Manufacturing and Supply (a) Depomed shall supply Product for use in conducting Depomed’s development activities for Product in the Field and in the Territory as set forth in Exhibit D.
(b) During the four-year period beginning on the Effective Date (the “Supply Period”), Depomed shall supply and package (or have supplied and packaged) Product pursuant to this Section 4.8. Depomed will use commercially reasonable efforts to enter into a long-term Product supply agreement with [***] days after the Effective Date (the “Depomed Supply Agreement”) that will be freely assignable to Solvay or its Affiliates, successors or assigns at any time. In addition, Depomed and Solvay will negotiate and enter into a Product supply agreement with business terms substantially similar to the Depomed Supply Agreement concurrently with the execution and delivery by Depomed and [***] of the Depomed Supply Agreement (the “Solvay Supply Agreement”, and, together with the Depomed Supply Agreement, the “Supply Agreements”). The Supply Agreements will, together, contain the following provisions (among others mutually agreeable to the Parties):
(i) Under the Solvay Supply Agreement, Depomed will agree to supply Solvay with its requirements of finished, packaged Product during the Supply Period;
(ii) All manufacturing and records will be performed and maintained in accordance with specifications, cGMP and Applicable Law;
(iii) Depomed will provide reasonable assistance to Solvay in the event Solvay wishes to qualify a backup Product manufacturer;
(iv) Depomed shall [***];
(v) Solvay will pay Depomed the following amounts in connection with all activities performed by or on behalf of Depomed associated with Product manufacture and supply (other than activities specified on Exhibit D) (A) [***]% of Depomed’s out-of-pocket costs incurred in connection with such manufacture and supply of Product to Solvay, and (B) a labor charge equal to the FTE Charges for all Depomed employees allocated to the manufacture and supply of Product to Solvay, not to exceed FTE Charges for an aggregate of [***] during any given calendar quarter (and Depomed shall provide to Solvay periodic reports detailing the FTE Charges for which Solvay must pay Depomed hereunder);
Customer Focus Is dedicated to meeting the expectations and requirements of internal and external customers; gets first hand customer information and uses it for improvements in products and services; acts with customers in mind; establishes and maintains effective relationships with customers and gains their trust and respect Integrity and Trust Is widely trusted; is seen as a direct, truthful individual; can present the unvarnished truth in an appropriate and helpful manner; keeps confidences; admits mistakes; doesn’t misrepresent him/herself for personal gain. Drive For Results Can be counted on to exceed goals successfully; Is constantly and consistently one of the top performers; very bottom line oriented; steadfastly pushes self and others for results. Decision Quality Makes good decisions (without considering how much time it takes) based upon a mixture of analysis, wisdom, experience, and judgment; most of his/her solutions and suggestions turn out to be correct and accurate when judged over time; sought out by others for advice and solutions. Managing & Measuring Work Clearly assigns responsibility for tasks and decisions; sets clear objectives and measures; monitors process, progress, and results; designs feedback loops into work. Organisational Agility Knowledgeable about how organizations work; knows how to get things done both through formal channels and the informal network; understands the origin and reasoning behind key policies, practices, and procedures; understands the cultures of organizations. Interpersonal Savvy Relates well to all kinds of people – up, down, and sideways, inside and outside the organisation; builds appropriate rapport; builds constructive and effective relationships; uses diplomacy and tact; can defuse even high-tension situations comfortably. Motivating Others Creates a climate in which people want to do their best; can motivate many kinds of direct reports and team or project members; can assess each person and get the best out of him/her; pushes tasks and decisions down; empowers others; invites input from each person and shares ownership and visibility; makes each individual feel his/her work is important; is someone people like working for and with. • Directors of Nursing • Patients, families and whānau • Clinical Nurse Specialists • LMC Access Holders • Integrated Operations Centre • Other service providers (DHBs, NGOs, PHO) • Clinical Directors/Clinical Leaders • Health and Welfare Agencies • Service Managers • Relevant Support Groups • Other Charge Nurse Managers/Charge Midwife Managers/Unit Managers • University of Otago School of Medicine, Otago and Southland Polytechnics • Practice Development Unit staff • Professional Colleges and Registration Bodies • Clinical and Corporate support staff • SDHB wide staff The expertise required for a person to be fully competent in the role. Position specific competencies: ESSENTIAL DESIRABLE Education and Qualifications (or equivalent level of learning) • Registered Nurse/Midwife. • Holds a current practising certificate. • Holds a current portfolio (PDRP/QLP) or equivalent appropriate to the role. • Post-graduate diploma or degree in a relevant field. • Experience • Nursing