Novartis Obligations Sample Clauses

Novartis Obligations. (a) Novartis will commence the Evaluation Studies promptly after Novartis’ receipt of the amounts of Evaluation Materials specified in Exhibit C as necessary to commence such studies and will use Commercially Reasonable Efforts to complete the Evaluation Studies during the Option Term. (b) Novartis will be responsible for compliance by itself and its Affiliates with all Applicable Laws with respect to the Evaluation Studies. (c) Novartis shall provide the Evaluation Committee with reports not later than [***] following the end of every other Calendar Quarter, in reasonable detail and in a mutually agreed-upon format, regarding the progress and results of the Evaluation Studies (each, a “Biannual Evaluation Report”). Each Biannual Evaluation Report shall include at a minimum information regarding (i) the number of active sites in each Evaluation Study, (ii) the number of patients enrolled in each Evaluation Study, (iii) any safety issues or adverse experiences of which Novartis has been notified or become aware during the course of conducting the Evaluation Studies and (iv) a high level summary of any findings that Novartis has discovered in the immediately preceding Calendar Quarter as well as an updated information package as described on Exhibit F hereto with respect to such Calendar Quarter. After delivery of each Biannual Evaluation Report to Evaluation Committee, the Evaluation Committee will meet to discuss the results. (d) Xxxxx shall provide the Evaluation Committee with a report two times per year, in reasonable detail and in a mutually agreed-upon format, regarding safety and manufacturing developments arising in Xxxxx’x Development efforts outside the Field that could potentially materially affect the Evaluation Studies. (e) Notwithstanding any termination of this Agreement, within [***] after the earlier of [***] following the last visit of the last subject in the Evaluation Studies (each as specified in the plan for the Evaluation Studies set forth in Exhibit C, as may be amended and reviewed by the Evaluation Committee) or the end of the Option Term (i.e., if the Evaluation Studies are not completed), Novartis will provide the Evaluation Committee with a final written report summarizing in reasonable detail the results of, and the performance of the Compound in, the Evaluation Studies (the “Final Evaluation Report”). (f) Notwithstanding the foregoing, the Biannual Evaluation Report and the Final Evaluation Report will not include any informat...
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Novartis Obligations. During the Non-Competition Period, Novartis shall not, and shall ensure that its Affiliates do not, either alone or in conjunction with a Third Party, directly or indirectly, market, sell or promote, or license any Third Party to market, sell or promote, any Competing Product anywhere in the world. Notwithstanding the foregoing, if Novartis or any of its Affiliates seeks, either alone or in conjunction with a Third Party, to, directly or indirectly, market, sell or promote, or license any Third Party to market, sell or promote, any Competing Product anywhere in the world (the "Competing Product Opportunity"), Novartis shall first provide written notice thereof to Idenix (the "Competing Product Opportunity Notice"), whereupon the provisions of Section 7.1(b) shall apply:
Novartis Obligations. 10.1.1 Novartis shall provide to Endo all data or other information reasonably requested by Endo concerning the manufacturing of Products in order to assist Endo in complying with the reporting requirements described in Section 10.2 below. Novartis shall do so at no cost to Endo; provided that in the event such request is with respect to an investigation, outside the ordinary course of business, or otherwise inconsistent with Endo's past practice, and in complying therewith Novartis would incur extraordinary expenses, Novartis shall inform Endo of such costs and, upon Endo's consent thereof, shall provide such data or information at Endo's expense. Notwithstanding the foregoing, if an investigation which is the subject of the preceding sentence reveals that Novartis was at fault in the matter under investigation, then Endo shall not be required to pay the resulting expenses. Novartis shall retain all records of the processing and manufacture of the Product in accordance with all applicable regulatory requirements. 