FDA Matters As to each product subject to the jurisdiction of the U.S. Food and Drug Administration (“FDA”) under the Federal Food, Drug and Cosmetic Act, as amended, and the regulations thereunder (“FDCA”) that is manufactured, packaged, labeled, tested, distributed, sold, and/or marketed by the Company or any of its Subsidiaries (each such product, a “Pharmaceutical Product”), such Pharmaceutical Product is being manufactured, packaged, labeled, tested, distributed, sold and/or marketed by the Company in compliance with all applicable requirements under FDCA and similar laws, rules and regulations relating to registration, investigational use, premarket clearance, licensure, or application approval, good manufacturing practices, good laboratory practices, good clinical practices, product listing, quotas, labeling, advertising, record keeping and filing of reports, except where the failure to be in compliance would not have or reasonably be expected to result in a Material Adverse Effect. There is no pending, completed or, to the Company’s knowledge, threatened, action (including any lawsuit, arbitration, or legal or administrative or regulatory proceeding, charge, complaint, or investigation) against the Company or any of its Subsidiaries, and none of the Company or any of its Subsidiaries has received any notice, warning letter or other communication from the FDA or any other governmental entity, which (i) contests the premarket clearance, licensure, registration, or approval of, the uses of, the distribution of, the manufacturing or packaging of, the testing of, the sale of, or the labeling and promotion of any Pharmaceutical Product, (ii) withdraws its approval of, requests the recall, suspension, or seizure of, or withdraws or orders the withdrawal of advertising or sales promotional materials relating to, any Pharmaceutical Product, (iii) imposes a clinical hold on any clinical investigation by the Company or any of its Subsidiaries, (iv) enjoins production at any facility of the Company or any of its Subsidiaries, (v) enters or proposes to enter into a consent decree of permanent injunction with the Company or any of its Subsidiaries, or (vi) otherwise alleges any violation of any laws, rules or regulations by the Company or any of its Subsidiaries, and which, either individually or in the aggregate, would have or reasonably be expected to result in a Material Adverse Effect. The properties, business and operations of the Company have been and are being conducted in all material respects in accordance with all applicable laws, rules and regulations of the FDA. The Company has not been informed by the FDA that the FDA will prohibit the marketing, sale, license or use in the United States of any product proposed to be developed, produced or marketed by the Company nor has the FDA expressed any concern as to approving or clearing for marketing any product being developed or proposed to be developed by the Company.
TRAINING AND RELATED MATTERS The parties recognise that in order to increase the efficiency and productivity of the company a significant commitment to structured training and skill development is required. Accordingly the parties commit themselves to:
a) The parties to this Agreement recognise the importance of the apprenticeship system to the construction industry. It is agreed that every employer party to this Agreement who employs five (5) or more tradespersons in any one classification shall undertake to employ at least one (1) apprentice or make arrangements to host an apprentice from an agreed group apprenticeship scheme. Where an employer does not currently have an apprentice as per this provision, reasonable time shall be allowed to enable the employer to comply with this clause. Further, the parties are committed to a strong ratio of apprentices in the industry. Apprenticeship levels on a specific project may be discussed at the Project Pre-Commencement Conference (refer Clause 16).
b) Providing employees with the opportunity to acquire additional skills within relevant career path structures through appropriate structured training based on nationally endorsed (i.e. Construction Training Australia endorsed) competency standards and curriculum;
c) Actively encouraging employees to seek formal recognition of their skills (i.e. recognition of prior learning); and
d) Using training providers accredited and acceptable to the parties. The CFMEU, MBAV and other employer associations are legitimately engaged in providing training to industry and it is hereby agreed that all parties will properly recognise and accept the validity of nationally accredited training as provided by the other parties.
e) The parties will consult on the development of training programs which are consistent with the following: • Training provided will be consistent with the company’s business requirements, relevant to the work of the employees, consistent with the skills development of each employee and with applicable national competency standards. • Training may be taken either on or off the job with all reasonable steps being taken to conduct training in normal working hours. • If an approved training activity is undertaken during ordinary working hours, the employee/s concerned shall not suffer any loss of pay. • Approved training activities undertaken outside of ordinary hours will be paid at single time or will, at the employee’s option, be taken as time off in lieu of payment. Provided that the scheduling of time off must be consistent with the needs of the business and be by agreement with the company. • Training costs of courses approved by the company will be met by the company. • The company will not be asked to meet the costs of training undertaken by employees which was not approved by the company. • Leave of absence granted pursuant to this clause shall count as service for all purposes of the award and this agreement. • Accredited members of the union will be allowed up to 5 days per year, without loss of pay, to attend trade union educational courses conducted or approved by the union. (see appendix H)
f) The parties to this Agreement recognise the importance of the role that Apprentices/Trainees fulfill within the industry and, more importantly, a role that they will fulfill as trades persons following the conclusion of the indentures. To this end the Victorian Building Industry Consultative Committee will investigate ways of enhancing employment prospects for Apprentice/Trainees. In addition it is agreed that, where appropriate, employers will use their best endeavours to employ Apprentices/Trainees in order to ensure appropriate trade persons levels for the future.