leadership experience. • A history of a collaborative team approach. • Proven clinical credibility. • Extensive experience in the health sector. • Extensive experience of clinical quality and safety, best practice. • • Critical consumer of research and embraces evidenced based practice when carrying out tasks/functions. Knowledge and Skills • Strong clinical leadership and management skills. • Extensive knowledge of the health sector. • Extensive knowledge of clinical quality and safety, best practice. • Excellent group facilitation skills. • Advanced communication techniques such as conflict resolution, diffusion and mediation skills. • Knowledge of and demonstrated use of adult teaching and learning principles. • Personal Qualities • Commitment and personal accountability. • Excellent interpersonal skills, including ability to work effectively with people at all levels of the organisation. • Acts with discretion, sensitivity and integrity at all times. • Is adaptable and flexible – open to change (positive or negative). • Innovative and flexible with a positive problem solving approach in all situations. • Maintains an exceptionally high level of confidentiality. • Forward thinker, flexible, courteous, self-motivated. • Committed to continuous quality improvement. • Ability to liaise and network at all levels. • A reasonable level of fitness is required to cope with the demanding physical requirements of the job. The following denote the key physical requirements for the position: standing, walking, bending, sitting, stairs, simple grasping, fine manipulation, operating machinery/equipment, lifting, overhead reaching, carrying, pushing/pulling, twisting, climbing/balancing, crouching/squatting, manual handling of people, other reaching, and ability to participate in personal restraint if required. Clinical Leadership Xxxxxx a culture that strives for excellence in clinical service provision within allocated resources. • Promote excellence in clinical service provision through the sharing of new knowledge, ideas, and research. • Encourage innovation and practice initiatives that enhance clinical care or service provision. • Maintain a high standard of clinical expertise within the xxxx/unit. • Xxxxxx the development of a cohesive team which works collaboratively to achieve optimal patient/ service outcomes. • Be active and visible within the team, motivating and actively praising/valuing staff endeavours, and acknowledging patient satisfaction and good clinical care. • Promote patient/client centred care that incorporates a strong customer service philosophy through effective and positive interactions with patients/ clients, staff, visitors and other agencies. • Ensure clinical practice is provided within accepted professional standards, codes, policies and relevant legislation. • Ensure Treaty of Waitangi principles and Tikaka best practice guidelines are fully integrated into practice. • Encourage a culture of continuous learning, positive critique of the status quo and use of evidence based practice. • Ensure there is adequate leadership and principles of direction and delegation are adhered to by all staff. Service Planning and Delivery Lead and manage wards/units to provide efficient and effective services. Participate in and lead where relevant, xxxx/ unit service planning. • Lead and manage respective wards/units/services in accordance with operational plans and budgets. • Ensure a consumer/patient service focus is adopted and maintained at all xxxx/unit/service team level. • Implement Southern District Health Board wide policies and processes. • Ensure service delivery complies with Health and Disability sector standards and relevant legislation. • Actively participate in the preparation of service activity plans. • In conjunction with the Associate Director of Nursing/ Director of Nursing/Service Manager ensure service planning and delivery complies with Ministry of Health elective service performance indicator standards (where applicable). • Ensure adherence to the SDHB delegations of authority. • Effectively utilise Southern District Health Board information systems and data to enable xxxx/unit/ service patient care management and human resource utilisation activities. • Identify, lead and manage projects to improve xxxx/ unit/service efficiency and effectiveness. • Lead the team to effectively ensure discharge processes are robust and support the needs of the service, including timeliness, and staff responsibility in efficient discharge planning. • Build and maintain effective relationships and communication mechanisms with staff, associated clinical and support services, and external agencies as applicable. • Develop and implement audit care pathways in conjunction with clinical staff. • Ensure integrated care plans are utilised in clinical service delivery. • Facilitate and champion the integration of the SDHB Team based model of nursing practice. • Monitor xxxx/unit/service performance against key performance indicator targets, identifying and implementing corrective actions as and if required in conjunction with the Associate Director of Nursing/ Director of Nursing/Service Manager. • Prepare accurate monthly management reports for the xxxx/unit including variance analysis of key performance indicators, balanced scorecard and financial management variances together with corrective actions. • Prepare business cases and/or reports as requested/ required by the