New Lines of Therapy Sample Clauses

New Lines of Therapy. Subject to Section 3.1(c)(i)(3) below, in the event that BMS/BMKK (as one party) or Merck/MJ (as the other party) (the “Interested Party”) wishes to initiate a Clinical Trial program, and thereafter seek Approval, for a new line of therapy within either a new, or an existing approved (for example, second line therapy once third line therapy has been approved), Indication for Final Product in Japan, and the other Party (BMS/BMKK or Merck/MJ) does not, subject to Section 3.1(c)(i)(3), wish to amend the Long-Term Development Plan to include the activities necessary to seek Approval in Japan for such new line of therapy in Japan (the “Non-Interested Party”), then the Interested Party shall have the right, but not the obligation, to conduct such Clinical Trial program and to perform all other Confidential Treatment has been requested by ImClone Systems Incorporated for portions of this document. necessary activities to seek and obtain Approval for such specific new line of therapy for Final Product in Japan, at the Interested Party’s sole cost and expense, provided that if the SCJ by majority vote reasonably determines that there are good grounds to believe that the proposed course of activities are reasonably likely to be significantly detrimental to the product profile or marketing of Final Product for any one or more Indications or lines of therapy that have been previously approved (or that have been previously filed and are awaiting regulatory approval) in Japan (by way of example, and without limitation, because the proposed protocol is poorly designed or is likely to yield poor results), or to materially adversely impact the Commercialization of Final Product in the EU or the U.S., or that the proposed course of activities presents a medical risk/benefit that is so unfavorable as to be incompatible with the welfare of patients, then the Interested Party shall not proceed. The Interested Party shall be entitled to cross-reference any data generated or controlled by a Non-Interested Party anywhere in the world in support of such new line of therapy for Development and registration of same in Japan. (1) Subject to Section 3.1(c)(i)(4), in the event the Interested Party obtains Approval for such additional line of therapy within a given Indication, and there are no other lines of therapy within such Indication that (x) have been approved by the Japanese Regulatory Authorities and (y) BMKK and MJ are then Co-Promoting, then the Interested Party, but not the N...
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Related to New Lines of Therapy

  • Dialysis Services This plan covers dialysis services and supplies provided when you are inpatient, outpatient or in your home and under the supervision of a dialysis program. Dialysis supplies provided in your home are covered as durable medical equipment.

  • Speech Therapy This plan covers speech therapy services when provided by a qualified licensed • loss of speech or communication function; or • impairment as a result of an acute illness or injury, or an acute exacerbation of a chronic disease. Speech therapy services must relate to: • performing basic functional communication; or • assessing or treating swallowing dysfunction. See Autism Services when speech therapy services are rendered as part of the treatment of autism spectrum disorder. The amount you pay and any benefit limit will be the same whether the services are provided for habilitative or rehabilitative purposes.

  • Innovative Scheduling Schedules which are inconsistent with the Collective Agreement provisions may be developed in order to improve quality of working life, support continuity of resident care, ensure adequate staffing resources, and support cost-efficiency. The parties agree that such innovative schedules may be determined locally by the Home and the Union subject to the following principles: (a) Such schedules shall be established by mutual agreement of the Home and the Union; (b) These schedules may pertain to full-time and/or part-time employees; (c) The introduction of such schedules and trial periods, if any, shall be determined by the local parties. Such schedules may be discontinued by either party with notice as determined through local negotiations; (d) Upon written agreement of the Home and the Union, the parties may agree to amend collective agreement provisions to accommodate any innovative unit schedules; (e) It is understood and agreed that these arrangements are based on individual circumstances and each agreement is made on a without prejudice or precedent basis. (f) It is understood and agreed that these arrangements can be utilized for temporary job postings for seasonal coverage (e.g. weekend workers, etc.).

  • Telemedicine Services This plan covers clinically appropriate telemedicine services when the service is provided via remote access through an on-line service or other interactive audio and video telecommunications system in accordance with R.I. General Law § 27-81-1. Clinically appropriate telemedicine services may be obtained from a network or non- network provider, and from our designated telemedicine service provider. When you seek telemedicine services from our designated telemedicine service provider, the amount you pay is listed in the Summary of Medical Benefits. When you receive a covered healthcare service from a network or non-network provider via remote access, the amount you pay depends on the covered healthcare service you receive, as indicated in the Summary of Medical Benefits. For information about telemedicine services, our designated telemedicine service provider, and how to access telemedicine services, please visit our website or contact our Customer Service Department.

  • Radiation Therapy/Chemotherapy Services This plan covers chemotherapy and radiation services. This plan covers respiratory therapy services. When respiratory services are provided in your home, as part of a home care program, durable medical equipment, supplies, and oxygen are covered as a durable medical equipment service.

  • Termination of Therapy Therapist reserves the right to terminate therapy at his/her discretion. Reasons for termination include, but are not limited to, untimely payment of fees, failure to comply with treatment recommendations, conflicts of interest, failure to participate in therapy, Patient needs are outside of Therapist’s scope of competence or practice, or Patient is not making adequate progress in therapy. Patient has the right to terminate therapy at his/her discretion. Upon either party’s decision to terminate therapy, Therapist will generally recommend that Patient participate in at least one, or possibly more, termination sessions. These sessions are intended to facilitate a positive termination experience and give both parties an opportunity to reflect on the work that has been done. Therapist will also attempt to ensure a smooth transition to another therapist by offering referrals to Patient.

  • Connectivity User is solely responsible for providing and maintaining all necessary electronic communications with Exchange, including, wiring, computer hardware, software, communication line access, and networking devices.

  • 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.

  • Diagnostic procedures to aid the Provider in determining required dental treatment.

  • Activation We will notify the Xxxxxx of your request to receive electronic billing information. The presentment of your first electronic bill may vary from Xxxxxx to Xxxxxx and may take up to sixty (60) days, depending on the billing cycle of each Xxxxxx. While your electronic bill feature is being activated it is your responsibility to keep your accounts current. Each electronic Xxxxxx reserves the right to accept or deny your request to receive electronic bills.

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