SERVICES AGREEMENT TO PROVIDE CANCER SAMPLES AND RELATED BIOLOGICAL FLUID SAMPLES

1.1

“ Affiliate ” of a specified entity shall mean an entity that directly or indirectly controls, is controlled by, or is under common control with, the entity specified. For this purpose, “control” shall mean the possession, directly or indirectly, of the power to direct or cause the direction of the management and policies of the entity whether through voting shares, securities or otherwise.

1.2

“ Cancer Sample ” shall mean a sample of a human cancer prepared according to the procedures set forth in Appendix A. The term Cancer Sample preceded by a cancer type, e.g., renal Cancer Sample, shall mean that the Cancer Sample is derived from a cancer of that type. The human cancer which constitutes a Cancer Sample can include, without limitation, a tumor and a carcinoma.

1.3

“ Corresponding Cancer Sample ”, with respect to a Section, shall mean the Cancer Sample from which the Section is obtained.

1.4

“ Material ” shall mean Cancer Sample, Section, Serum Sample and/or Urine Sample.

1.5

“ Section ”, with respect to a Cancer Sample, shall mean (i) a slice of the Cancer Sample prepared according to the procedures set forth in Appendix A, or (ii) a photomicrograph of such slice.

1.6

“ Serum Sample ” shall mean a sample of human serum prepared according to the procedures set forth in Appendix A.

1.7

“ Supervisor ” shall mean the individual specified in Paragraph 2.9 having primary responsibility for directing the services provided by the University under this Agreement. Supervisor shall have primary responsibility for directing, without limitation, the following:

1.7.1

Providing Materials to Lixte;

1.7.2

Ensuring University’s adherence to the time limitations set forth in Paragraphs 2.2 and 2.4 of this Agreement;

1.7.3

Obtaining all necessary authorizations, licenses, consents and approvals from University’s ethics board (or equivalent);

1.7.4

Ensuring that all Materials sent to Lixte are anonymous, i.e. that all patient identifiers are removed therefrom;

1.7.5

Maintaining a patient key to permit University to provide certain additional information to Lixte with respect to each patient from whom Material is obtained;

1.7.6

Ensuring that University’s performance of its obligations under this Agreement are performed in accordance with good clinical practice; and

1.7.7

Supervising and documenting all individuals performing tasks in connection with University’s obligations under this Agreement.

1.8

“ Surgery ”, with respect to a Cancer Sample, shall mean the attempted curative surgery during which the solid tissue for the Cancer Sample is obtained.

1.9

“ Urine Sample ” shall mean a sample of human first morning urine prepared according to the procedures set forth in Appendix A.

2.1

For each of the cancer-afflicted patients identified in Subparagraphs 2.1.1-2.1.8 below, University shall provide to Lixte for its inspection one Section of a Cancer Sample obtained from such patient:

2.1.1

at least 10 patients afflicted with pancreatic cancer;

2.1.2

at least 20 patients afflicted with stomach carcinomas, including at least 10 patients afflicted with diffuse-type stomach tumors and at least 10 patients afflicted with intestinal-type stomach tumors;

2.1.3

at least 10 patients afflicted with breast adenocarcinomas;

2.1.4

at least 10 patients afflicted with bladder carcinomas;

2.1.5

at least 10 patients afflicted with renal cell cancers;

2.1.6

at least 10 patients afflicted with prostate adenocarcinomas;

2.1.7

at least 10 patients afflicted with colon adenocarcinomas; and

2.1.8

at least 30 patients afflicted with ovarian carcinomas, including at least 10 patients afflicted with serous carcinomas, and including, if the numbers of patients permit, (i) at least 10 patients afflicted with mucinous carcinomas, and (ii) at least 10 patients afflicted with endometroid carcinomas.

2.2

Within six (6) months of the Effective Date, University shall provide to Lixte at least one-half of the Sections it is obligated to provide pursuant to Paragraph 2.1, namely at least 55 Sections, with the proviso that these 55 Sections are comprised of 10 Sections from the 20-patient group of Subparagraph 2.1.2, 15 Sections from the 30-patient group of Subparagraph 2.1.8, and 5 Sections from each of the 10-patient groups of Subparagraphs 2.1.1 and 2.1.3-2.1.7.