10.1.2 Novartis shall notify Endo promptly of any inspections by federal, state, local or foreign regulatory authorities (including, without limitation, FDA, EPA, EEOC, OSHA and DEA or similar state agencies and building code inspectors) and of any communications from the FDA or any other regulatory authority to the extent such inspections concern, relate to or may impact the manufacture of the Products. To the extent reasonably feasible, Novartis shall obtain input from Endo prior to any response to the FDA or any other regulatory authority regarding the Facility as it pertains to Novartis' ability to perform its obligations hereunder. Endo shall have the right to observe any inspection of the Facility by the FDA or any other regulatory authority to the extent such inspections concern, relate to or may impact the manufacture of the Products; provided that this provision shall not require Novartis to postpone, delay or refuse entry to any such inspection in order to allow Endo's observation thereof. Novartis shall promptly provide Endo with a copy of any report issued or, if no report is issued, a written summary of the results of any such inspection. In addition, Novartis shall promptly provide Endo with a written summary of the actions, if any, required to remedy conditions cited in any such report. 10.1.3 Novartis shall notify Endo of any material discrepancy, violation or act of noncompliance with regards to compliance with any local, state o...
Novartis Obligations. (a) Ideaya acknowledges that the Ongoing Clinical Trial of LXS196 is being conducted by Novartis as of the Effective Date, and that such clinical trial will continue to be conducted by Novartis following the Effective Date. No Investigational New Drug Applications (“IND”) or Clinical Trial Applications (“CTA”) (i.e., sponsorship of the Regulatory Filings themselves) for the Ongoing Clinical Trials will be transferred to Ideaya. Copies of all Regulatory Filings (including INDs and CTAs) relating to LXS196 and/or Products incorporating LXS196 and all associated documents, correspondence, communications, etc. with respect to such Regulatory Filings in Novartis’ Control are included in the list of documents set forth in Exhibit E-2 in electronic form (where available, and otherwise in hard copy form) and will be transferred to Ideaya as provided in Section 4. Subject to the limitation in Section 2.4, Ideaya will have the right to use the data and information in such Regulatory Filings for all lawful purposes. Novartis shall, and hereby does, grant to Ideaya a right of reference to and use of the Regulatory Filings in the United States in connection with seeking and maintaining Regulatory Approval relating to the Compound and/or Products, will provide letter of authorization with respect to Regulatory Filings relating to the Compound and/or Products outside the United States, and will provide all required documentation and support to enable Ideaya to exercise the foregoing rights. (b) On every [***] anniversary of the Effective Date until the completion of the Ongoing Clinical Trial, Novartis will provide a clinical update report including the number of patients ongoing per arm and number of ongoing patients per country.
Novartis Obligations. Novartis shall use all reasonable endeavours to ensure that all data, information and material provided to the Vendor is sufficient and accurate for the Vendor’s performance of this Agreement. In case the Vendor needs any additional data, information and/or material to perform this Agreement, the Vendor shall give reasonably and sufficiently clear instructions to Novartis within a reasonable timeframe in advance and in any event shall not delay any of the Vendor’s performance obligations.
Novartis Obligations. Novartis will: 6.1 make available appropriate personnel to liaise with the Supplier; 6.2 provide the Supplier with all reasonable access to Novartis' premises and to any agreed Novartis resources necessary for the provision of the Services; 6.3 provide all information reasonably requested by the Supplier.
Novartis Obligations. 2.2.1 Novartis will cooperate with QLT in good faith to effect a smooth transition in accordance with the Transition Plan during the Pre-Transition Period. As soon as reasonably practicable after the Restatement Date, but in no case later than the Transition Effective Date, Novartis will transfer to QLT copies of all available sales records and customer lists for the Visudyne Product in the QLT Territory acquired or maintained by Novartis, including identification of customers and/or quantities of Visudyne Product sold to such customers. Upon and after the Transition Effective Date, Novartis shall, to the extent reasonably practicable and in a timely manner, comply with any reasonable written request from QLT for further information with regard to such sales records and customer lists.
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Novartis Obligations. (a) Novartis shall use commercially reasonable efforts to perform such activities designated as Novartis activities in each Development Plan within the time periods, specifically set forth therefor in such Development Plan. (b) Novartis shall supply Noven in a timely manner with all information in Novartis' possession that is reasonably required by Noven to perform its obligations hereunder with respect to any Development Product. (c) Novartis shall comply with all applicable federal, state and local laws, rules and regulations, including GLPs and GMPs, relating to Novartis' activities to be performed hereunder.

