Clinical Supply Servier shall be primarily responsible for manufacturing and supplying bulk Licensed Oligos and finished Licensed Products for use in clinical studies conducted pursuant to the Development Plan in the Field in the Territory, provided that Servier may engage Miragen for such manufacture and supply as follows: At least 180 days prior to the anticipated filing of the first CTA for the first indication with respect to a Licensed Product, Servier shall notify Miragen in writing whether it desires to engage Miragen for such manufacture and supply. If Servier chooses to have Miragen provide such clinical supply, Servier and Miragen shall negotiate in good faith and enter into a separate supply agreement having mutually agreed terms with respect to such clinical supply, which supply shall be at Cost of Goods (except for Unsponsored Work, in which case the supply shall be at Cost of Goods plus [*]). For clarity, Miragen’s manufacturing-related Development costs, as described in Section 1.27(e), [*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. are not included in the Cost of Goods but shall be included in Development Plan Costs and shared by the Parties pursuant to Section 9.3. If Servier does not engage Miragen but elects to manufacture and supply bulk Licensed Oligos and finished Licensed Products for Development purposes, either through itself or its Third Party manufacturer, then Miragen shall have the right to purchase such bulk Licensed Oligos and finished Licensed Products from Servier at Cost of Goods (except for Unsponsored Work, in which case the supply shall be at Cost of Goods plus [*]), and the other terms and conditions to be agreed upon by the Parties and set forth in a separate supply agreement. For clarity, Miragen shall have the right to manufacture and have manufactured, anywhere in the world, the Licensed Oligos and Licensed Products for clinical and commercial use outside the Territory.
Commercial Supply i) Not later than ** before the anticipated first commercial sale of the Licensed Product in the Licensed Territory, the Parties shall commence good faith negotiations of a commercial supply agreement that shall govern the supply of Commercial Product to SymBio (the “Commercial Supply Agreement”), with a goal of entering into the Commercial Supply Agreement no later than ** prior to the anticipated first commercial sale of the Licensed Product in the Licensed Territory. Pursuant to the Commercial Supply Agreement, Onconova shall be obligated, by itself or through its Third Party contract manufacturer, to supply to SymBio, and SymBio shall be required to purchase, all quantities of the Commercial Product required by SymBio to commercialize the Licensed Product in the Licensed Territory. Such Commercial Supply Agreement shall be consistent with the terms set forth in this Article 5, and shall include customary and reasonable terms and conditions commonly accepted in the pharmaceutical industry for supply of similar products at similar scale. Without limiting the foregoing, the Commercial Supply Agreement shall contain rights for SymBio to audit the Actual Unit Cost periodically, an obligation for the Parties to enter into a quality agreement, backup rights for SymBio to manufacture Licensed Products and rights for SymBio to inspect facilities used to manufacture Commercial Product.
ii) Pursuant to the Commercial Supply Agreement, Onconova shall supply SymBio with the Commercial Product meeting the relevant Specifications, at a price equal to the “▇▇▇▇ Up,” which shall be defined as Onconova’s Actual Unit Cost for the Commercial Product plus **, provided that (i) in no event shall the ▇▇▇▇ Up exceed **, and further provided that in no event shall the sum of the price for supply of the Commercial Product to SymBio and the royalty payable pursuant to Section 15 with respect to the Commercial Product exceed **. The foregoing calculations shall be based on the average Japan Net Selling Price and U.S. Net Selling Price calculated for all units of Commercial Product sold in the calendar quarter preceding the calendar quarter in which Onconova invoices SymBio for Commercial Product. With respect to any supply of Commercial Product prior to the period during which the U.S. Net Selling Price and/or Japan Net Selling Price can be calculated, the Parties shall use an estimated U.S. Net Selling Price and/or Japan Net Selling Price, as applicable, for purposes of calculating the ▇▇▇▇ Up.