2.3

After receiving each Section from University pursuant to Paragraph 2.1, Lixte may inspect the Section and (i) if based on that inspection the Corresponding Cancer Sample meets the specifications set forth in Appendix A, Lixte may request that University provide to it the Corresponding Cancer Sample, or (ii) if based on that inspection the Cancer Sample deviates from the specifications set forth in Appendix A, Lixte may request that University provide to it a Section of a Cancer Sample from the same patient or another patient with the same type of cancer. Lixte may repeat the request of part (ii) of this Paragraph until University is able to provide Lixte with a Cancer Sample which meets the specifications set forth in Appendix A, provided that Lixte may not repeat the request of part (ii) of this Paragraph more than two (2) times.

2.4

Within sixty (60) days after receiving Lixte’s request for a Cancer Sample pursuant to part (i) of Paragraph 2.3, University shall provide Lixte with that Cancer Sample.

2.5

Along with each Cancer Sample which University provides to Lixte pursuant to Paragraph 2.4, University shall also provide to Lixte two (2) Serum Samples taken from the same patient from whom the Cancer Sample was obtained, wherein the first Serum Sample is obtained within four weeks before Surgery, and the second Serum Sample is obtained one to six weeks after Surgery.

2.6

Along with each renal and bladder Cancer Sample which University provides to Lixte pursuant to Paragraph 2.4, University shall also provide to Lixte (i) a first Urine Sample taken from the same patient from whom the Cancer Sample was obtained, wherein the first Urine Sample is obtained within four weeks before Surgery, and (ii) if feasible for the University, a second Urine Sample taken from the same patient from whom the Cancer Sample was obtained, wherein the second Urine Sample is obtained one to six weeks after Surgery.

2.7

University agrees that all Materials will be obtained under informed consent meeting all the regulations of University and those of all applicable jurisdictions in Germany. Lixte is aware of each patient’s right to withdraw informed consent. In each instance where a patient withdraws consent, University will inform Lixte of such withdrawal and Lixte, once so informed, will not thereafter use any Material obtained from the patient who withdrew consent. All Materials provided to Lixte must be obtained as part of a clinically indicated procedure and must not be needed for clinical management, that is, all Materials should be “waste” tissue released by the responsible pathologist after taking all material needed for diagnosis and management.

2.8

The parties agree that any Material provided to Lixte which is obtained from a given patient will be accompanied by information about that patient and the method by which the Material was obtained, according to the procedures set forth in Appendix A, with the proviso that no information will be provided to Lixte which would reveal the identity of any patient from whom Material has been obtained.

2.9

The parties agree that Dr. Arndt Hartmann, Institute of Pathology, University of Regensburg, will act as Supervisor. Should Dr. Hartmann become unable or unwilling to perform such role, University will promptly select another individual to act as Supervisor, subject to Lixte’s approval. If a suitable Supervisor is not identified by the University, the parties acknowledge that Lixte may terminate this Agreement pursuant to Paragraph 6.2.

2.10

At Lixte’s request and expense, University will continue to store all or portions of all Materials for up to two (2) years after termination or expiration of this Agreement.

2.11

Lixte has the right to review the quality of Material selection, characterization and storage at any time during the term of this Agreement. If the quality is less than that required for Lixte’s purposes, Lixte will notify Supervisor who will work with Lixte to achieve the desired level of quality.

2.12

Lixte reserves the right to request in writing one or more minor changes in the procedures set forth in Appendix A without incurring additional cost provided the changes are no more demanding with respect to University’s time and supplies than the requirements specified in Appendix A as of the Effective Date, and provided that the changes are in compliance with applicable German laws and regulations. In each instance where Lixte requests a change pursuant to this Paragraph, Lixte will inform University in writing of such request, specifying the change requested. University, once so informed, will thereafter implement the requested change. University’s obligation to implement changes requested under this Paragraph shall not apply retroactively to procedures followed prior to such request.

2.13

Lixte is free to use any Material provided under this Agreement for the purpose of analyzing markers (e.g., morphological, molecular and metabolic markers) in tumors, cancer cells, serum and urine which may have use in the development of methods for understanding carcinogenesis, for detecting and assessing cancer behavior, for assessing the efficacy of cancer treatments, and for developing improved cancer treatments.

2.14

Lixte has no obligation during or after the term of this Agreement to provide or otherwise disclose to University or any third party any material or information which Lixte or its Affiliates produce or derive using any Material or information provided by University under this Agreement.

2.15

Neither Lixte nor any of its Affiliates shall have any obligation during or after the term of this Agreement to contribute, directly or otherwise, to the treatment or care of any patient in the care of the University, particularly any