Santarus Control Sample Clauses

Santarus Control. Santarus will have the final decision-making authority in every case, in its discretion, on whether and how to supplement, amend or otherwise alter the PR Product Registrations and any other issues in connection with such PR Product Registrations (including decisions, subject to Section 7.3, to recall the PR Product) and on whether and how to communicate with the FDA and other applicable Governmental Authorities in connection with such PR Product Registrations; provided, however, that Santarus will notify GSK in advance of making any planned changes to the PR Product Registration that would reasonably be anticipated to impact the characteristics or performance of the API or finished drug product with respect to PR Products for the Territory, or other material changes in the specifications or other particulars in the PR Product Registrations with respect to PR Products for the Territory. In the event that the Parties provide for an Authorized Manufacturer to manufacture PR Products for sale in the Territory by GSK (other than a Third Party manufacturer that is then utilized by Santarus for manufacture of the applicable PR Product for the United States), Santarus will reasonably coordinate and cooperate with GSK and such Authorized Manufacturer, at GSK’s expense, to supplement, amend or otherwise alter the PR Registration solely to the extent reasonably necessary to obtain required authorization for such Authorized Manufacturer to manufacture the PR Product in accordance with the Specifications, procedures and other requirements set forth in the PR Product Registration for PR Product sold by Santarus in the United States; provided, however, that Santarus shall not be obligated to accept or agree to any change in the Specifications, manufacturing process or QA or QC procedures, or to agree to any modification of the PR Product Registration that could, in Santarus’ reasonable opinion, have an adverse effect on the manufacture, use or sale of PR Product in the United States by or under authority of Santarus.
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Related to Santarus Control

  • Quality Control A. Controlled Affiliate agrees to use the Licensed Marks and Name only in connection with the licensed services and further agrees to be bound by the conditions regarding quality control shown in attached Exhibit A as they may be amended by BCBSA from time-to-time.

  • Access Control Landlord shall be the sole determinant of the type and amount of any access control or courtesy guard services to be provided to the Project, if any. IN ALL EVENTS, LANDLORD SHALL NOT BE LIABLE TO TENANT, AND TENANT HEREBY WAIVES ANY CLAIM AGAINST LANDLORD, FOR (I) ANY UNAUTHORIZED OR CRIMINAL ENTRY OF THIRD PARTIES INTO THE PREMISES, THE BUILDING OR THE PROJECT, (II) ANY DAMAGE TO PERSONS, OR (III) ANY LOSS OF PROPERTY IN AND ABOUT THE PREMISES, THE BUILDING OR THE PROJECT, BY OR FROM ANY UNAUTHORIZED OR CRIMINAL ACTS OF THIRD PARTIES, REGARDLESS OF ANY ACTION, INACTION, FAILURE, BREAKDOWN, MALFUNCTION AND/OR INSUFFICIENCY OF THE ACCESS CONTROL OR COURTESY GUARD SERVICES PROVIDED BY LANDLORD, IF ANY. Tenant shall provide such supplemental security services and shall install within the Premises such supplemental security equipment, systems and procedures as may reasonably be required for the protection of its employees and invitees, provided that Tenant shall coordinate such services and equipment with any security provided by Landlord. The determination of the extent to which such supplemental security equipment, systems and procedures are reasonably required shall be made in the sole judgment, and shall be the sole responsibility, of Tenant. Tenant acknowledges that it has neither received nor relied upon any representation or warranty made by or on behalf of Landlord with respect to the safety or security of the Premises or the Project or any part thereof or the extent or effectiveness of any security measures or procedures now or hereafter provided by Landlord, and further acknowledges that Tenant has made its own independent determinations with respect to all such matters.

  • Manufacturing Technology Transfer With respect to each Technology Transfer Product, upon AbbVie’s written request after the Inclusion Date for the Included Target to which such Technology Transfer Product is Directed, Morphic shall effect a full transfer to AbbVie or its designee (which designee may be an Affiliate or a Third Party manufacturer) of all Morphic Know-How and Joint Know-How relating to the then-current process for the Manufacture of such Technology Transfer Product (the “Manufacturing Process”) and to implement the Manufacturing Process at facilities designated by AbbVie (such transfer and implementation, as more fully described in this Section 5.3, the “Manufacturing Technology Transfer”). To assist with the Manufacturing Technology Transfer, Morphic will make its personnel reasonably available to AbbVie during normal business hours for up to [***] FTE hours with respect to each Included Target (in each case, free of charge to AbbVie) to transfer and implement the Manufacturing Process under this Section 5.3. Thereafter, if requested by AbbVie, Morphic shall continue to perform such obligations; provided, that AbbVie will reimburse Morphic for its full-time equivalent (FTE) costs (for clarity, in excess of [***] FTE hours) and any reasonable and verifiable out-of-pocket costs incurred in providing such assistance. CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED.

  • Manufacturing and Marketing Rights The Company has not granted rights to manufacture, produce, assemble, license, market, or sell its products to any other person and is not bound by any agreement that affects the Company's exclusive right to develop, manufacture, assemble, distribute, market, or sell its products.

