Medical Affairs. Lian shall provide medical and scientific support for the Licensed Product in the Field in the Territory in order to ensure physicians are familiar on how to inject the product. Lian shall, subject to Applicable Laws, conduct such activities in compliance with its internal policies on engaging and sponsoring healthcare providers.
Medical Affairs. Development of a strong base of key opinion leaders will be critical to the success of BL-1040. Cardiology is a fast moving, highly technical field, and for Ikaria to be a credible player we will need to make a significant commitment to supporting the medical community through education, research support, etc. The European Medical Affairs team will take the lead in formulating strategy for the engagement of key opinion leaders in the formulation of brand development strategy, the development of brand champions and building high-level relationships between Ikaria and the medical community. The HQ Medical Affairs team will work closely with LOC Medical Affairs teams to align strategy across Europe and ensure a consistent medical approach. The HQ Medical Affairs team will also be responsible for development of health outcome data to support cost-effectiveness arguments. The HQ team will work closely with LOC commercial teams to package health outcome data for effective presentation to in-country prescribers and reimbursement decision makers. The HQ Medical Affairs team will also take responsibility for developing responses to requests for medical information about Ikaria products. The team will work with LOC Commercial and Medical Affairs teams to ensure a high level of customer support and satisfaction. Anticipated headcount: 3
Medical Affairs. Maintenance of a strong relationships and robust medical affairs response capability will be essential for success at the local level. The LOC medical director will take responsibility for development of strong local relationships, coordination of company response to medical information requests. Clinical Specialists in each LOC will be responsible for training of physicians on use of product and for customer service. Anticipated headcount: 1-2 Regulatory Affairs (RA) The LOC RA team will work together with HQ RA teams to execute on regulatory strategies and maintain product registrations with local authorities. Anticipated headcount: 1-2 Finance The HQ team will perform most of the finance functions on behalf of the European Area, with LOCs having minimal local requirement for finance headcount. Anticipated headcount: None Information Technology Ikaria’s European IT requirements will be delivered by the European HQ team, with local support from 3rd-party contract services. Anticipated headcount: None SCHEDULE 4.3(a) BIOLINERX WIRE TRANSFER INFORMATION Bank Name: [**] Bank Address: [**] SWIFT Number: [**] IBAN Number: [**] Account Number: [**] Account Name: [**] EXHIBIT A TECHNOLOGY EXCHANGE PLAN Upon Ikaria’s request, the following will be provided by BioLineRx to Ikaria or its designee:
Medical Affairs. Zai shall be solely responsible, at its sole cost and expense, for conducting medical affairs activities with respect to the Products in the Territory, including communications with key opinion leaders, medical education, symposia, advisory boards (to the extent related to medical affairs or clinical guidance), publications, congress presentations and posters, published manuscripts, activities performed in connection with patient registries and post-approval trials, and other medical programs and communications, including educational grants, research grants (including conducting investigator-initiated studies), and charitable donations to the extent related to medical affairs and not to other activities that do not involve the promotion, marketing, sale, or other Commercialization of the Products, all of which shall be conducted in accordance with Applicable Law. Zai shall update the JSC at each regularly scheduled JSC meeting regarding Zai’s medical affairs activities. Each such update shall be in a form to be agreed by the JSC and shall summarize Zai’s, its Affiliates’ and Sublicensees’ significant Commercialization activities with respect to the Products in the Territory, covering subject matter at a level of detail reasonably required by TPTX and sufficient to enable TPTX to determine Zai’s compliance with its diligence obligations pursuant to Section 8.1. In addition, Zai shall make available to TPTX such additional information about its Commercialization activities as may be reasonably requested by TPTX from time to time. All updates and reports generated pursuant to this Section 8.8 shall be the Confidential Information of Zai.
Medical Affairs. Sandoz shall employ a sufficient number of qualified medical personnel to perform any duties related to the Commercialization of the Products that require specific medical qualifications and shall comply with this Agreement and all agreements entered into pursuant to this Agreement. Sandoz shall provide any medical information on any Product requested by customers and all users thereof. Such medical information shall consider the registration status of the Products, available scientific information and shall be provided in a manner consistent with applicable Laws and a form and in format appropriate for the target audience and as instructed by KLOX. “[***] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 under the Securities Act of 1933, as amended”
Medical Affairs. Each Party shall be responsible for conducting its and its Affiliates’ own Medical Affairs Activities for Optioned Products in its Respective Territory at its sole cost and expense except to the extent any such costs and expenses are Shared Commercialization Costs.
Medical Affairs. 7.7.1 VIVUS shall be responsible for all Medical Affairs Activities during the Term, and with respect to the Territory. In the event the Term is extended, KADMON shall reimburse VIVUS on a Calendar Quarterly basis for 50% of the Medical Affairs Costs attributable to any KADMON Target.
Medical Affairs. Acura will be responsible for Medical Affairs for no more than three months after the Effective Date, according to a timeline established by the JSC. Thereafter, such responsibility will be assumed by Egalet.
Medical Affairs. Licensee shall be responsible for Medical Affairs in the Territory, with Akebia’s cooperation, support and assistance.
Medical Affairs. Zai shall be solely responsible, at its sole cost and expense, for conducting medical affairs activities with respect to the Products in the Territory, including communications with key opinion leaders, medical education, symposia, advisory boards (to the extent related to medical affairs or clinical guidance), publications, congress presentations and posters, published manuscripts, activities performed in connection with patient registries and post-approval trials, and other medical programs and communications, including educational grants, research grants (including conducting investigator-initiated studies), and charitable donations to the extent related to medical affairs and not to other activities that do not involve the promotion, marketing, sale, or other Commercialization of the Products, all of which shall be conducted in accordance with Applicable Law. Zai shall update the JSC at each regularly scheduled JSC meeting regarding Zai’s medical affairs activities. All updates and reports generated pursuant to this Section 8.7 shall be the Confidential Information of Zai.