Related to Novartis Obligations

  • TRANSNET’S OBLIGATIONS 8.1 Transnet undertakes to promptly comply with any reasonable request by the Supplier/Service Provider for information, including information concerning Transnet's operations and activities, that relates to the Goods/Services as may be necessary for the Supplier/Service Provider to provide the Goods/Services, but for no other purpose. However, Transnet's compliance with any request for information is subject to any internal security rules and requirements and subject to the observance by the Supplier/Service Provider of its confidentiality obligations under this Agreement. 8.2 The Supplier/Service Provider shall give Transnet reasonable notice of any information it requires. 8.3 Transnet agrees to provide the Supplier/Service Provider or its Personnel such access to and use of its facilities as is necessary to allow the Supplier/Service Provider to perform its obligations under this Agreement.

  • Developer’s Obligations 7.1.1 In consideration of the Rights hereby granted, the Developer shall pay to the Authority an annual fee of Rs. /- (Rupees only) (“Fee”) commencing from the 1st (first) anniversary of Appointed Date. The Fee is exclusive of GST and all other applicable taxes and shall be payable by the Developer at actual over and above the Fee. The Fee is payable to the Authority on or before 30 (thirty) days prior to the start of every year in advance as set out in Schedule 1 throughout the Agreement Period. During the Agreement Period the Fee shall be increased by 5% (five percent) every year over the previous year’s Fee on compounded basis. 7.1.2 The Developer should pay the Fee to the Authority notwithstanding the fact that, the development of Project Facilities is not completed within the specified period or Developer does not start the commercial operation of the Project. In other words, the Developer shall not be entitled to seek any reduction of Fee, claim, damages, compensation or any other consideration from the Authority on account of any reason. 7.1.3 Any delay in payment of the Fee shall attract an interest for the delayed period at the rate of SBI PLR plus 5% per annum on the outstanding amount, which shall be due from the date of such payment till the amount is realized by the Authority. In addition to the foregoing, any delay in payment of Fee beyond a period of 60 (sixty) days from the due date of such payment will be construed to be Material Breach under this Agreement.

  • Licensors Obligations 4.5.1. Xxxxx the Licensee the right to use the intellectual property (the Service) as in the Agreement. Ensure 24/7 availability of the Service, apart from preventive maintenance time. 4.5.2. Keep confidential any information, materials, documents which become available to the Licensee in the course of performance of this Agreement. 4.5.3. Duly publish the official messages (documents) related to the right to use the Service.

  • Parties Obligations The Parties’ obligations under this Agreement will continue notwithstanding the existence of a Material Change.

  • Client’s Obligations 4.1 The Client shall: (a) ensure that the terms of the Order and any other information it provides in the Order Form are complete and accurate; (b) co-operate with the Company in all matters relating to the Services; (c) provide the Company, its employees, agents, consultants and subcontractors, with access to the Client’s premises, office accommodation and other facilities as reasonably required by the Company to provide the Services; (d) provide the Company with such information and materials as the Company may reasonably require in order to supply the Services, and ensure that such information is complete and accurate in all material respects; (e) prepare the Client’s premises for the supply of the Services; (f) obtain and maintain all necessary licences, permissions and consents which may be required for the Services before the date on which the Services are to start; (g) comply with all applicable laws, including health and safety laws; and (h) keep all materials, equipment, documents and other property of the Company (Company Materials) at the Client’s premises in safe custody at its own risk, maintain the Company Materials in good condition until returned to the Company, and not dispose of or use the Company Materials other than in accordance with the Company’s written instructions or authorisation; and (i) comply with any additional obligations as set out in the Order Form. 4.2 If the Company’s performance of any of its obligations under the Contract is prevented or delayed by any act or omission by the Client or failure by the Client to perform any relevant obligation (Client Default): (a) without limiting or affecting any other right or remedy available to it, the Company shall have the right to suspend performance of the Services until the Client remedies the Client Default, and to rely on the Client Default to relieve it from the performance of any of its obligations in each case to the extent the Client Default prevents or delays the Company’s performance of any of its obligations; (b) the Company shall not be liable for any costs or losses sustained or incurred by the Client arising directly or indirectly from the Company’s failure or delay to perform any of its obligations as set out in this Clause 4.2; and (c) the Client shall reimburse the Company on written demand for any costs or losses sustained or incurred by the Company arising directly or indirectly from the Client Default. 4.3 The Client shall provide any Client Requirements to the Company in a timely manner in order to enable the Company to provide the Services, including, without limitation, all materials, assets, information and/or documentation of the Client which the Client has agreed to provide or which subsequently becomes necessary to provide in order to allow the Company to provide the Services. 4.4 In the event that the Client should fail to supply the Client Requirements at the time specified or in a timely manner as set out in the above clause 4.3, the Company shall not be held responsible for any consequences of such delays, and the Clients hereby holds harmless the Company from and against all claims, liabilities, losses, costs or expenses arising out of or in connection with such delays.