  • Control Notwithstanding any other provision of the Agreement, it is understood and agreed that the Trust shall at all times retain the ultimate responsibility for and control of all functions performed pursuant to this Agreement and has reserved the right to reasonably direct any action hereunder taken on its behalf by the Sub-Adviser.

  • Manufacturing License Subject to the terms of this Agreement, including without limitation Section 2.2, Theravance grants to GSK an exclusive license under the Theravance Patents and Theravance Know-How to make and have made API Compound or formulated Alliance Product in the Territory.

  • Pest Control Landlord will be responsible for termite and rodent control. Landlord shall not provide pest control services (which include the removal of ants, cockroaches, spiders and other insects). If the Tenant has a xxxxx infestation after they move in they will be considered the cause of it and charged for the treatments. A pest control company will be sent to the property after the first 6 months of the lease, if an issue is found the tenants will be charged for the treatments.

  • Clinical Development (a) Stellartech shall design, develop and construct a Clinical Unit for each of the Thermage Disposable Device and the Thermage Generator, and any required component or subassembly thereof and shall deliver such Clinical Units to Thermage in accordance with the Development Program; (b) Stellartech shall deliver to Thermage such other Deliverables as are contemplated by the Development Program in accordance with the Development Program; and (c) as requested by Thermage and automatically at the conclusion of the Development Program, Stellartech, so long as Thermage is not in breach of its material obligation hereunder, shall deliver in writing to Thermage any and all data and information held by or in the control of Stellartech which is necessary or useful to obtain regulatory approval of the Products in the United States or any foreign country.

  • Commercialization License Subject to the terms of this Agreement, including without limitation Section 2.2 and Theravance's Co-Promotion rights in Section 5.3.2, Theravance hereby grants to GSK, and GSK accepts, an exclusive license under the Theravance Patents and Theravance Know-How to make, have made, use, sell, offer for sale and import Alliance Products in the Territory.