Associate Director of Nursing/Director of Nursing/ Service Manager. Staff Management and Planning Ensure the service/s is/are appropriately staffed. Best practice human resource standards are met. Effectively lead and manage assigned staff in order to develop and maintain a cohesive and productive team. Ensure effective communication within service. • Lead by example acting as a positive, motivating and inspiring role model for all staff. • Model sound Human Resource practice and, facilitate coaching and performance development for staff, in consultation with Human Resources and the Associate Director of Nursing/Director of Nursing/Service Manager; facilitate change management as appropriate. • Ensure effective recruitment, orientation, preceptorship, rostering and administration of staff in accordance with Southern District Health Board policies. • Develop a comprehensive staffing plan for staff directly reporting to the CNM/MM that recognises potential shortcomings and identifies strategies to address gaps both short and long term. • Ensure professional staff practice with a current annual practising certificate and logs in the appropriate reporting system. • Ensure rosters are developed in accordance with approved core roster resource levels and SDHB Rostering Standards and budgets. • Ensure appropriately budgeted training and development plans are in place for all staff. In conjunction with the ACN/CNS/Practice Development • Develop communication mechanisms that facilitate effective and timely communication within and across the xxxx/s and/or unit/s. • Proactively plan and implement appropriate staffing aligned with variations in patient/staff activity, e.g. winter, Christmas, school holidays. • Ensure timely staff appraisal and feedback structures are in place. With staff, identify professional development plans aligned to SDHB and service priorities. • Proactively deal with staff conflict and performance issues. • Ensure effective strategies are in place to resolve issues. • Maximise opportunities to create a harmonious working environment. Show positive leadership and seek feedback. • Manage employee leave to ensure service demands are matched with the legal requirements for staff to take leave. • Ensure accuracy and timeliness in rostering and payroll transactions in compliance with OneStaff (staff management system) and the SDHB Rostering Standards Unit Nurse Educator, and ensure in-service training and education is carried out to maintain quality of service. • Promote and facilitate nursing staff participation in the PDRP (Professional Development Recognition Programme). • Ensure all staff have an up to date annual leave management plan at all times. Financial Management Work within budgets for the financial year, and work in collaboration with the Associate Director of Nursing/Director of Nursing/Service Manager to develop risk mitigation strategies for unexpected expenditure. Participate in developing and managing annual and three year capital expenditure plan. • Report to the Associate Director of Nursing/Director of Nursing/Service Manager on a monthly basis, financial performance including variations and corrective actions. • Work closely with Analyst to understand variances and operationalise mitigating strategies. • Participate in annual budgeting process with Associate Director of Nursing/Director of Nursing/Service Manager and Analyst. Report to the Associate Director of Nursing/Director of Nursing/Service Manager on a monthly basis, financial performance including variations and corrective actions. • Work closely with Analyst to understand variances and operationalise mitigating strategies. • Participate in annual budgeting process with Associate Director of Nursing/Director of Nursing/Service Manager and Analyst. • Manage capital expenditure within annual capital expenditure plans, and in accordance with SDHB policies and procedures. • Proactively engage with staff to identify ideas and action plans for xxxx/unit efficiency improvements and cost reduction initiatives. Quality and Risk Management Manage xxxx/unit quality and risk programmes. Lead and manage certification and accreditation within xxxx/unit. Xxxxxx a quality improvement culture. • Lead, administer and facilitate staff involvement in xxxx/unit quality and risk programmes and action plans, and participate in service wide programmes, in accordance with Southern District Health Board policy. • Lead and manage service level health and safety programmes including audit of hazards and routine reporting of incidents and accidents. • Investigate complaints, incidents and other matters in a timely manner, reporting outcomes as required • Ensure compliance including: all relevant standards and legislation, health safety, professional regulations, and equipment. • Manage xxxx/unit balanced scorecard and report and manage variations. • Lead the xxxx/unit incident reporting and investigation processes, within SDHB policies and procedures. • Support and demonstrate the philosophy and practice of a service and organisational wide systems approach to service and operational processes. including development of action plans to facilitate xxxx/unit/ service development. • Proactively develop new xxxx/unit/service policies and protocols in conjunction with members of the team. • Maintain professional and organisational quality standards. • Ensure delivered work is planned, delivered, and implemented consistently