  • Student’s Obligations The Student agrees:

  • Licensee’s Obligations 3.1 The Licensee shall pay the Licence Fee in advance on or before the 7th day of each English calendar month. 3.2 The Licensee shall observe, perform, conform and comply with and carry out at its own cost in so far as the Licensed Premises are concerned, terms and conditions thereof and provisions, requirements of such acts, rules, regulations, notifications and notices which may, from time to time, be or made applicable or may be issued and certified in respect of the Licensed Premises by Union of India, State of Maharashtra, Municipal Corporation of Greater Mumbai and/or any local or public authority (except such of the provisions and requirements thereof as may involve structural alteration in the Licensed Premises or any part thereof) and shall, at all times indemnify and keep always indemnified the Licensor from and against all liabilities, costs, charges and expenses in respect of non-observance, non-performance and non-compliance thereof. 3.3 The Licensee will keep the interior of the Licensed Premises and every part thereof including doors, windows, shutters, pipes, including existing false ceiling, air conditioning ducting etc., and all additions and improvements therein and thereto in good and substantial repair and condition, (subject to reasonable wear and tear) save and except any such items as have been removed with prior approval of the Licensor. 3.4 In the event, the Licensee as a corporate entity, undertakes any restructuring resulting in formation of subsidiaries of the Licensee, the Licensee may be permitted to extend the use and occupation of the Licensed Premises to such of its subsidiaries so far as the such subsidiaries are in the same line of business as the Licensee and that the permission by the Licensor to extend the use and occupation of the Licensed Premises is at the absolute discretion of the Licensor and with the Licensor's prior express written consent which consent shall not be unreasonably withheld. Provided however, the Licensee shall promptly notify the Licensor of the use of the Licensed Premises by such subsidiaries. 3.5 The Licensee shall use the Licensed Premises without in any manner disturbing and/or interfering with the activities and business of the Licensor or its associates or its subsidiary companies or any other persons authorised by the Licensor in that regard. 3.6 The Licensee shall take all steps reasonably deemed necessary for protecting the Licensed Premises 3.7 The Licensee shall take utmost care in using the Licensed Premises and shall use the Licensed Premises only for the business of the Licensee and in a lawful manner and for no other purpose. 3.8 The Licensee shall keep the Licensed Premises and every part thereof in clean and tidy condition. The Licensee shall not keep anything in or around the Licensed Premises, which shall always be kept un-littered and clean. 3.9 The Licensee or its representatives shall not in any manner prevent the Licensor or any other person authorised by the Licensor from using the common facilities and things used in common with the Licensor or any other person or occupiers authorised by the Licensor. 3.10 The Licensee shall not do any act, deed, thing and matter which would constitute a breach of any statutory requirements and which would adversely affect the Licensed Premises or any part thereof or the rights of the Licensor. 3.11 The Licensee shall at its own cost provide fire safety equipment on the Licensed Premises. In so far as the compliance with the provisions of the Maharashtra Fire Prevention and fire safety laws is concerned the Licensee shall at it own cost provide all the fire safety equipments and take all steps necessary to ensure compliance with the provisions of such laws as may be applicable in this regard. 3.12 The Licensee agrees, confirms and undertakes to bear/reimburse all costs, charges and expenses relating to stamping and registration of this Agreement and its duplicate in their entirety, and shall extend all cooperation to the Licensor in getting the said Agreement registered. However, each Party shall bear its own legal costs.

