Assignment of IND Sample Clauses

Assignment of IND. As soon as practicable, but in any event within 30 days after the Effective Date, MannKind will transfer the IND to United Therapeutics. Following the Effective Date, MannKind shall not initiate any interaction with any Regulatory Authority regarding the Product, nor engage in any correspondence with any Regulatory Authority regarding the Product, in each case except at the direction of United Therapeutics. In the event that MannKind receives any communications from a Regulatory Authority with respect to the Product, MannKind will promptly notify United Therapeutics and collaborate with United Therapeutics in drafting such response as United Therapeutics may reasonably deem appropriate. For clarity, commencing on the Effective Date, United Therapeutics shall have ultimate decision-making authority with respect to any communications with any competent Governmental Authority, Regulatory Authority or other administrative body with respect to the Product, including without limitation, the FDA. MannKind shall promptly provide to United Therapeutics copies of all Regulatory Filings for the Product made by or on behalf of MannKind or its Affiliates, together with copies of any correspondence with Regulatory Authorities or other government agencies relating to such Regulatory Filings and/or Product. Without limiting the foregoing, MannKind will ensure that it has transferred to United Therapeutics all Information that MannKind was required by Applicable Laws to maintain as the holder of the IND or that is necessary or useful to prepare and defend any inquiries from Regulatory Authorities.
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Assignment of IND. Adolor agrees to transfer to Santen, and hereby does transfer to Santen, all rights, title and interest in and to that certain IND having IND number 55834 filed with the FDA on April 29, 1998, which IND is currently owned and held by Adolor. Adolor shall take such actions and execute such documents as may be reasonably necessary to effectuate the foregoing assignment. **=Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.
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Assignment of IND. BMS hereby assigns to Pharmacopeia all of BMS’ rights, title and interests in and to any INDs filed by BMS with any Regulatory Authority in the Territory for the BMS564929 Compound and BMS will provide to Pharmacopeia one copy of such IND filing(s), including without limitation the drug master file for such filing. In connection with such assignment, BMS shall deliver to Pharmacopeia within fifteen (15) business days of the Effective Date, one (1) electronic or paper copy of all correspondence, responses, meeting minutes and other documentation by and between BMS and any Regulatory Authority relating to such IND filing(s), and all documents relating to contacts by or on behalf of BMS and any Regulatory Authority and related to such IND filing(s) (the IND filing and such ancillary materials, the “IND Materials”). For the avoidance of doubt, upon such assignment, Pharmacopeia shall own all right, title and interest in and to the IND Materials. The Parties will work to provide any formal notice of the assignment of the INDs to Pharmacopeia pursuant to this Section 4.4 to the Regulatory Authorities to effect such assignment. Notwithstanding anything to the contrary in this Agreement, documents related to the BMS564929 Toxicology Studies will be provided by BMS as soon as possible, but in no event later than sixty (60) days after the Effective Date.
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Assignment of IND. Benuvia hereby transfers and assigns to Chromocell Benuvia’s entire right, title and interest in and to all INDs in Benuvia’s Control with respect to all Licensed Products. Within thirty (30) days of the Effective Date, Benuvia shall submit one or more letters to the FDA as required by the FDA to effect the foregoing assignment, substantially in the form of Exhibit A. and Chromocell shall promptly submit to the FDA the letter(s) and forms required by the FDA to complete the assignment of the IND. The Parties shall continue to cooperate with respect to the documentation required by the FDA to complete the assignment with time being of the essence.
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Related to Assignment of IND

  • Assignment of Agreement The following conditions must be satisfied in order to effectuate any assignment of this Agreement: (i) This Agreement may only be transferred through a book entry system maintained by Principal Life, or an agent designated by it, within the meaning of Temporary Treasury Regulations Section 5f.103-1(c) and Treasury Regulations Section 1.871-14(c)(1)(i). (ii) The Agreement Holder, and any assignee, must comply with applicable securities laws. (iii) Principal Life has consented in writing to the proposed assignment, such consent not to be unreasonably withheld. (iv) Principal Life shall have received from the proposed assignee a duly executed certificate containing, in substance, the information, representations, warranties, acknowledgments and agreements set forth in this Agreement. Any attempted sale, transfer, anticipation, assignment, hypothecation, or alienation not in accordance with this Section 6 shall be void and of no effect. Until such time, if any, as Principal Life has consented in writing to a proposed assignment, Principal Life shall not be obligated to make any payments to or at the direction of anyone other than the person shown on Principal Life’s books and records as the Agreement Holder. Once the foregoing conditions have been satisfied with respect to an assignment, the assignee or its successor shall be deemed to be the sole Agreement Holder for all purposes of this Agreement and Principal Life shall promptly amend its records to reflect the assignee’s status as Agreement Holder.

  • Assignment of Agreements Each applicable Borrower shall have executed and delivered to Lender the Assignments of Agreements, and the Assignments of Agreements shall, to the extent prudent pursuant to local practice, have been irrevocably delivered to an authorized title agent for the Title Insurer for such recordation in the appropriate filing offices in the jurisdiction in which the applicable Individual Property is located.

  • Assignment of Insurance As additional security for the payment and performance of the Obligations, the Borrower hereby assigns to the Lender any and all monies (including, without limitation, proceeds of insurance and refunds of unearned premiums) due or to become due under, and all other rights of the Borrower with respect to, any and all policies of insurance now or at any time hereafter covering the Collateral or any evidence thereof or any business records or valuable papers pertaining thereto, and the Borrower hereby directs the issuer of any such policy to pay all such monies directly to the Lender. At any time, whether or not a Default Period then exists, the Lender may (but need not), in the Lender's name or in the Borrower's name, execute and deliver proof of claim, receive all such monies, endorse checks and other instruments representing payment of such monies, and adjust, litigate, compromise or release any claim against the issuer of any such policy.

