Cryopreservation Program Participation Agreement and Informed Consent

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1 Cryopreservation Program Participation Agreement and Informed Consent This AGREEMENT is a contract made by and between Arizona Reproductive Medicine Specialists (ARMS) and Patient and (when applicable) Partner. Recitals Patient and partner wish to attempt a pregnancy by means of in vitro fertilization under ARMS Assisted Reproductive Technology (ART) Program and are enrolled therein. ARMS offers it s Cryopreservation Program (the Cryo Program or the program) to qualified ART patients as an option upon the terms and conditions of the Agreement.. The Cryo Program uses liquid nitrogen to freeze, and thereby preserve, human embryos. This procedure is available when embryos are created during an in vitro fertilization treatment cycle. The Cryo Program reduces the risk of multiple births, while creating opportunities for future pregnancy by transfer of concepti developed from frozen / thawed embryos, sometimes avoiding additional egg retrieval procedures. Patient and Partner hereby contract and elect to enter the Cryo Program, and give their informed consent to the procedures, as described below. Patient and Partner acknowledge that they have consulted or had opportunity to consult with such advisors as were necessary to enable them to decide to participate in the Cryo Program, to enter into this Agreement, and to sign the related consent forms. In consideration of the premises and the rights and obligations created hereunder, Patient and Partner and ARMS agree as follows: Part 1 Agreement 1. Patient and Partner agree that embryos provided by them in an ARMS in vitro fertilization treatment shall be used by ARMS in accordance with this Agreement. Embryos of suitable quality for freezing, as determined by ARMS, may be cryopreserved (frozen) at ARMS for the primary purpose of preserving them for later transfer by ARMS into the Patient. Cryopreserved embryos are called Cryopreserved Material for the purposes of this Agreement. Patient and Partner acknowledge that the Cryopreserved Material have no capacity to produce human life until the proper thawing and ascertainment of survival of the embryo has been performed and the embryo has been properly transferred into the Patient or another patient. Patient and Partner further agree to pay a storage fee, which may be adjusted from time to time by ARMS. It is Patient and Partner s responsibility to pay the current storage fees and notify ARMS of any change of address or phone number. Failure to do either can result in default of this contract and result in the specimens being declared as orphans and may be handled as outlined in termination of this contract (3B) and (4) below. 2. Neither Patient, Partner nor ARMS shall have any rights or obligations concerning the Cryopreserved Material except as expressly described in this Agreement. 1

2 3. ARMS will maintain and utilize or dispose of the Cryopreserved Material strictly as follows: A. So long as Patient and Partner continue participation in the ART and Cryo Programs, the Cryopreserved Material shall be stored exclusively (i) to preserve the opportunity of thawing it and (ii) for transfer by ARMS, of any resulting embryos into the Patient. Patient and Partner shall pay in a timely manner, ARMS prevailing charges for participation in the Cryo Program. It is the patient s responsibility to pay storage fees and they should not rely upon ARMS for billing. Unless otherwise directed (as for example, to thaw the Cryopreserved Material and transfer it to the Partner), ARMS shall store the Cryopreserved Material for a period of 3 years, except as otherwise provided herein or as extended by mutual agreement in writing. For further storage, a new contract must be initiated by Patient and Partner and executed. Failure to do this results in termination of this contract as outlined below in (3B) and (4). It shall be solely the Patient's and Partner's responsibility to keep ARMS notified of their current address and phone number, and to pay storage fees. It shall not be ARMS' responsibility to bill for these fees. B. Upon termination of Patient s and Partner s participation in the Cryo Program, as defined in Paragraph 4 below, all further charges for storage of the Cryopreserved Material shall cease, and title to the remaining Cryopreserved Material will pass to ARMS. At that time, and thereafter, ARMS shall use or dispose of the Cryopreserved Material in any one of the following ways, as directed by Patient and Partner on the Disposition of Embryos Declaration form included at the end of this document. (i) The Cryopreserved Material may be used for the benefit of another couple as donor embryos. Selecting this option effectively transfers the ownership of the cryopreserved material to ARMS upon termination of this agreement. ARMS may facilitate the donation of your cryopreserved material to any party at it s sole discretion. If ARMS is unable to facilitate the donation of your cryopreserved material to another party for any reason, it may thaw and discard your cryopreserved material at it s sole discretion. This selection is only active if you agree at the time of execution of this agreement to pay the prevailing shipping charges to transfer the cryopreserved material to a storage facility involved in the storage of cryopreserved material awaiting donation. If the prevailing shipping charges are not paid and documented on the Disposition of Cryopreserved material Declaration form, the cryopreserved material will be thawed and discarded upon termination of this contract. (ii) (iii) ARMS may make the Cryopreserved Material available for pathological examination, quality control or research and may not be used in any procedure that may result in a pregnancy (these embryos or sperm may be destroyed if specimens do not meet research criteria). ARMS may thaw and discard the Cryopreserved Material. 2