  • Obligations of the Licensee 5.1.1. The Licensee’s Responsibilities and Duties shall include the following, in addition to and without prejudice to other obligations under this Agreement: a. to obtain due permits, necessary approvals, clearances and sanctions from Maha-Metro and all other competent authorities for all activities or infrastructure facilities including interior decoration, power, water supply, drainage & sewerage, telecommunication, etc.; b. to comply and observe at all times with all Applicable Permits, approvals and Applicable Laws in the performance of its obligations under this Agreement including those being performed by any of its contractors; c. to develop, operate and maintain the Licensed Area at all times in conformity with this Agreement; d. to furnish Maha-Metro with the “As built” Drawings of the Licensed Space(s) within the Moratorium Period; e. to ensure that no structural damage is caused to the existing buildings and other permanent structures at the station as a result of his activities or any of its agents, contractors etc.; f. to take all reasonable steps to protect the environment (both on and off the property business space) and to limit damage and nuisance to people and property resulting from construction and operations, within guidelines specified as per Applicable Laws and Applicable Permits; g. to duly supervise, monitor and control the activities of contractors, agents, etc., if any, under their respective License Agreements as may be necessary; h. to take all responsible precautions for the prevention of accidents on or about the property business space and provide all reasonable assistance and emergency medical aid to accident victims; i. not to permit any person, claiming through or under the Licensee, to create or place any encumbrance or security interest over whole or any part of the Licensed premises and/or other installed assets, or on any rights of the Licensee therein or under this Agreement, save and except as expressly permitted in this Agreement; j. to keep the Licensed Space free from all unnecessary obstruction during execution of works and store the equipment or surplus materials, dispose of such equipment or surplus materials in a manner that causes least inconvenience to the Xxxxx Xxxxxxx, metro commuters or Maha-Metro’s activities. k. at all times, to afford access to the Licensed Property Business Space to the authorised representatives of Maha-Metro, other persons duly authorised by any Governmental Agency having jurisdiction over the business of Licensed Property Business Space, to inspect the Licensed Property Business Space and to investigate any matter within their authority and upon reasonable notice; and l. use non-combustable material in the allotted space for creation/erection/installation of any kind of furniture, fixtures and or partitions within the space. Use of combustable material within the property business space shall not be permitted under any circumstances. m. to comply with the divestment requirements and hand over the Licensed Property Business Space to Maha-Metro upon Termination of the Agreement; 5.1.2. The Licensee shall be solely and primarily responsible to Maha-Metro for observance of all the provisions of this License Agreement on behalf of its employees and representatives and agents and any person acting under or for and on behalf of the Licensee, contractor (s) appointed for the Licensed Space as fully as if they were the acts or defaults of the Licensee, its agents or employees.