Durable Medical Equipment (DME), Medical Supplies, Prosthetic Devices, Enteral Formula or Food, and Hair Prosthesis (Wigs) This plan covers durable medical equipment and supplies, prosthetic devices and enteral formula or food as described in this section. DME is equipment which: • can withstand repeated use; • is primarily and customarily used to serve a medical purpose; • is not useful to a person in the absence of an illness or injury; and • is for use in the home. DME includes supplies necessary for the effective use of the equipment. This plan covers the following DME: • wheelchairs, hospital beds, and other DME items used only for medical treatment; and • replacement of purchased equipment which is needed due to a change in your medical condition or if the device is not functional, no longer under warranty, or cannot be repaired. DME may be classified as a rental item or a purchased item. In most cases, this plan only pays for a rental DME up to our allowance for a purchased DME. Repairs and supplies for rental DME are included in the rental allowance. Medical supplies are consumable supplies that are disposable and not intended for re- use. Medical supplies require an order by a physician and must be essential for the care or treatment of an illness, injury, or congenital defect. Covered medical supplies include: • essential accessories such as hoses, tubes and mouthpieces for use with medically necessary DME (these accessories are included as part of the rental allowance for rented DME); • catheters, colostomy and ileostomy supplies, irrigation trays and surgical dressings; and • respiratory therapy equipment. This plan covers diabetic equipment and supplies for the treatment of diabetes in accordance with R.I. General Law §27-20-30. Covered diabetic equipment and supplies include: • therapeutic or molded shoes and inserts for custom-molded shoes for the prevention of amputation; • blood glucose monitors including those with special features for the legally blind, external insulin infusion pumps and accessories, insulin infusion devices and injection aids; and • lancets and test strips for glucose monitors including those with special features for the legally blind, and infusion sets for external insulin pumps. The amount you pay differs based on whether the equipment and supplies are bought from a durable medical equipment provider or from a pharmacy. See the Summary of Pharmacy Benefits and the Summary of Medical Benefits for details. Coverage for some diabetic equipment and supplies may only be available from either a DME provider or from a pharmacy. Visit our website to determine if this is applicable or call our Customer Service Department. Prosthetic devices replace or substitute all or part of an internal body part, including contiguous tissue, or replace all or part of the function of a permanently inoperative or malfunctioning body part and alleviate functional loss or impairment due to an illness, injury or congenital defect. Prosthetic devices do not include dental prosthetics. This plan covers the following prosthetic devices as required under R.I. General Law § 27-20-52: • prosthetic appliances such as artificial limbs, breasts, larynxes and eyes; • replacement or adjustment of prosthetic appliances if there is a change in your medical condition or if the device is not functional, no longer under warranty and cannot be repaired; • devices, accessories, batteries and supplies necessary for prosthetic devices; • orthopedic braces except corrective shoes and orthotic devices used in connection with footwear; and • breast prosthesis following a mastectomy, in accordance with the Women’s Health and Cancer Rights Act of 1998 and R.I. General Law 27-20-29. The prosthetic device must be ordered or provided by a physician, or by a provider under the direction of a physician. When you are prescribed a prosthetic device as an inpatient and it is billed by a provider other than the hospital where you are an inpatient, the outpatient benefit limit will apply. Enteral formula or food is nutrition that is absorbed through the intestinal tract, whether delivered through a feeding tube or taken orally. Enteral nutrition is covered when it is the sole source of nutrition and prescribed by the physician for home use. In accordance with R.I. General Law §27-20-56, this plan covers enteral formula taken orally for the treatment of: • malabsorption caused by Crohn’s Disease; • ulcerative colitis; • gastroesophageal reflux; • chronic intestinal pseudo obstruction; and • inherited diseases of amino acids and organic acids. Food products modified to be low protein are covered for the treatment of inherited diseases of amino acids and organic acids. Preauthorization may be required. The amount that you pay may differ depending on whether the nutrition is delivered through a feeding tube or taken orally. When enteral formula is delivered through a feeding tube, associated supplies are also covered. This plan covers hair prosthetics (wigs) worn for hair loss suffered as a result of cancer treatment in accordance with R.I. General Law § 27-20-54 and subject to the benefit limit and copayment listed in the Summary of Medical Benefits. This plan will reimburse the lesser of the provider’s charge or the benefit limit shown in the Summary of Medical Benefits. If the provider’s charge is more than the benefit limit, you are responsible for paying any difference. This plan covers Early Intervention Services in accordance with R.I. General Law §27- 20-50. Early Intervention Services are educational, developmental, health, and social services provided to children from birth to thirty-six (36) months. The child must be certified by the Rhode Island Department of Human Services (DHS) to enroll in an approved Early Intervention Services program. Services must be provided by a licensed Early Intervention provider and rendered to a Rhode Island resident. Members not living in Rhode Island may seek services from the state in which they reside; however, those services are not covered under this plan. Early Intervention Services as defined by DHS include but are not limited to the following: • speech and language therapy; • physical and occupational therapy; • evaluation; • case management; • nutrition; • service plan development and review; • nursing services; and • assistive technology services and devices.
Durable Medical Equipment (DME), Medical Supplies Prosthetic Devices, Enteral Formula or Food, and Hair Prosthesis (Wigs) • Items typically found in the home that do not need a prescription and are easily obtainable such as, but not limited to: o adhesive bandages; o elastic bandages; o gauze pads; and o alcohol swabs. • DME and medical supplies prescribed primarily for the convenience of the member or the member’s family, including but not limited to, duplicate DME or medical supplies for use in multiple locations or any DME or medical supplies used primarily to assist a caregiver. • Non-wearable automatic external defibrillators. • Replacement of durable medical equipment and prosthetic devices prescribed because of a desire for new equipment or new technology. • Equipment that does not meet the basic functional need of the average person. • DME that does not directly improve the function of the member. • Medical supplies provided during an office visit. • Pillows or batteries, except when used for the operation of a covered prosthetic device, or items for which the sole function is to improve the quality of life or mental wellbeing. • Repair or replacement of DME when the equipment is under warranty, covered by the manufacturer, or during the rental period. • Infant formula, nutritional supplements and food, or food products, whether or not prescribed, unless required by R.I. Law §27-20-56 for Enteral Nutrition Products, or delivered through a feeding tube as the sole source of nutrition. • Corrective or orthopedic shoes and orthotic devices used in connection with footwear, unless for the treatment of diabetes. • Treatments, procedures, facilities, equipment, drugs, devices, supplies, or services that are experimental or investigational except as described in Section 3. • Reversal of gender reassignment surgery.
Recall List The Board shall maintain a recall list. Copies of the list will be sent to each person on the list and the Association at least once during the fall and once during the spring each year.