Human Leukocyte Antigen Testing This plan covers human leukocyte antigen testing for A, B, and DR antigens once per member per lifetime to establish a member’s bone marrow transplantation donor suitability in accordance with R.I. General Law §27-20-36. The testing must be performed in a facility that is: • accredited by the American Association of Blood Banks or its successors; and • licensed under the Clinical Laboratory Improvement Act as it may be amended from time to time. At the time of testing, the person being tested must complete and sign an informed consent form that also authorizes the results of the test to be used for participation in the National Marrow Donor program.
Clinical 1.1 Provides comprehensive evidence based nursing care and individual case management to a specific group of patients/clients including assessment, intervention and evaluation.
1.2 Undertakes clinical shifts at the direction of senior staff and the Nursing Director including participation on the on-call/after-hours/weekend roster if required.
1.3 Responsible and accountable for patient safety and quality of care through planning, coordinating, performing, facilitating, and evaluating the delivery of patient care relating to a particular group of patients, clients or staff in the practice setting.
1.4 Monitors, reviews and reports upon the standard of nursing practice to ensure that colleagues are working within the scope of nursing practice, following appropriate clinical pathways, policies, procedures and adopting a risk management approach in patient care delivery.
1.5 Participates in xxxx rounds/case conferences as appropriate.
1.6 Educates patients/carers in post discharge management and organises discharge summaries/referrals to other services, as appropriate.
1.7 Supports and liaises with patients, carers, colleagues, medical, nursing, allied health, support staff, external agencies and the private sector to provide coordinated multidisciplinary care.
1.8 Completes clinical documentation and undertakes other administrative/management tasks as required.
1.9 Participates in departmental and other meetings as required to meet organisational and service objectives.
1.10 Develops and seeks to implement change utilising expert clinical knowledge through research and evidence based best practice.
1.11 Monitors and maintains availability of consumable stock.
1.12 Complies with and demonstrates a positive commitment to Regulations, Acts and Policies relevant to nursing including the Code of Ethics for Nurses in Australia, the Code of Conduct for Nurses in Australia, the National Competency Standards for the Registered Nurse and the Poisons Act 2014 and Medicines and Poisons Regulations 2016.
1.13 Promotes and participates in team building and decision making.
1.14 Responsible for the clinical supervision of nurses at Level 1 and/or Enrolled Nurses/ Assistants in Nursing under their supervision.
Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.
Development Milestone Payments (i) In addition to the Closing Date Merger Consideration (less the Remaining Option Consideration and Rights Proceeds Amount, if any) and any Net TNF Sales Payments (as defined below), upon the attainment of the development ** Portions of the Exhibit have been omitted and have been filed separately pursuant to an application for confidential treatment filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended. milestones set forth below (each, a “Development Milestone”), Parent shall, or shall cause the Surviving Corporation to, [**] after the occurrence of each Development Milestone, deliver to the Paying Agent (for further payment to the holders of Stock Certificates and Stock Agreements outstanding immediately prior to the Effective Time), via wire transfer of immediately available funds, the respective amounts set forth below minus, in each case, the applicable Contingent Consideration Distribution Fee associated therewith and any amount designated by the Stockholders’ Representatives to be placed in the Administrative Expense Account (each, a “Development Milestone Payment” and collectively, the “Development Milestone Payments”):
(A) Upon FDA approval of Reslizumab for the treatment of eosinophilic esophagitis, a cash payment of [**];
(B) Upon marketing authorization of Reslizumab for the treatment of eosinophilic esophagitis being granted by the European Commission in accordance with Regulation (EC) No. 726/2004, a cash payment of [**];
(C) If Res 5-0010 Asthma Study Completion has not occurred on or prior to the Closing Date, then upon the occurrence of the Res 5-0010 Asthma Study Completion, a cash payment of $50,000,000 (fifty million dollars) (the “Res 5-0010 Asthma Payment”);
(D) Upon FDA approval of Reslizumab for any asthma indication, a cash payment of [**];
(E) Upon marketing authorization of Reslizumab for the treatment of any asthma indication being granted by the European Commission in accordance with Regulation (EC) No. 726/2004, a cash payment of [**]; and
(F) Upon FDA approval of an Oral Anti-TNF Product, a cash payment of [**].