  • Recipient's Obligations The Recipient warrants that the information given to the British Council in connection with the Project Proposal is true and acknowledges that the British Council awards the Grant on this basis. The Recipient shall apply the Grant solely and exclusively for the purposes of funding the Project. The Recipient agrees to reimburse the British Council in full if the Grant is not used for this purpose. The Recipient confirms that the Project and the award of the Grant to it shall not breach any applicable State subsidy control rules. The Recipient shall notify the British Council in writing of any amount of other funding including other public sector funding (if any) and/or guarantees secured by or offered to it for any purpose related to the Project as soon as it is approved. The Recipient shall deliver the Project with (i) reasonable skill and care and to the highest professional standards (ii) in compliance at all times with the terms of this Agreement (and, in particular, the Special Terms (Schedule 1) and the Project Proposal (Schedule 2)), the reasonable instructions of the British Council and all applicable regulations and legislation in force from time to time. The Recipient shall allocate sufficient resources to enable it to comply with its obligations under this Agreement. The Recipient shall comply with, and complete and return any forms or reports from time to time required by, the British Council Requirements and/or the Eligibility Criteria. The Recipient shall comply with the Funder Requirements (if any) and shall do nothing to put the British Council in breach of the Funder Requirements (if any). The Recipient shall not at any time do or say anything which damages or which could reasonably be expected to damage the interests or reputation of the British Council or the Funder (if any) or their respective officers, employees, agents or contractors. The Recipient shall keep full and proper accounts and records of income and expenditure with regard to the Project and the British Council shall be entitled to receive copies of all information reasonably required on request (including, without limitation, bank statements, receipts and vouchers for expenditure incurred) and to audit the administration by the Recipient of the Grant and the Project. Where the British Council and/or the Funder requires more information or considers that any report and/or other documentation is not acceptable, or where the British Council and/or the Funder believes that the performance of the activity undertaken is not in accordance with this Agreement, the British Council shall provide sufficient details to the Recipient to enable it to rectify the situation. The British Council reserves the right to suspend or terminate (as the case may be) the Project and the Agreement in the event that the Recipient is not able to rectify the situation to the satisfaction of the British Council (and/or the Funder). The Recipient undertakes to work with the British Council to monitor and evaluate progress made towards achieving the Project through regular communication, face to face meetings if required and progress reports and agrees to provide any relevant information related to the activities detailed in the Project Proposal as and when requested. The Recipient shall comply with all applicable legislation and codes of practice relating to child protection and the promotion of the welfare of children in force in England and Wales and any other territory in which the Project takes place or to which the Project relates. The Recipient shall use its reasonable endeavours to ensure that it does not become involved in any conflict of interests between the interests of the British Council and/or the Funder and the interests of the Recipient itself or any client of the Recipient. The Recipient shall notify the British Council in writing as soon as is practically possible of any potential conflict of interests and shall follow the British Council’s reasonable instructions to avoid, or bring to an end, any conflict of interests. In the event that a conflict of interests does arise, the British Council shall be entitled to terminate this Agreement on immediate written notice.

  • City’s Obligations A. Following the execution of this Agreement, the CITY shall begin efforts to implement the activities described in Article I of this Agreement. The failure by the CITY to develop and implement the activities described in Article I of this Agreement shall constitute a breach of this Agreement. The CITY understands and agrees that, in the event termination of this Agreement by CITY, or pursuant to Article V of this Agreement, the CITY shall reimburse the IDC the full amount of money paid by the IDC to the CITY. B. In accordance with Chapter 2264 of the Texas Government Code, the CITY agrees not to knowingly employ an undocumented worker. During the term of this Agreement, the CITY shall notify the IDC of any complaint brought against CITY alleging that it has employed undocumented workers. If the CITY, or any branch, division or department of the CITY is convicted of a violation under 8 U.S.C. Section 1324a (f), the total amount of economic development grants it has received, together with interest at the rate of five percent (5%), shall be repaid by the CITY to the IDC not later than the one hundred twentieth (120th) day after the date the IDC becomes aware of and notifies the CITY of the violation. The CITY shall not be liable for a violation of Chapter 2264 by a subsidiary, affiliate, or franchisee, or by any person with whom the CITY contracts. The CITY shall reimburse the IDC the required amount within thirty (30) days of the termination of this Agreement. The CITY further certifies that CITY is following Texas Government Code Chapter 2252 (foreign terrorist organizations prohibited), Texas Government Code Chapter 2270 (boycott-Israel), and Texas Government Code Chapter 2274, (boycotts-energy company; discrimination – firearms entity or trade association). C. The CITY shall keep and maintain complete and accurate records relating to its hiring and employment of persons, which is separate and identifiable from its other records, and shall make such records available for not less than three (3) years following termination of this Agreement. The IDC and its representatives shall be entitled to inspect said records during the term of this Agreement and for three (3) years thereafter, upon reasonable notice to the CITY. The CITY’s failure to comply with this provision will constitute a breach of the Agreement.

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