3 Regardless of the selections above, should the cryopreserved material not be suitable for any of the choices above, as determined by ARMS, the cryopreserved material will be discarded. Regardless of the decision (i) or (ii) above, ARMS maintains the right to discard any cryopreserved material that is not suitable for either embryo donation or research. Notwithstanding the foregoing, ARMS agrees to be governed, to the extent feasible, by any of the three foregoing ways selected by the Patient and Partner in a single writing signed by both of them in the presence of an authorized representative of ARMS, or notarized and received by ARMS at or before termination of their participation, as defined in Paragraph 4 below. C. If any court of competent jurisdiction shall award to either Patient or Partner all rights with respect to the Cryopreserved Material to the exclusion of the other spouse, by an order or decree which is final and binding as to them, then ARMS shall have the right thereafter, whether or not party to the proceedings giving rise to such order or decree, to deal exclusively with him or her to whom such rights were awarded ( the prevailing party ) without liability or other accountability to the other of them, and in such event may (a) release their Cryopreserved Material to the prevailing party if the prevailing party fulfills conditions (i) through (ii) of Paragraph 5 below, (b) agree with the prevailing party for termination of participation, (c) proceed with ART treatment under the direction of the prevailing party in any way agreeable to ARMS in conformity with the protocols and policies then in effect with respect to ART, or (d) comply in any other way with such decree. 4. Termination of the Patient s and Partner s participation shall occur upon: A. Affirmation withdrawal by Patient and Partner from the Cryo Program, which shall be deemed to occur upon ARMS by receipt of (i) a writing, signed by both Patient and Partner, requesting termination of participation, or (ii) a writing, signed by Patient or Partner, requesting termination of participation, together with a certified copy of an order entered by a court of competent jurisdiction, binding on both spouses, and authorizing the requesting spouse or either spouse to terminate participation. B. The lapse of 3 years from the date Cryopreserved Material is placed in storage by ARMS pursuant to this Agreement, unless said date is extended by mutual agreement of all parties hereto in writing. It shall be the Patient s and Partner s responsibility to renew this contract within ninety days of expiration of this contract. Expiration of the contract is defined as 3 years from the date the Cryopreserved Material was placed in storage by ARMS. C. Death of Patient or partner unless ARMS has received an agreement signed by both, that the Survivor could remain in the Program. D. Failure to pay prevailing charges of ARMS for storage of the Cryopreserved Material, if such failure continues for a period of ninety days from the date the payment was due to ARMS. Patient and partner are not to rely on ARMS for billing or notification of when payment is due. 3

