Strategic Planning Facilitate the effective alignment of IT requirements/ Information Resource Management (IRM) plans with strategic business plans and program initiatives. Management Improvements: Development and implementation of improved systems and business practices to optimize productivity and service delivery operations (e.g., analysis, and implementation of improvements in the flow of IT work and program processes and tool utilization, including business system analysis, identification of requirements for streamlining, re-engineering, or re-structuring internal systems/business processes for improvement, determination of IT solution alternatives, benchmarking).
Business Development Provide advice and assistance in business growth and development of Party B. 业务发展。对乙方的业务发展提供建议和协助。
General Scope Except for matters on which the Members’ approval is required by the Act or this Agreement, the Manager has full power, authority and discretion to manage and direct the Company’s business, affairs and properties, including the specific powers referred to in paragraph (b), below.
Strategy As an organization without operational services (fuel, maintenance, etc.), and in consideration that the majority of potential issues come from boat maintenance whereby the boats are personal property, the predominant strategy will be the minimization of on-site waste. With this approach, the organization will have minimal potential impact on the environment and reduce regulatory risk. To accomplish this, requirements will be established by policy, periodic communications shall occur, and audits will be utilized to provide feedback for improvement.
Regulatory Affairs From the point in time at which Novartis gives GW notice in writing that it wishes to take on responsibility for Regulatory Filings and Regulatory Approvals in the Territory, Novartis shall be responsible for all interactions with Regulatory Authorities in the Territory with respect to Regulatory Approvals as set forth in this Section 6.1, and including, filing and maintaining any required Regulatory Approvals, seeking necessary permits and/or scheduling or re-scheduling in controlled substance listings or de-scheduling of the Product from controlled substances listings in the Territory.
(a) Where required, Novartis (or its applicable Affiliate or Sublicensee) will be responsible for arranging for the Product to be scheduled in any applicable controlled substance schedule(s) in countries in the Territory. GW agrees, without additional consideration, to give all necessary consents, declarations and documentation as are reasonably required to implement the foregoing and to provide Novartis with all assistance reasonably requested by Novartis (including attending meetings with Regulatory Authorities in any such country) for the purpose of arranging for such scheduling.
(b) Subject to Section 6.1(g), Novartis (or its applicable Affiliate or Sublicensee) will file and hold all Regulatory Approvals for the Products in countries in the Territory in its own name and on its own behalf. Unless otherwise agreed by the Parties, within ten (10) Business Days following the Effective Date, GW will assign to Novartis all Regulatory Filings with any Regulatory Authority in the Territory at the Effective Date relating to any Product and Novartis will reimburse GW all fees paid by GW to Regulatory Authorities in such countries with respect to the submission of such Regulatory Filings. On request by Novartis, GW will deliver notices of such assignment to the applicable Regulatory Authorities. In addition, GW agrees to give all necessary consents, declarations and documentation as are reasonably required to implement the foregoing.
(c) Subject to Sections 4.2 and 6.1(e), Novartis (or its applicable Affiliate or Sublicensee) will be responsible for conducting, at its sole expense, such activities directed towards obtaining and maintaining Regulatory Approvals for Products in the Territory as it determines appropriate in its sole discretion; provided, however, that Novartis agrees to submit Regulatory Filings for Marketing Approvals for a Product in each of the Key Countries. Thereafter, Novartis shall, on a Key Country-by-Key Country basis further prosecute all such Regulatory Filings in the Key Countries in a timely, professional and diligent manner, including by paying all required filing fees promptly and responding to correspondence and requests for further information from Regulatory Authorities in the Key Countries within a reasonable timeframe. Novartis shall share with GW its plans for obtaining Regulatory Approvals in the Key Countries at the first JSC meeting and thereafter shall supply GW with its updated plan from time to time. Novartis shall report its performance against this regulatory plan to the JSC each Calendar Quarter.
(d) Novartis will: (A) determine the regulatory plans and strategies for the Products in the Territory; (B) (either itself or through its Affiliates or Sublicensees and subject to Section 6.1(g)) make and own all Regulatory Filings with respect to the Products in the Territory; and (C) will be responsible for obtaining and maintaining Regulatory Approvals with respect to the Products in the Territory in the name of Novartis or its Affiliates or Sublicensees. Accordingly:
(i) Novartis, shall at its own cost write, assemble, otherwise prepare and file all Regulatory Filings required to obtain Regulatory Approvals for Products in the Territory;
(ii) Novartis shall be the principal contact with all Regulatory Authorities on all matters pertaining to any Product, but shall consult regularly with GW regarding such matters, giving due regard to GW’s views;
(iii) Novartis shall provide to GW copies of all substantive correspondence with Regulatory Authorities in the Territory related to any Product, and, to the extent practicable, shall consult with GW in advance of submitting any material correspondence related to any Product to any such Regulatory Authority;
(iv) GW shall provide to Novartis copies of all substantive correspondence with the EMA related to any Product and, to the extent practicable, shall consult with Novartis in advance of submitting any material correspondence related to any Product to the EMA in circumstances where such correspondence could reasonably be expected to impact on the Commercialization and/or Regulatory Approvals of any Product in the Territory;
(v) Novartis shall provide such notice to GW as is reasonably practicable under the circumstances of upcoming meetings related to any Product with Regulatory Authorities in the Territory. Subject to the consent of the relevant Regulatory Authority, GW shall be entitled to attend any such meetings as an observer, and Novartis may require GW’s attendance at any such meeting it deems to be potentially material; and
(vi) Novartis shall pay all filing and maintenance costs of Regulatory Filings and Regulatory Approvals for the Product in the Territory during the Term.