  • Assignment, Etc The Holder may assign or transfer this Note to any transferee at its sole discretion. This Note shall be binding upon the Company and its successors and shall inure to the benefit of the Holder and its successors and permitted assigns.

  • Assignment of Interest The lessee may not assign or sublet any interest held under this lease, including a security interest, without the prior written approval of the lessor. The lessor may approve such assignment or subletting if the lessor finds it to be in the best interest of the state. No such assignment or subletting will be effective until approved by the lessor in writing, and the assignee agrees to be subject to and governed by the provisions of this lease, any subsequent amendments to this lease, any additional stipulations, or reappraisal as deemed appropriate by the lessor, and all applicable laws, regulations, and ordinances in the same manner as the original lessee. No assignment or subletting of the leasehold, or any portion thereof, by the lessee will annul the lessee's obligation to pay the compensation required for the full term of this lease. Except as provided in this lease, no subdivision of the leasehold interest may occur without the prior written approval of the lessor.

  • Assignment of Inventions Subject to Sections 2.4, and 2.6, I hereby assign and agree to assign in the future (when any such Inventions or Proprietary Rights are first reduced to practice or first fixed in a tangible medium, as applicable) to the Company all my right, title and interest in and to any and all Inventions (and all Proprietary Rights with respect thereto) whether or not patentable or registrable under copyright or similar statutes, made or conceived or reduced to practice or learned by me, either alone or jointly with others, during the period of my employment with the Company. Inventions assigned to the Company, or to a third party as directed by the Company pursuant to this Section 2, are hereinafter referred to as “Company Inventions.”

  • Non-Assignment of Agreement The Grantee may not assign, sublicense or otherwise transfer its rights, duties or obligations under this Agreement without the prior written consent of the Division, which shall not unreasonably be withheld. The agreement transferee must demonstrate compliance with the requirements of the project. If the Division approves a transfer of the Grantee’s obligations, the Grantee shall remain liable for all work performed and all expenses incurred in connection with this Agreement. In the event the Legislature transfers the rights, duties and obligations of the Division to another governmental entity, pursuant to Section 20.06, Florida Statutes or otherwise, the rights, duties and obligations under this Agreement shall be transferred to the succeeding governmental agency as if it was the original party to this Agreement.

  • Assignment of Contract A. Unless expressly agreed to elsewhere in the Contract, no assignment by a party hereto of any rights under or interests in the Contract will be binding on another party hereto without the written consent of the party sought to be bound; and, specifically but without limitation, money that may become due and money that is due may not be assigned without such consent (except to the extent that the effect of this restriction may be limited by law), and unless specifically stated to the contrary in any written consent to an assignment, no assignment will release or discharge the assignor from any duty or responsibility under the Contract Documents.

  • Trademark Assignment Upon the request of Theravance, GSK shall prepare a global assignment to Theravance of any Trademark extensively and publicly used by GSK and Theravance in connection with the Terminated Respiratory Development Alliance Product. If Theravance elects to record the Assignment, Theravance shall undertake such recordal tasks and shall bear the costs and fees associated with the recordal, including but not limited to all filing fees, agent fees, and costs of notarization and legalizations. GSK shall cooperate with Theravance as reasonably necessary. Notwithstanding the foregoing, in the event that any Trademark is used by GSK on any other product, GSK shall not assign such Trademark as contemplated in the preceding sentence but shall license such Trademark to Theravance on a non-exclusive basis and subject to any further license terms to be agreed by the Parties in good faith at the time.

  • Assignment of Contracts GSAM agrees to assign (or cause to be assigned) to GSRP or OpCo without recourse, representation or warranty (except as expressly set forth in this Agreement), all of GSAM’s or such Affiliate’s right, title and interest in and to, and GSRP agrees to assume, or cause OpCo to agree to assume, the obligations of GSAM or such Affiliate’s obligations under, each of the Contracts set forth on Section 6.18 of the GSRP Disclosure Letter (collectively the “Assigned Contracts”), pursuant to documentation (the “Assigned Contracts Documentation”) in form and substance consistent with this Section 6.18 and otherwise in form and substance satisfactory to the Parties. GSAM has made available, or caused to be made available, to GSRP true and correct copies of the Assigned Contacts. Except as provided below, GSAM shall remain responsible for paying and satisfying, and shall protect, defend, indemnify and hold harmless GSRP from, all Liabilities related to or arising from the Assigned Contracts, to the extent such Liabilities relate to or arise from the period prior to the Closing. GSRP shall be responsible for paying and satisfying, and shall protect, defend, indemnify and hold harmless GSAM from, all Liabilities related to or arising from the Assigned Contracts, to the extent such Liabilities relate to or arise from the period on or after the Closing. Notwithstanding the second preceding sentence, in the case of any Assigned Contract that prior to the Closing was for the benefit of the GSRP Entities, from and after the Closing GSRP shall protect, defend, indemnify and hold harmless GSAM from, all Liabilities, related to or arising from such Assigned Contract, to the extent GSRP is required to do so under the Management Agreement. Without limiting the foregoing, OpCo shall remain responsible for, and shall pay and discharge when due all Liabilities that constitute Company Expenses (as defined in the OpCo LLC Agreement) that were incurred prior to the Closing.

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