTOLOGOUS DENDRITIC CELLS PULSED WITH AUTOLOGOUS GLIOBLASTOMA PEPTIDES FOR THE ADJUVANT TREATMENT OF MALIGNANT GLIOMA."
i. General Investigational Plan
ii. Investigators Brochure
iii. Detailed Protocol to include an Introduction, Objectives, Study Hypothesis and Endpoints, Treatment Plan, Pretreatment Evaluation, On Study Evaluation, Concomitant Medications, Adverse Events, and Criteria for Disease Evaluation.
iv. UCLA IRB application conforming to study guidelines
C. Research results from sponsored research agreement. Quarterly reports will be delivered to Sponsor covering activities for the previous three months.
9 <PAGE> 10 EXHIBIT C - PAYMENT SCHEDULE
One fourth (25% or $19,125) of total direct and indirect costs ($76,500) will be paid to the University within ten (10) days of the signing date of this agreement. One-third of the remaining balance ($19,125) will be paid to the University at quarterly intervals thereafter.