(e) GW shall, without additional consideration, fully cooperate with and provide assistance to Novartis in connection with filings to any Regulatory Authority relating to the Product(s) in the Territory in order to obtain or maintain Regulatory Approvals (including Pricing and/or Reimbursement Approvals, where applicable), including by (i) providing Novartis with an electronic copy of the registration dossier for the Product in the European Union as well as providing Novartis with an electronic copy of this registration dossier in eCTD format if and when available in eCTD format, and upon request by Novartis, an electronic copy of a draft of the registration dossier for the Product in the US as soon as such draft is made available to GW (if this draft is made available to GW in eCTD format GW will provide it to Novartis in eCID format); (ii) upon request by Novartis, providing Novartis with draft responses to any requests from Regulatory Authorities in the Territory related to the Development or manufacture of Products (including any requests related to the chemistry manufacturing and controls (CMC) section of any Regulatory Filing); and (iii) executing any required documents, providing access to personnel and providing Novartis with copies of all reasonably required documentation. To the extent requested by Novartis, GW shall also grant or cause to be granted to Novartis and its Affiliates or Sublicensees, within thirty (30) days of receipt of a written request from Novartis, cross-reference rights to any relevant drug master files and other filings submitted by GW or its Affiliates with any Regulatory Authority and any Regulatory Approval for Product issued by any Regulatory Authority to GW or its Affiliates.
(f) Subject to Novartis having access to reimbursement data from outside the Territory, data generated by Novartis for reimbursement shall be available for GW and its ex-Territory licensees of the Products to use with respect to the Products outside the Territory.
(g) In the event that (A) it is not possible under applicable Laws for Novartis to file for or hold Regulatory Approvals for the Product in any country in the Territory and/or (B) if requested by Novartis in writing to do so, to the extent permitted by applicable Laws and for the duration determined by Novartis, GW will file and/or hold all Regulatory Approvals for the Products in such country, at Novartis’s cost and expense (provided that all such costs and expenses shall be in accordance with a plan and budget agreed in writing by the Parties prior to GW making any such Regulatory Filing), and:
(i) GW will be responsible for, and will use diligent efforts in, obtaining and maintaining all Regulatory Approvals necessary for the Commercialization of the Products in the country in question;
(ii) GW will provide to Novartis copies of all substantive written communications between GW (or its Affiliates) and any Regulatory Authority in the Territory relating to any Product;
(iii) Novartis shall have the right to review and comment upon any Regulatory Filings and correspondence from GW (or its Affiliates) to any Regulatory Authority in the Territory relating to any Product, and GW shall incorporate or address all such comments unless otherwise agreed between the Parties;
(iv) GW will request and seek to arrange such meetings and consultations with Regulatory Authorities in the Territory which may be requested by Novartis, with respect to any Product;
(v) To the extent permitted by the relevant Regulatory Authorities, Novartis shall have the right to have representatives of Novartis attend and participate in all meetings between GW (or its Affiliates) and any Regulatory Authority in the Territory relating to any Product; it being understood and agreed that to the extent permitted by the relevant Regulatory Authorities, Novartis will lead discussions with any such Regulatory Authority in the Territory. If the applicable Regulatory Authority does not permit Novartis to lead any such discussion, GW will lead the applicable discussions as directed by Novartis; and
(vi) Novartis will reimburse GW any and all costs incurred pursuant to the foregoing and in accordance with the agreed plan and budget as follows. Within thirty (30) days after each Calendar Quarter during which GW has incurred any such costs and expenses, GW will provide to Novartis a detailed accounting of all such costs and expenses, and shall submit an invoice to Novartis substantially in the form of Exhibit C with respect to the amount of such costs and expenses. Unless disputed, Novartis shall pay such amount within sixty (60) days after receipt of such invoice.
(h) Novartis hereby grants, and undertakes to cause its Affiliates and Sublicensees to grant, to GW and its Affiliates cross-reference rights to any Regulatory Filing for Product submitted by Novartis or its Affiliates or Sublicensees to any Regulatory Authority in the Territory and any Marketing Approval for Product issued by any Regulatory Authority in the Territory to Novartis or its Affiliates or Sublicensees. Novartis shall also grant such cross-reference rights to those of GW’s licensees of the Products for countries outside the Territory for which Novartis, its Affiliates and Sublicensees are granted corresponding cross-reference rights.