Development Milestones In addition to its obligations under Paragraph 7.1, LICENSEE specifically commits to achieving (either itself or through the acts of a SUBLICENSEE) the following development milestones in its diligence activities under this AGREEMENT: (a) (b).
Tests and Preclinical and Clinical Trials The preclinical studies and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company, that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, as applicable, and are intended to be submitted to the U.S. Food and Drug Administration (the “FDA”) or other comparable government entities, were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Authorizations and Applicable Laws, including, without limitation, current Good Clinical Practices and Good Laboratory Practices and any applicable rules and regulations of the jurisdiction in which such trials and studies are being conducted; the descriptions of the results of such studies and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such studies and trials; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies or trials, the results of which the Company believes reasonably call into question the study or trial results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical stage of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, the Company has not received any written notices or written correspondence from the FDA or any governmental entity requiring the termination or suspension of any preclinical studies or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.
Presentation of Potential Target Businesses The Company shall cause each of the Initial Shareholders to agree that, in order to minimize potential conflicts of interest which may arise from multiple affiliations, the Initial Shareholders will present to the Company for its consideration, prior to presentation to any other person or company, any suitable opportunity to acquire an operating business, until the earlier of the consummation by the Company of a Business Combination or the liquidation of the Company, subject to any pre-existing fiduciary obligations the Initial Shareholders might have.
Hepatitis B Vaccine Where the Hospital identifies high risk areas where employees are exposed to Hepatitis B, the Hospital will provide, at no cost to the employees, a Hepatitis B vaccine.
Clinical Studies The animal and other preclinical studies and clinical trials conducted by the Company or on behalf of the Company were, and, if still pending are, to the Company’s knowledge, being conducted in all material respects in compliance with all Applicable Laws and in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical study and clinical trials of new drugs and biologics as applied to comparable products to those being developed by the Company; the descriptions of the results of such preclinical studies and clinical trials contained in the Registration Statement and the Prospectus are accurate and complete in all material respects, and, except as set forth in the Registration Statement and the Prospectus, the Company has no knowledge of any other clinical trials or preclinical studies, the results of which reasonably call into question the clinical trial or preclinical study results described or referred to in the Registration Statement and the Prospectus when viewed in the context in which such results are described; and the Company has not received any written notices or correspondence from the FDA, the EMA, or any other domestic or foreign governmental agency requiring the termination, suspension or modification of any preclinical studies or clinical trials conducted by or on behalf of the Company that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus.
Influenza Vaccine Upon recommendation of the Medical Officer of Health, all employees shall be required, on an annual basis to be vaccinated and or to take antiviral medication for influenza. If the costs of such medication are not covered by some other sources, the Employer will pay the cost for such medication. If the employee fails to take the required medication, she may be placed on an unpaid leave of absence during any influenza outbreak in the home until such time as the employee has been cleared by the public health or the Employer to return to the work environment. The only exception to this would be employees for whom taking the medication will result in the employee being physically ill to the extent that she cannot attend work. Upon written direction from the employee’s physician of such medical condition in consultation with the Employer’s physician, (if requested), the employee will be permitted to access their sick bank, if any, during any outbreak period. If there is a dispute between the physicians, the employee will be placed on unpaid leave. If the employee gets sick as a reaction to the drug and applies for WSIB the Employer will not oppose the application. If an employee is pregnant and her physician believes the pregnancy could be in jeopardy as a result of the influenza inoculation and/or the antiviral medication she shall be eligible for sick leave in circumstances where she is not allowed to attend at work as a result of an outbreak. This clause shall be interpreted in a manner consistent with the Ontario Human Rights Code.