4 E. Termination pursuant to Paragraph 5 below, when the Cryopreserved Material is transferred to another site. F. Failure to notify ARMS of a change of domicile after ninety days of change of domicile. 5. Patient and Partner acknowledge that ARMS, for medical reasons, recommends against the transporting of the Cryopreserved Material to any other facility or location. The parties hereto agree that ARMS only permit such transfer when the Patient and Partner (i) assume all risks and expenses, (ii) agree in writing to indemnify ARMS from all cost, expense and liability associated therewith, (iii) pay a fee of $750 or the then current charge in effect, for administrative and other costs (except when proceeding under Paragraph 6 below), (iv) are current in their financial account with ARMS, and (v) comply with such other conditions as ARMS may in its reasonable discretion impose. 6. It is intended that the Cryo Program operate indefinitely. However, ARMS reserves the right to discontinue the Cryo Program upon reasonable notice in the event that scientific, financial or other considerations lead it to do so. If ARMS discontinues the Cryo Program for any reason while Patient and Partner are participants therein and their Cryopreserved Materials are in storage with ARMS, ARMS shall give written notice of the discontinuance to the Patient and Partner by United States Mail sent to their latest address on file at ARMS. If the notice is returned for insufficient address or similar reason, or if no written response is received within ninety days after mailing, or if the response so provides, it is agreed that ARMS may in any such event proceed as though there has been a termination of participation under Paragraph 4F above. However, if Patient and Partner do respond to such notice in writing signed by both of them and received at ARMS within ninety days after mailing of the notice, ARMS will, if so requested in the response, release to Patient and Partner jointly their frozen Cryopreserved Material for transport elsewhere to a physician or clinic of their choice via approved portable container. Financial obligations of Patient and Partner to ARMS must be met prior to initiation of the transfer of Cryopreserved Material. All risks, costs, arrangements and expenses for such transport and for subsequent fate of the Cryopreserved Material shall be the sole responsibility of the Patient and Partner. Failure of Patient and Partner to perfect and carry out the arrangements for such transfer within ninety days after agreeing to do so shall revert the parties to the provisions of Paragraph 3B. 7. Patient and Partner have been informed of the medical probability of conceiving as a result of their participation in the program. No assurance has been, or can be, given as to achieving the pregnancy of the Partner. In consideration of being accepted in the Programs of ARMS, Patient and Partner waive, to the maximum extent permitted by law, any and all claims which they or either of them may hereafter be entitled to assert to recover damages from ARMS, or any personnel thereof, arising from their participation in the Cryo program including from the failure to achieve pregnancy, unless such claims result directly from the negligence or malfeasance of ARMS. 4

5 8. Patient and Partner agree to keep their most current mailing address on file at ARMS at all times during their participation in the Cryo Program and for one year thereafter, and to advise ARMS promptly, in writing upon each change of address or prolonged absence from the last address on file. Failure to do so, will result in termination of participation in the Cryo program as listed in 4,F. Unless and until superseded in writing, their current mailing address is the address shown on below. 9. Patient and Partner agree that prior to ARMS thawing Cryopreserved Material for transfer into the Patient, both Patient and Partner must sign a separate written consent addressed to ARMS, expressly requesting and authorizing the thawing and transfer for each attempt at achieving pregnancy. 10. If Patient and Partner or both of them shall make ARMS or any of their officers, employees or agents a party to any litigation arising from any disagreement between Patient and Partner as to the rights of either or both of them hereunder as to each other or as to ARMS, Patient and Partner shall be jointly and severally liable for the reasonable attorney s fees in such litigation and other costs of ARMS unless ARMS is found by a court of competent jurisdiction have (i) breached this Agreement, (ii) acted arbitrarily and capriciously so as to justify being a party to the legal proceedings, or (iii) committed a tort (wrong) against Patient and/or Partner. 5

6 11. In consideration of the foregoing and in reliance on the reasonable accuracy of information given by Patient and Partner in their application for the ART Program, ARMS accepts the Patient and Partner into their Cryo Program, subject to obtaining their informed consent. Signed Patient Partner Date By: ARMS Authorized Signatory Part II Informed Consent Cryopreservation of Human Embryos A. We (the undersigned Patient and Partner) understand that cryopreservation is a clinical procedure performed under the direction of physicians of the Cryo Program. It is designed to initiate a successful pregnancy after cryopreservation of human embryos. We understand that participation in this clinical procedure is voluntary. If we elect not to participate, our decision will not affect our relations with ARMS or result in any penalty or loss of benefits to which we are otherwise entitled. B. We have read this document carefully and know we should ask questions about anything, which is unclear before we decide whether to be participants in this procedure. We understand that Dr Moffitt (602) 343-ARMS (2767) or his designee will be happy to answer any of our questions. C. The Cryo Program is used in the event that we produce embryos during our IVF treatment cycle. Embryos suitable for cryopreservation, as determined by ARMS, will be cryopreserved. However, special situations can be discussed with our physician D. We further understand that this procedure is intended to benefit us personally by reducing the risk of multiple births and their obstetric complications, while at the same time creating opportunities for the initiation of pregnancy at a later date with the transfer of concepti developed from frozen/ thawed embryos. 6

