Deficient Sublicensees or Sites and Replacement Sample Clauses

Deficient Sublicensees or Sites and Replacement. To the extent permitted by Applicable Law, with respect to any Global Clinical Trial or Territory-Specific Clinical Trial, if any audit of a Clinical Trial site conducted pursuant to Section 5.8.1 (Conduct of Audits) identifies any non-compliance with GLP, GCP, or cGMP, as applicable, resulting in any deficiencies with respect to such Clinical Trial site (each, a “Deficient Site”) that may reasonably cause a Regulatory Authority to reject or otherwise deem deficient the Clinical Trial data from Partner’s conduct of any such Global Clinical Trial or Territory-Specific Clinical Trial (as applicable) at such Deficient Site, then subject to Partner’s right to remediate under Section 5.8.1 (Conduct of Audits), if Partner is unable to successfully remediate the situation and reasonably eliminate the condition causing the Clinical Trial site to be a Deficient Site, then Partner will promptly remove such Deficient Site from the applicable Global Clinical Trial or Territory-Specific Clinical Trial and replace such Deficient Site with a new Clinical Trial site (a “Replacement Site”) within the Territory [***]. Any such Replacement Site will be compliant in all respects with Applicable Law and ImmunoGen’s Global Clinical Trial standards. In addition, if any audit of any Sublicensee conducted pursuant to Section 5.8.1 (Conduct of Audits) identifies that any Sublicensee (including any contract research organizations or other subcontractors engaged to perform activities under the Global Development Plan or Territory Development Plan) is not performing its activities in accordance with GLP, cGMP, or GCP, as applicable, or in compliance with Applicable Law or that any deficiencies identified as a result of any such audit related to any such Sublicensee’s performance may cause a Regulatory Authority to reject or otherwise deem deficient the Clinical Trial data from Partner’s conduct of any such Global Clinical Trial or Territory-Specific Clinical Trial (as applicable) (each, a “Deficient Sublicensee”), then Partner will, in its reasonable discretion, promptly (a) require such Deficient Sublicensee to mitigate its deficiencies in a timely manner or (b) remove such Deficient Sublicensee from performing further activities under the Global Development Plan or Territory Development Plan and replace such Deficient Sublicensee with a new Sublicensee engaged in accordance with Section 2.2 (Sublicensing and Subcontractors) to perform the applicable Development activities at Partner...
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Related to Deficient Sublicensees or Sites and Replacement

  • Solicitations for Subcontracts, Including Procurement of Materials and Equipment In all solicitations either by competitive bidding or negotiation made by the Local Government for work to be performed under a subcontract, including procurement of materials or leases of equipment, each potential subcontractor or supplier will be notified by the Local Government of the Local Government’s obligations under this Agreement and the Acts and Regulations relative to Nondiscrimination on the grounds of race, color, or national origin.

  • Selection of Subcontractors, Procurement of Materials and Leasing of Equipment The contractor shall not discriminate on the grounds of race, color, religion, sex, national origin, age or disability in the selection and retention of subcontractors, including procurement of materials and leases of equipment. The contractor shall take all necessary and reasonable steps to ensure nondiscrimination in the administration of this contract. a. The contractor shall notify all potential subcontractors and suppliers and lessors of their EEO obligations under this contract. b. The contractor will use good faith efforts to ensure subcontractor compliance with their EEO obligations.

  • Solicitations for Subcontracts, Including Procurements of Materials and Equipment In all solicitations either by competitive bidding or negotiation made by the Engineer for work to be performed under a subcontract, including procurements of materials or leases of equipment, each potential subcontractor or supplier shall be notified by the Engineer of the Engineer's obligations under this contract and the Regulations relative to nondiscrimination on the grounds of race, color, or national origin.