(i) The Parties will discuss at the JSC the appropriate response to any request received by either Party from a Third Party academic institution to conduct any investigator initiated clinical study of a Product in the Territory.
(j) If any information comes into GW’s Control that requires a change to the CMC section of Regulatory Filings or Regulatory Approvals, inside and outside the Territory, to avoid ‘regulatory drift’ GW will inform Novartis in writing of the required change (including by providing the necessary technical documentation in English) and Novartis will file such documentation with the relevant Regulatory Authorities as soon as practicable.
1General Nothing in this Agreement shall prevent a Party from utilizing the services of any subcontractor as it deems appropriate to perform its obligations under this Agreement; provided, however, that each Party shall require its subcontractors to comply with all applicable terms and conditions of this Agreement in providing such services and each Party shall remain primarily liable to the other Parties for the performance of such subcontractor.
Selection Planning Prior to the issuance to consultants of any requests for proposals, the proposed plan for the selection of consultants under the Project shall be furnished to the Association for its review and approval, in accordance with the provisions of paragraph 1 of Appendix 1 to the Consultant Guidelines. Selection of all consultants’ services shall be undertaken in accordance with such selection plan as shall have been approved by the Association, and with the provisions of said paragraph 1.
Investment Strategy The Company’s investment strategy described in the Registration Statement and the Prospectus accurately reflect in all material respects the current intentions of the Company with respect to the operation of the Company’s business, and no material deviation from such investment strategy is currently contemplated.
PROMOTIONS AND STAFF CHANGES 11.01 Job Postings
a) When a vacancy occurs or a new position is created for a regular position which the Employer has decided to fill it shall be posted on all bulletin boards for five (5) working days and filled within forty (40) working days of the posting closing. Positions may be advertised in the media only after the Employer has determined an internal applicant is not the successful applicant. Where the Employer decides not to fill a vacant position, the Employer will provide an explanation to the Union if so requested.
b) The Employer, on a temporary basis, may fill a posted position during the posting and selection period.
c) For temporary positions of up to forty-two (42) days, a posting is not required. Positions of longer than forty-two (42) days (seventy-eight (78) days only in the case of temporary aquatic program positions) shall be posted except where the vacancy is created by the absence of an Employee due to vacation.
d) If a temporary position is made into a regular position, the new regular position shall be posted at least 14 days prior to the end of the temporary position.
(i) A posting shall include the following information: Nature of position, qualifications, skills, required knowledge and education, current shift hours and days, number of hours of work per week, and wage rate.
(ii) Such qualifications may not be established in an arbitrary or discriminatory manner, and shall reflect the contents of the Job Description.
11.02 Role of Seniority in Appointments, Promotions, Demotions and Transfers
a) Both parties recognize the principle of promotion within the service of the Employer in the bargaining unit
(i) For classifications required by their job description to supervise other employees in the bargaining unit listed in XXX#4, appointments, promotions, demotions, and transfers shall be based on the ability, knowledge, qualifications and seniority of the Regular Employees considered. Where the ability, qualifications and knowledge of the applicants are relatively equal, the senior applicant will be the successful candidate.
(ii) For all other classifications, where the ability, qualifications and knowledge are sufficient to perform the functions of the posted position, the senior applicant shall be appointed.
c) If the position is not filled by a Regular Employee in (i) or (ii) above, the ability and qualifications of Casual, Temporary and Seasonal Employees shall be considered, and if relatively equal, the senior applicant as determined in Article 10.05 shall be appointed.
d) If the position is not filled by an Employee in b (i), (ii), or c) above, all other applicants shall be considered.
General Management In the discharge of its general duty to manage the successful performance of the Services, Vendor shall:
3.2.1.1. within thirty (30) calendar days of the Effective Date, identify to Citizens the primary and secondary management contacts responsible for the oversight and management of Services for Citizens;
3.2.1.2. ensure Vendor Staff tasked with management and oversight of the Services are available promptly to perform Services during Business Hours;
3.2.1.3. ensure each assigned Adjuster submits a time record directly to Vendor’s manager or point of contact. At any time during this Agreement, Citizens may require copies of time records from Vendor;
3.2.1.4. ensure that no Vendor Staff carries a weapon on their person while performing Services;
3.2.1.5. ensure that no Vendor Staff uses impairing drugs, chemicals, or alcohol while performing Services;
3.2.1.6. ensure that Vendor Staff avoid using their duties and obligations under this Agreement to engage in any conduct that could create either an actual or perceived conflict of interest, such as due to an ongoing business relationship with an entity other than Citizens that would enable Vendor Staff to receive an improper benefit or unfair competitive advantage;
3.2.1.7. ensure that the Services comply with the Best Claims Practices & Estimating Guidelines as applicable to each Service Category and any other policies or processes set forth by Citizens, including but not limited to:
a. monitoring applicable file production on a weekly basis to determine compliance with Citizens’ production requirements; and,
b. providing detailed reports to Citizens related to Vendor performance upon request.