7 E. Laboratories worldwide cryopreserve human embryos and establish pregnancies after transfer. Many babies have been born subsequent to the transfer of such frozen/ thawed embryos. Studies of human embryos and extensive investigations of cryopreserved animal embryos suggest no increase in risk of abnormalities in offspring that have been cryopreserved. This does not mean that cryopreservation eliminates the normal risk of obstetric complications or fetal abnormalities, but rather that cryopreservation does not appear to create an increased risk, although the possibility of a presently unforeseen risk cannot be completely eliminated. F. Any patient specific information obtained during these procedures that can be identified with us will remain confidential and will be described to individuals not connected with this project only with our written permission unless otherwise required by law. We understand and agree that photographs or videotapes may be taken of the embryos during the cryopreservation procedures as a permanent record and for possible use at medical meetings or with the lay public for educational purposes. We understand that we have the right to review these records at any time, and we authorize any appropriate government agency to do so. G. We understand that with any technique necessitating mechanical support systems, equipment failure can occur. Neither ARMS nor their directors, employees or consultants are to be held liable for any destruction, damage, or improper freezing, maintenance, storage, withdrawal, thawing and/or delivery caused by or resulting from any malfunction of the storage tank, failure of utilities, cessation of services or other labor disturbance, or other equipment failure, or other disturbance, any fire, wind, earthquake, water, or other acts of God. Patient s Signature Partner s Signature Date Date I have explained the above to Patient and Partner on the date stated on this consent form. Provider s Signature Date 7

8 DISPOSITION OF CRYOPRESERVED MATERIAL DECLARATION Arizona Reproductive Medicine Specialists 1701 E. Thomas Rd. Bldg. 1 Ste. 101 Phoenix, AZ 85006Ladies and Gentlemen: We hereby request that the Cryopreserved Material on hand at Arizona Reproductive Medicine Specialists, in the event of the termination of our participation in the Cryo Program, be disposed of in any of the ways we indicate below. (i) The Cryopreserved Material may be used for the benefit of another couple as donor embryos. We understand that electing this option effectively transfers the ownership of our cryopreserved material to ARMS upon termination of this agreement. ARMS may facilitate the donation of our cryopreserved material to any party at it s sole discretion. If ARMS is unable to facilitate the donation of our cryopreserved material to another party for any reason, it may thaw and discard our cryopreserved material at it s sole discretion. This selection is only active if payment of the prevailing charges is documented in the space provided below this section. If the prevailing charges are not paid and documented below, the cryopreserved material will be thawed and discarded upon termination of this contract. Staff Receiving payment: Payment Amount: Staff Signature: (ii) ARMS may make the Cryopreserved Material available for pathological examination, quality control or research and may not be used in any procedure that may result in a pregnancy (these embryos or sperm may be destroyed if specimens do not meet research criteria). (iii) ARMS may thaw and discard the Cryopreserved Material. Regardless of the selection above, ARMS maintains its right to discard any cryopreserved material ARMS determines not suitable for donation or research. Signed: Patient Witnessed by: Partner 8

9 Please Print Arizona Reproductive Medicine Specialists Representative Names of Patient and Partner Street Address City State Zip Code Home Phone Office Phone 9

10 Arizona Reproductive Medicine Specialists 1701 E. Thomas Rd. Ste 101 Phoenix, AZ (602) Ladies and Gentlemen: In exercise of the rights referred to in Paragraph 4 of our Cryopreservation Program Participation Agreement and Informed Consent dated, we hereby request that, in the event that one of us predeceases the other while any of our Cryopreserved Material remains in the care and custody of ARMS to the end that: (Please check the appropriate box) The surviving patient may, if she so chooses, have the Cryopreserved Material implanted in her uterus, transported to another site, or used/disposed of in accordance with the options of Paragraph 3B. We hereby elect that the survivor be permitted to remain in the Program and that the survivor shall have full control and custody of the Cryopreserved Material. Yes No The surviving partner may, if he so chooses, have the Cryopreserved Material transported to another site, or used/disposed of in accordance with the options of Paragraph 3B. We hereby elect that the survivor be permitted to remain in the Program and that the survivor shall have full control and custody of the Cryopreserved Material. Yes No Signed: Patient Partner Date Witness 10

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