Master Cell Line Issues-Cooperation Sample Clauses

Master Cell Line Issues-Cooperation. Dynavax and RBNV acknowledge that the Master Cell Line is (1) used by RBNV and its Affiliates for the production of products that are approved by Governmental Authorities, and that are currently on the market, and (2) is confidential and of crucial importance to the Parties. Accordingly, [ * ] ensure the best and most informed approach. To avoid any doubt, [ * ] Dynavax and RBNV further agree to use reasonable efforts to promptly notify the other party of any and all communications to and from Governmental Authorities relating to the safety of the Master Cell Line, as well as of any communication and/or concerns expressed by such regulatory authority relating to the safety, quality or characterization of the Master Cell Line, and agree to consult promptly with each other to resolve any such concerns with the FDA or such other Governmental Authorities. The Parties agree to share all safety, toxicity and tumorogenicity data regarding the Master Cell Line that any of them (or their Affiliates) generates (or receives or contracts for) [ * ]
AutoNDA by SimpleDocs

Related to Master Cell Line Issues-Cooperation

  • Technical Cooperation In order to facilitate the implementation of this Agreement, developed country Members shall provide, on request and on mutually agreed terms and conditions, technical and financial cooperation in favour of developing and least-developed country Members. Such cooperation shall include assistance in the preparation of laws and regulations on the protection and enforcement of intellectual property rights as well as on the prevention of their abuse, and shall include support regarding the establishment or reinforcement of domestic offices and agencies relevant to these matters, including the training of personnel.

  • Economic Cooperation 1. The Parties will encourage the utilization of cooperation instruments and mechanisms with a view to strengthen the processes of economic integration and commercial exchange. 2. The objectives of economic cooperation will be: (a) to build on existing agreements or arrangements already in place for trade and economic cooperation; and (b) to advance and strengthen trade and economic relations between the Parties. 3. The Parties will encourage and facilitate, as appropriate, the following activities, including, but not limited to: (a) dialogue about policies and regular exchanges of information and views on ways to promote and expand trade in goods and services between the Parties; (b) joint elaboration of studies and technical projects of economic interest according to the economic development needs identified by the Parties; (c) keeping each other informed of important economic and trade issues, and any impediments to furthering their economic cooperation; (d) providing assistance and facilities to business persons and trade missions that visit the other Party with the knowledge and support of the relevant agencies; (e) supporting dialogue and exchanges of experience among the respective business communities of the Parties; (f) establishing and developing mechanisms for providing information and identifying opportunities for business cooperation, trade in goods and services, investment, and government procurement; and (g) stimulating and facilitating actions of public and/or private sectors in areas of economic interest.

  • Audit Cooperation In the event either Party is audited by a taxing authority, the other Party agrees to cooperate fully with the Party being audited in order to respond to any audit inquiries in a proper and timely manner so that the audit and/or any resulting controversy may be resolved expeditiously.

  • Industrial cooperation Cooperation shall aim to promote the modernisation and restructuring of industry and individual sectors in Serbia. It shall also cover industrial cooperation between economic operators, with the objective of strengthening the private sector under conditions which ensure that the environment is protected. Industrial cooperation initiatives shall reflect the priorities determined by both Parties. They shall take into account the regional aspects of industrial development, promoting trans-national partnerships when relevant. The initiatives should seek in particular to establish a suitable framework for undertakings, to improve management, know-how and to promote markets, market transparency and the business environment. Special attention shall be devoted to the establishment of efficient export promotion activities in Serbia. Cooperation shall take due account of the Community acquis in the field of industrial policy.