against quality standards. • Continuously identify improvement opportunities to perform job in most effective manner. • Investigate opportunities to achieve goals in a more efficient way. • Lead and support the implementation of the Releasing Time to Care programme for the xxxx/unit/ service. • Performance is in alignment with HR quality audit standards, organisational requirements, and professional standards. • Lead the roll out and continual update of visual management boards for the xxxx/unit/service which displays key elements of performance for staff and patients. Strategic Management Contribute and lead xxxx/unit operational and clinical projects. Lead in the process of change and instil a continuous quality improvement culture. • Maintain knowledge of current and emerging strategic priorities for the relevant service grouping specialties. • Lead assigned projects that are of strategic xxxx/unit & service priority, ensuring their effective completion within assigned timeframes and resources. • Build a collective vision for the xxxx/unit to allow staff to have a clear understanding of their role in service provision. • Use Balanced Scorecard, incidents, complaints and other KPIs to inform xxxx/unit development and improvement opportunities • Participates in SDHB wide projects as relevant to xxxx/unit/service. • Participate in focus groups/projects that advance issues and strategies for the organisation. • Provide cover for other CNM/CMM/UM within the service as required. • Act up as Associate Director of Nursing/Director of Nursing/Service Manager as required/requested. • Participate collectively with other CNM/CMM to provide a collaborative approach to provide clinical service provision. • Plan and manage own work to achieve desired results on time, within budget and to required standard. • Act as a role model for the SDHB organisational values.
Supplier A manufacturer, fabricator, distributor, supplier, or vendor of goods or equipment in connection with the Work, or any other party having a Contract or Purchase Order with the Contractor or with a Subcontractor to furnish materials or equipment to be incorporated in the Work by the Contractor or a Subcontractor.
Product ACCEPTANCE Unless otherwise provided by mutual agreement of the Authorized User and the Contractor, Authorized User(s) shall have thirty (30) days from the date of delivery to accept hardware products and sixty (60) days from the date of delivery to accept all other Product. Where the Contractor is responsible for installation, acceptance shall be from completion of installation. Failure to provide notice of acceptance or rejection or a deficiency statement to the Contractor by the end of the period provided for under this clause constitutes acceptance by the Authorized User(s) as of the expiration of that period. The License Term shall be extended by the time periods allowed for trial use, testing and acceptance unless the Commissioner or Authorized User agrees to accept the Product at completion of trial use. Unless otherwise provided by mutual agreement of the Authorized User and the Contractor, Authorized User shall have the option to run testing on the Product prior to acceptance, such tests and data sets to be specified by User. Where using its own data or tests, Authorized User must have the tests or representative set of data available upon delivery. This demonstration will take the form of a documented installation test, capable of observation by the Authorized User, and shall be made part of the Contractor’s standard documentation. The test data shall remain accessible to the Authorized User after completion of the test. In the event that the documented installation test cannot be completed successfully within the specified acceptance period, and the Contractor or Product is responsible for the delay, Authorized User shall have the option to cancel the order in whole or in part, or to extend the testing period for an additional thirty (30) day increment. Authorized User shall notify Contractor of acceptance upon successful completion of the documented installation test. Such cancellation shall not give rise to any cause of action against the Authorized User for damages, loss of profits, expenses, or other remuneration of any kind. If the Authorized User elects to provide a deficiency statement specifying how the Product fails to meet the specifications within the testing period, Contractor shall have thirty (30) days to correct the deficiency, and the Authorized User shall have an additional sixty (60) days to evaluate the Product as provided herein. If the Product does not meet the specifications at the end of the extended testing period, Authorized User, upon prior written notice to Contractor, may then reject the Product and return all defective Product to Contractor, and Contractor shall refund any monies paid by the Authorized User to Contractor therefor. Costs and liabilities associated with a failure of the Product to perform in accordance with the functionality tests or product specifications during the acceptance period shall be borne fully by Contractor to the extent that said costs or liabilities shall not have been caused by negligent or willful acts or omissions of the Authorized User’s agents or employees. Said costs shall be limited to the amounts set forth in the Limitation of Liability Clause for any liability for costs incurred at the direction or recommendation of Contractor.