  • Sublicensees Licensee shall have the right (but not the obligation) to sublicense those rights granted to it under Section 2.1 only as set forth in, and subject to the terms and conditions of, Section 2.5 and this Section 2.3.2, to (a) any Person (other than a Specified Person) with the prior written consent of Lxxxx, which consent will not be unreasonably withheld, conditioned or delayed; provided that Licensee may contract in the ordinary course of business with any Third Party contract research organization (“CRO”) or contract development and manufacturing organization (“CMO”) to handle certain clinical Development or Manufacturing activities, in Licensee’s reasonable discretion, without requiring Lilly’s consent; provided further that such CRO or CMO are working on Licensee’s behalf, (b) any of its Affiliates (only for so long as they remain Affiliates), provided that Licensee provides prior written notice (at least 20 Business Days in advance) to Lilly of any sublicenses to be granted to any Affiliate or its request for approval of any sublicense to be granted to any other Person, which shall include in each case a description of the rights to be granted and the purpose therefor, the identity of the proposed Sublicensee and the countries involved, or (c) a Specified Person. Each Affiliate or other Person to which any such sublicense is granted is referred to herein as a “Sublicensee.” Licensee shall remain responsible for the performance by each of its Sublicensees and shall cause each of its Sublicensees to comply with the applicable provisions of this Agreement, and Licensee shall be liable for the acts or omissions of its Sublicensees under or in connection with this Agreement (as if such acts or omission were those of Licensee). Without limiting the foregoing, Licensee shall: (x) ensure that each of its Sublicensees accepts in writing all applicable terms and conditions of this Agreement, including the non-compete, reporting, audit, inspection and confidentiality provisions hereunder; (y) under the agreements between Licensee and each of its Sublicensees, include a provision pursuant to which either (a) Lilly is named as a third-party beneficiary or (b) a mechanism (for example, a power of attorney) is implemented for Lxxxx to enforce all applicable terms and conditions of this Agreement against the Sublicensee in a manner reasonably satisfactory to Lilly, provided that, in each case, Lxxxx shall not proceed against any Sublicensee unless Lxxxx has first provided Licensee with written notice of the Sublicensee’s breach and Licensee has not, within 90 days after receipt of such notice, caused the Sublicensee to cease the breaching activity or otherwise cure the breach, in each case, to the reasonable satisfaction of Lxxxx; and (z) terminate all relevant agreements with any such Sublicensee in the case of any breach of such terms and conditions by such Sublicensee. A Sublicensee shall have the right to grant further sublicenses, subject to complying with the terms of this Section 2.3.2 with respect to further Sublicensees. For the avoidance of doubt, (i) Licensee will remain directly responsible for all amounts owed to Lilly under this Agreement, and (ii) each Sublicensee is subject to the negative and restrictive covenants set forth in Sections 2.2.1 and 2.4, respectively. Licensee hereby expressly waives any requirement that Lxxxx exhaust any right, power or remedy, or proceed against a subcontractor, for any obligation or performance hereunder prior to proceeding directly against Licensee. Notwithstanding anything to the contrary, (A) all sublicenses granted hereunder shall automatically terminate upon expiration or termination of this Agreement for any reason and (B) if the Parties enter into an agreement pursuant to Section 2.5 with respect to the Product, then as of the effective date of such agreement all sublicenses granted with respect to the Product shall automatically terminate, except as otherwise mutually agreed by the Parties in writing (and in no event shall any negotiations for any such agreement pursuant to Section 2.5 be conditioned on or otherwise affected by whether Lxxxx agrees to allow any such sublicenses to continue).

  • Public Improvements To the best knowledge of the Transferor Partnership, there are no written or proposed plans to widen, modify, or realign any street or highway or any existing or proposed eminent domain proceedings which would affect the Property in any way whatsoever. To the best knowledge of the Transferor Partnership, there are no presently planned public improvements which would result in the creation of a special improvement or similar lien upon the Property.

  • Third Party Materials The Application may display, include, or make available third-party content (including data, information, applications, and other products, services, and/or materials) or provide links to third-party websites or services, including through third- party advertising ("Third-Party Materials"). You acknowledge and agree that Company is not responsible for Third-Party Materials, including their accuracy, completeness, timeliness, validity, copyright compliance, legality, decency, quality, or any other aspect thereof. Company does not assume and will not have any liability or responsibility to you or any other person or entity for any Third-Party Materials. Third-Party Materials and links thereto are provided solely as a convenience to you, and you access and use them entirely at your own risk and subject to such third parties' terms and conditions.

  • Licensee “Licensee” means the individual or company that has entered into an Agreement with the Embassy. “Offer” means a response to a solicitation that, if accepted, would bind the offeror to perform the resultant Agreement.

  • Sublicense Requirements Any Sublicense: (A) is subject to this Agreement; (B) will reflect that any sublicensee will not further sublicense; (C) will prohibit sublicensee from paying royalties to an escrow or other similar account; (D) will expressly include the provisions of Sections 8, 9, and 10 for the benefit of Stanford; and (E) will include the provisions of Section 4.4 and require the transfer of all the sublicensee’s obligations to *****, including the payment of royalties specified in the Sublicense, to Stanford or its designee, if this Agreement is terminated. If the sublicensee is a spin-out from *****, ***** must guarantee the sublicensee’s performance with respect to the payment of Stanford’s share of Sublicense royalties.

  • Elements Unsatisfactory Needs Improvement Proficient Exemplary IV-A-1. Reflective Practice Demonstrates limited reflection on practice and/or use of insights gained to improve practice. May reflect on the effectiveness of lessons/ units and interactions with students but not with colleagues and/or rarely uses insights to improve practice. Regularly reflects on the effectiveness of lessons, units, and interactions with students, both individually and with colleagues, and uses insights gained to improve practice and student learning. Regularly reflects on the effectiveness of lessons, units, and interactions with students, both individually and with colleagues; and uses and shares with colleagues, insights gained to improve practice and student learning. Is able to model this element.

  • 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.

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