AGREEMENT BETWEEN NATIONAL PHYSICIANS COOPERATIVE (NPC) OF THE ONCOFERTILITY CONSORTIUM®AT [ENTER CENTER NAME]
AND REPROTECH, LTD.
Be it resolved that the purpose of this agreement is to define the conditions under which ReproTech, Ltd.,33 Fifth Avenue NW, Suite 900,St Paul, MN 55112 is the exclusive provider of long term storage services for cryopreserved ovarian tissue processed as part of the following Center’s participation in the National Physicians Cooperative (NPC) [NIH Grant U54RR024347] of the Oncofertility Consortium®at [ENTER CENTER NAME], [ENTER CENTER ADDRESS].
I. General Terms and Conditions:
- It is understood that ReproTech (RTL) will list the National Physicians Cooperative (NPC) of the Oncofertility Consortium® at [ENTER CENTER NAME] [ASK FOR CENTER CODE]site(s) providing ovarian tissue cryopreservation services for cancer and other patients on its Freezing Center Network listing on its website ( and marketing brochures.
- It is understood that ReproTech’s staff will perform specimen transfers from [ASK FOR CENTER CODE]’ssite to RTL’s storage center for patients providing tissues to the National Physicians Cooperative.
- It is understood that [ASK FOR CENTER CODE] will transfer patient’s cryopreserved ovarian tissue specimens to RTL, after they have completedovarian tissue cryopreservation procedures. These specimens will include:patient samples of ovarian tissue, accompanying patient plasma samples and research samples.
II. ReproTech, Ltd. Responsibilities
1. Forms and literature
ReproTech will provide the necessary packets of forms (ovarian tissue) and support literature required to facilitate a smooth process for both the patients and [ASK FOR CENTER CODE]staff. These forms will include:
Registration
Transfer to ReproTech Authorization
Storage Agreement
Infectious disease addendum (if needed)
Specimen Transfer Data (not in packet, but provided to lab staff)
- Specimen Transfers
- ReproTech will provide specimen transfers on an as needed basis for [ASK FOR CENTER CODE]. Every attempt will be made to coordinate shipments toinclude as many patients as possible in order to keep the shipping feeseconomicalunless the specimen to be transferred is classified as “potentially infectious” and requires separate shipping.
- If [ASK FOR CENTER CODE] does not have short term storage capabilities, RTL will ship a dry shipper to [ASK FOR CENTER CODE] prior to the ovarian tissue retrieval to allow [ASK FOR CENTER CODE] to place the cryopreserved tissue directly into RTL’s shipper for immediate transport to RTL for storage.
- RTL will provide a dry shipper dedicated to the transport of either non-infectious or potentially infectious cryopreserved ovarian tissue.
3. Storage Parameters
- ReproTech will provide long-term storage of cryopreserved ovarian tissue including both the tissue owned by the patient (80%), accompanying plasma samples and that dedicated to research (20%) in accordance with Federal/State Regulations, ASRM Guidelines, and AATB Standards.
- At the direction of Mary Ellen Pavone,Director of the National Physicians Cooperative (in consultation with the Oncofertility Consortium® Steering Committee), RTL will transfer the ovarian tissue designated for research to the indicated research center.
- RTL will provide storage services for cryopreserved ovarian tissue identified as “potentially infectious” due to a reactive or positive patient infectious disease test result. The patient will be required to complete an additional form (addendum).
4. StorageConditions and Monitoring
- ReproTech will store cryopreserved ovarian tissue owned by patients and that dedicated for research in a dedicated storage tank(s).
- All tissue will be stored in the liquid phase of nitrogen. Each storage tank will be continuously monitored by a REES Monitoring system which monitors storage temperatures and alerts RTL staff if storage conditions are outside of acceptable parameters.
- Tissue identified as “potentially infectious” will be stored in the vapor phase of nitrogen with other such identified tissue but stored in separate canisters or tanks by disease type.
5. Fees
- Initial shipping of patient samples and the first year of storage of patient samples will be paid by the National Physicians Cooperative.
- ReproTech, will assess patients directly for all subsequent fees, including storage of patient samples and shipping of samples to other locations for use or storage. These fees will be paid by the patient according to current fees published on ReproTech, Ltd.website (
- RTL will provide storage of cryopreserved ovarian tissue dedicated for research at no charge.
- Marketing
Ovarian tissue
ReproTech has developed a brochure aimed at newly diagnosed cancer and other patients and oncology staff. RTL also has a continually evolving web site and website marketing, as well as oncology center visits and informational mailings to area oncologists. These materials will direct patients to the Freezing Center Network on RTL’s website ( or Additionally, patients will be referred to Freezing Center Network members when infertility services are needed.
III. [ENTER CENTER ABBR] Responsibilities
1. Scheduling and Paperwork
- [ASK FOR CENTER CODE]will require all of their patients to complete ReproTech forms prior to transfer of the tissue to ReproTech.
- [ASK FOR CENTER CODE] will provide ReproTech with completed “packets” of ReproTech forms, which ReproTech provided and the patients have completed, including witnessed signatures on appropriate forms.
- [ASK FOR CENTER CODE] staff will work with ReproTech staff to schedule Tissue shipping.
- [ASK FOR CENTER CODE]will provide ReproTech with all infectious disease testing, and a written donor eligibility determination for each tissue. It is understood and agreed that all patients will be tested and screened according to current state and federal laws governing anonymous reproductive tissue donors of leukocyte rich tissues.These test results will be made available to ReproTechbefore shipping the tissues to ReproTech.
- [ASK FOR CENTER CODE] will obtain all data required for reproductive tissue donor eligibility determination (i.e., screening, physical examination, history of high risk behavior/exposure and sexually transmitted disease testing). [ASK FOR CENTER CODE] will provide RTL with copies of said data and information prior to transfer of cryopreserved ovarian tissue to RTL. RTL cannot ensure that the data and information provided to RTL, prior to specimen transfer, will be sufficient to permit the use of oocytes resulting from cryopreserved ovarian tissue in a known or directed tissueor oocyterecipient or the patient herself.
2. Specimen Transfer protocol
- [ASK FOR CENTER CODE] will provide designated staff to be involved in the specimen transfers to ensure a smooth process.
- [ASK FOR CENTER CODE] will transfer all of the cryopreserved ovarian tissue from each patient including both the tissue owned by the patient (80%) and that dedicated to research (20%) unless instructed otherwise in writing by the Director of the National Physicians Cooperative (in consultation with the Oncofertility Consortium Steering Committee).
- [ASK FOR CENTER CODE] will provide ReproTech with copies of the laboratory records including the freezing data, labeling information for all specimens and RTL’s completed Specimen Transfer Data form, which documents the data for the specimen(s) transferred.
IV. Indemnification
Each party shall hold the other party harmless for actions performed by the other party.
Agreed to by:
______
National Physicians Cooperative (NPC) of the Oncofertility Center
at[ENTER CENTER NAME]
______
Its
______
Date
______
ReproTech, Ltd.
______
Its
______
Date
Note:All changes in this agreement require the approval of the National Physicians Cooperative Director and ReproTech, Ltd.
Please sign two (2) copies and return both to:
Brent Hazelrigg
President and CEO
ReproTech, Ltd.
18 South Ninth Street #201
Columbia, MO 65201
573-474-1756
A signed original will be returned to the person signing the agreement.
Please view disclaimer here: oncofertility.northwestern.edu/disclaimer
Version: 09/17/2014