  • Litigation Control The Master Servicer, with respect to litigation involving non-Specially Serviced Mortgage Loans (other than any Non-Serviced Mortgage Loan), and the Special Servicer, with respect to litigation involving Specially Serviced Mortgage Loans and the enforcement of the obligations of a Mortgagor under the related Specially Serviced Mortgage Loan documents, and in each case where the Master Servicer or the Special Servicer, as applicable, contemplates availing itself of indemnification as provided for under this Agreement, shall, for the benefit of the Certificateholders, direct, manage, prosecute, defend and/or settle any and all claims and litigation relating to any action brought by the Mortgagor against the Trust or the Master Servicer or the Special Servicer, as applicable, with respect to any such Mortgage Loan (the foregoing rights and obligations, “Litigation Control”). Such Litigation Control shall be carried out in accordance with the terms of this Agreement, including, without limitation, the Servicing Standard. Upon becoming aware of or being named in any claims or litigation, the Master Servicer or Special Servicer, as applicable, shall promptly notify the Controlling Class Representative (during any Subordinate Control Period or any Collective Consultation Period) and the Special Servicer (in the case of the Master Servicer) and the Master Servicer (in the case of the Special Servicer) of such claims or litigation, and the Master Servicer and the Special Servicer, as applicable, shall prepare and submit a notice of such claims or litigation to the 17g-5 Information Provider (subject to Section 5.7) (and the 17g-5 Information Provider shall promptly post same on the 17g-5 Information Provider’s Website pursuant to Section 5.7). The Special Servicer (with respect to Specially Serviced Mortgage Loans) and the Master Servicer (with respect to non-Specially Serviced Mortgage Loans), as applicable, shall, during any Subordinate Control Period or any Collective Consultation Period, consult with and keep the Controlling Class Representative advised of any material development concerning Litigation Control, including, without limitation, (i) any material decision concerning Litigation Control and the implementation thereof and (ii) any decision to agree to or propose any terms of settlement, and shall, during any Subordinate Control Period, submit (in written form) any such development or decision to the Controlling Class Representative for its approval or consent. During any Subordinate Control Period and subject to the Servicing Standard, the Master Servicer or the Special Servicer, as applicable, shall not take any action implementing any such material development or decision described in the preceding sentence unless and until it has provided such notice to the Controlling Class Representative and the Controlling Class Representative has not objected in writing within five (5) Business Days of receipt of such notice and all information that the Controlling Class Representative has reasonably requested with respect thereto. The Controlling Class Representative shall be deemed to have approved the taking of such action if such written objection has not been received by the Master Servicer or the Special Servicer, as applicable, within such 5-Business Day period. Notwithstanding the foregoing, if the Master Servicer or the Special Servicer, as applicable, determines that immediate action is necessary to protect the interests of the Certificateholders (as a collective whole) and Master Servicer or the Special Servicer, as applicable, has confirmed (during any Subordinate Control Period) that the Controlling Class Representative has received written notice of such action, then the Master Servicer or the Special Servicer, as applicable, may take such action without waiting for the Controlling Class Representative’s response. Notwithstanding anything contained herein to the contrary, with respect to any Litigation Control relating to a non-Specially Serviced Mortgage Loan that has either (i) been satisfied or paid in full, or (ii) as to which a Final Recovery Determination has been made, after receiving the required notice from the Master Servicer or Special Servicer set forth above that the Master Servicer or Special Servicer, as applicable, became aware of or was named in any such claims or litigation, the Controlling Class Representative (during any Subordinate Control Period) or the Special Servicer (during any Collective Consultation Period or Senior Consultation Period) may direct in writing that such Litigation Control be exercised by the Special Servicer; provided, that the Controlling Class Representative or the Special Servicer in accordance with the Servicing Standard, as applicable, has determined and advised the Master Servicer that the Master Servicer’s actions with respect to such obligations are indemnifiable under this Agreement, and accordingly, any loss, liability or expense (including legal fees and expenses incurred up until the date such Litigation Control is so transferred and is not otherwise paid to the Master Servicer pursuant to this Agreement) shall be payable by the Trust. Notwithstanding the foregoing, no advice, direction or objection of, or consent withheld by, the Controlling Class Representative shall (i) require or cause the Special Servicer or the Master Servicer, as applicable, to violate the terms of any Mortgage Loan document, any Intercreditor Agreement or similar agreement, applicable law or any provision of this Agreement, including the Master Servicer’s and Special Servicer’s obligation to act in accordance with the Servicing Standard and the related Mortgage Loan documents and to maintain the REMIC status of any REMIC created under this Agreement, or (ii) result in an Adverse REMIC Event with respect to any REMIC created under this Agreement or an Adverse Grantor Trust Event with respect to the Grantor Trust or have adverse tax consequences for the Trust Fund, or (iii) expose any party to this Agreement, any Seller, any Underwriter or Initial Purchaser, any Sub-Servicer or the Trust Fund or any of their respective Affiliates, officers, directors, partners, members, managers, employees or agents to any claim, suit, or liability for which this Agreement does not provide indemnification to such party or expose any such party to prosecution for a criminal offense, or (iv) materially expand the scope of the Master Servicer’s, the Special Servicer’s, the Certificate Administrator’s, the Trustee’s or the Trust Advisor’s responsibilities under this Agreement. In addition, neither the Master Servicer nor the Special Servicer will follow any such advice, direction or objection if given by the Controlling Class Representative, or initiate any such actions, that would have the effect described in clauses (i)-(iv) of the preceding sentence. Notwithstanding anything herein to the contrary, the Master Servicer shall retain the right to make all determinations relating to any claims or judgments against the Master Servicer, including but not limited to the right to engage separate counsel in the Master Servicer’s reasonable discretion, the cost of which shall be subject to indemnification hereunder. Notwithstanding anything herein to the contrary, (i) if any action, suit, litigation or proceeding names the Certificate Administrator, the Trustee or the Custodian, as applicable, in its individual capacity, or if any judgment is rendered against the Certificate Administrator, the Trustee or the Custodian, as applicable, in its individual capacity, the Certificate Administrator, the Trustee or the Custodian, as applicable, upon prior written notice to the Master Servicer or the Special Servicer, as applicable, may retain counsel and appear in any such proceeding on its own behalf in order to protect and represent its interests (but not to otherwise direct, manage or prosecute such litigation or claim); (ii) in any action, suit, litigation or proceeding, other than an action, suit, litigation or proceeding directly relating to the enforcement of the obligations of a Mortgagor, guarantor or other obligor under the related Mortgage Loan documents, or otherwise directly relating to one or more Mortgage Loans or Mortgaged Properties, neither of the Master Servicer nor the Special Servicer shall, without the prior written consent of the Certificate Administrator, the Trustee or the Custodian, as applicable, (A) initiate any action, suit, litigation or proceeding in the name of the Certificate Administrator, the Trustee or the Custodian, as applicable, whether in such capacity or individually, (B) engage counsel to represent the Certificate Administrator, the Trustee or the Custodian, as applicable, or (C) prepare, execute or deliver any government filings, forms, permits, registrations or other documents or take any other similar action with the intent to cause, and that actually causes, the Certificate Administrator, the Trustee or the Custodian, as applicable, to be registered to do business in any state (provided that neither the Master Servicer nor the Special Servicer shall be responsible for 342 any delay due to the unwillingness of the Certificate Administrator, the Trustee or the Custodian, as applicable, to grant such consent); and (iii) if any court finds that the Certificate Administrator, the Trustee or the Custodian, as applicable, is a necessary party in respect of any action, suit, litigation or proceeding relating to or arising from this Agreement or any Mortgage Loan, the Certificate Administrator, the Trustee or the Custodian, as applicable, shall have the right to retain counsel and appear in any such proceeding on its own behalf in order to protect and represent its interest, whether as Certificate Administrator, the Trustee or the Custodian, as applicable, or individually (but not to otherwise direct, manage or prosecute such litigation or claim). Nothing in this paragraph shall be interpreted to preclude either the Master Servicer or the Special Servicer from initiating any Litigation Control related action, suit, litigation or proceeding in its name as a representative of the Trust Fund.

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