PRODUCT MANUFACTURER'S SUPPLIERS Only those dealers/distributors listed by the manufacturer will be considered authorized to act on behalf of the Product Manufacturer.
Manufacture and Supply As between the Parties, Otsuka shall be responsible for, shall bear all costs associated with, and shall have all decision-making authority over, all Manufacturing Activities (subject to discussion of CMC matters with Acucela through the JDC or applicable Operating Team as discussed below); provided, that Otsuka shall supply Licensed Product to Acucela or its permitted subcontractors for use in clinical trials conducted in accordance with each Development Plan and, if applicable, Commercialization Plan (i.e., Phase 3b Clinical Trials or Post-Approval Studies, if any), free of charge and in such quantities as are agreed by the JDC or the JCC (as applicable) or are otherwise required to seek or obtain Regulatory Approval. In addition, if and after Acucela exercises an Opt-In Right under Section 3.1, Otsuka shall supply promotional samples of Licensed Product to Acucela for use in its performance of Co-Promotion, in such quantities and on such terms as are determined by the JCC. The cost of promotional samples of Licensed Product, which shall be included in Commercialization Costs, shall be established by the JCC based on Otsuka’s per-unit cost to manufacture such promotional samples (but, for the avoidance of doubt, Otsuka shall have no obligation to disclose any information relating to its manufacturing costs), but in no event shall such promotional sample cost exceed * per promotional sample unless mutually agreed otherwise by the Parties. Acucela’s and its permitted subcontractors’ obligations to conduct Development activities, and upon Acucela’s exercise of its Opt-in Right pursuant to Section 3.1, to conduct Development and Commercialization activities, shall be expressly conditioned upon Otsuka fulfilling its Licensed Product supply obligations as set forth in the Development Plan or the Commercialization Plan, as applicable. To the extent that Otsuka reasonably believes is necessary for performance of Development or Commercialization, Otsuka agrees to keep Acucela reasonably informed from time to time, through the JDC, JCC or applicable Operating Team, regarding the general status of Manufacturing Activities related to the Licensed Product (including Other Indication Product(s), as applicable) and from time to time shall update Acucela on any foreseeable delays and/or other material issues relating to Manufacturing the Licensed Product (including Other Indication Product(s), as applicable). Through the JDC or applicable Operating Team, Otsuka and Acucela shall confer and discuss CMC matters, and Otsuka agrees to consider suggestions of Acucela regarding CMC matters.
Other Products and Services As our customer, you have access to a suite of financial products and services availed by ourselves, our affiliates and strategic partners designed to help you address and achieve your financial needs and goals. You agree that you can obtain information about such Products and Services via our website xxx.xxxxxxxx.xxx.xx and you further agree that we can from time to time communicate information in relation to such Products or Services to you specifically or generally to all cardmembers via such communication mode as we consider appropriate.
Third Party Products and Services Any third-party hardware, software and/or services that is delivered by ResMed for use either standalone or in conjunction with ResMed products and/or services, shall be subject to the third-party terms and conditions and/or license agreements between Customer and the third party. Such third-party hardware, software and/or services is provided by ResMed "AS IS," without any warranty of any kind. Any representations or warranties as to such hardware, software and/or services shall only be as granted by the applicable third parties, if any, that accompany such products and/or software and/or services. Any representations, warranties, or other similar obligations with respect to such third-party hardware, software and/or services flow directly from the third party to Customer and ResMed shall have no responsibility at all for any such representations, warranties, obligations or lack thereof.
New Products You agree to comply with NASD Notice to Members 5-26 recommending best practices for reviewing new products.
Customer The agency or eligible user that purchases commodities or contractual services pursuant to the Contract.