  • Scope of Cooperation 1. The Authorities recognise the importance of close communication concerning the Covered CCPs and intend to cooperate regarding: a) general issues, including with respect to regulatory, supervisory, enforcement or other developments concerning the Covered CCPs and Australia; b) issues relevant to the operations, activities and services of the Covered CCPs; c) the coordination of supervisory activities and, where appropriate and consistent with applicable laws and each Authority’s mandate, providing assistance in the implementation of enforcement decisions; d) any other areas of mutual interest. 2. The Authorities recognise in particular the importance of close cooperation in the event that a Covered CCP, particularly one whose failure likely would be systemically important to an Authority, experiences, or is threatened by, a potential financial crisis or other Emergency Situation. One or both of the Local Authorities should provide notification to ESMA, and ESMA should provide notification to the Local Authorities, consistent with Article 3(4) below and each Authority should keep the other Authorities appropriately informed throughout the Emergency Situation. The Local Authorities should coordinate and lead in an Emergency Situation and should consult with and take account of the views of ESMA to the greatest extent practicable. ESMA should coordinate with the relevant CBI(s) regarding an Emergency Situation of a Covered CCP and any emergency measures that the CBI may consider appropriate. 3. Cooperation will be most useful in circumstances where issues of regulatory, supervisory or enforcement concern may arise, including but not limited to: a) the initial application of a Covered CCP for recognition in the European Union pursuant to Article 25 of EMIR and the periodic reviews of its recognition pursuant to Article 25(5) of EMIR; b) ESMA’s assessment of compliance and monitoring of the ongoing compliance by a Covered CCP with the Recognition Conditions; c) the tiering determination of a Covered CCP by ESMA pursuant to Article 25(2a) of EMIR; d) changes in a Covered CCP's internal rules, policies and procedures that could affect the way in which the Covered CCP complies with any Recognition Conditions; e) regulatory, supervisory or enforcement actions or approvals taken by a Local Authority or ESMA in relation to a Covered CCP, including changes to the relevant obligations and requirements to which the Covered CCPs are subject that may impact the Covered CCPs' continued compliance with the Recognition Conditions; and f) changes to regulatory status or requirements that could result in a change in the regulatory status of, relief granted to, or supervisory treatment of a Covered CCP and potentially could disrupt cross-border clearing arrangements.

  • Information Systems Acquisition Development and Maintenance a. Client Data – Client Data will only be used by State Street for the purposes specified in this Agreement.

  • Areas of Cooperation 1. To achieve the objectives of cooperation in fisheries within the described principles, cooperation will include fisheries management and conservation issues, vessel management and post harvest arrangements and financial and trade measures and development of fisheries and fisheries products and marine aquaculture. 2. The EC Party will contribute to the mobilisation of the resources for the implementation of the identified areas of cooperation at national and regional levels, which will also include support for regional capacity building. Furthermore, the EC Party contributes to the measures as described in the section concerning financial and trade measures, and on infrastructure development specific for fisheries and marine aquaculture.

  • Information/Cooperation Executive shall, upon reasonable notice, furnish such information and assistance to the Bank as may be reasonably required by the Bank, in connection with any litigation in which it or any of its subsidiaries or affiliates is, or may become, a party; provided, however, that Executive shall not be required to provide information or assistance with respect to any litigation between Executive and the Bank or any other subsidiaries or affiliates.

  • Cultural cooperation 1. The aims of cultural cooperation will be: (a) to build on existing agreements or arrangements already in place for cultural cooperation; and (b) to promote information and cultural exchanges between the Parties. 2. The Parties will encourage and facilitate, as appropriate, the following activities, including, but not limited to: (a) dialogue on cultural policies and promotion of local culture; (b) exchange of cultural events and promote awareness of artistic works; (c) exchange of experience in conservation and restoration of national heritage; (d) exchange of experience on management for the arts; (e) protecting archaeological monuments and cultural heritage; (f) having a consultation mechanism between the Parties' culture authorities; and (g) cooperation in the audio-visual field, mainly coproduction and training programs in this sector and means of communication, including training, development and distribution activities.

  • Regulatory Cooperation In connection with any foreclosure, collection, sale or other enforcement of Liens granted to the Administrative Agent in the Collateral Documents, Parent will, and will cause its Restricted Subsidiaries to, reasonably cooperate in good faith with the Administrative Agent or its designee in obtaining all regulatory licenses, consents and other governmental approvals necessary or (in the reasonable opinion of the Administrative Agent or its designee) reasonably advisable to conduct all aviation operations with respect to the Collateral and will, at the reasonable request of the Administrative Agent and in good faith, continue to operate and manage the Collateral and maintain all applicable regulatory licenses with respect to the Collateral until such time as the Administrative Agent or its designee obtain such licenses, consents and approvals, and at such time Parent will, and will cause its Restricted Subsidiaries to, cooperate in good faith with the transition of the aviation operations with respect to the Collateral to any new aviation operator (including, without limitation, the Administrative Agent or its designee).

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!