NDA and IND Transfers Sample Clauses

NDA and IND Transfers. KKUS will continue to hold the NDA for the Product until such time as the licensees, and associated territories, must no longer rely on the NDA. When this occurs, KKUS shall promptly transfer all of its right, title, and interest in and to the NDA to Cumberland (the “NDA Transfer Date”) as the final step in the sale and purchase of Assets pursuant to this Agreement. Prior to the NDA Transfer Date, KKUS shall license the NDA to Cumberland as forth in Section 2.4 below. KKUS will continue to hold the IND until such time as the FDA required Bioequivalence/Adhesion study and all associated interactions with FDA have been completed. When this occurs, KKUS shall promptly transfer all of its right, title, and interest in and to the IND to Cumberland (the “IND Transfer Date”). After the later of the IND Transfer Date and the NDA Transfer Date, the Assets shall include the NDA and all clinical and non-clinical data, and FDA files and registrations related to the Product in the Territory. KKUS shall be entitled to retain copies of the NDA, the IND, Product Records, Product Regulatory Materials and Marketing and Promotional Material in order to comply with its legal obligations.
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Related to NDA and IND Transfers

  • Promotions and Transfers Professional staff are eligible for a promotion which occurs when there is a vacancy at a higher level for which they are qualified. The announcement of the position vacancy will include a description of the position, a detailed outline of expected educational and professional requirements and the salary range for the position. Staff members may bid online on any open position for which they qualify provided those positions are not being reserved for staff members affected by a layoff or intradepartmental postings. All regular vacant negotiations unit positions will be posted on the University Hospital website. The announcement of the position vacancy will be posted daily online. Interested internal candidates are to apply online. Computer Kiosks for the purpose of accessing job vacancies will be available at each Human Resources Office. Beginning thirty (30) days after ratification of this agreement, each internal applicant within a department who applies during the first five (5) days of posting for a higher classification within the same department, as identified on the position posting, shall be interviewed. Each internal candidate will be notified in writing of the decision with respect to his or her candidacy on a timely basis. This decision will indicate: 1.) that the applicant has been offered the position, or 2.) that the applicant has not been offered the position, including a reason for such decision. The Hospital agrees that seniority and all other relevant criteria will be taken into consideration in the selection of internal applicants for a position. Any dispute regarding this paragraph shall be grievable to Step Two of the grievance procedure with the decision at Step Two being final and binding. Transfer in status or classification shall not delay the use of entitled benefits. At the time of promotion, a staff member shall be provided the opportunity to negotiate his/her salary increase and shall receive written notice of final salary offer. Acceptance of the position constitutes acceptance of the salary, and the amount of the promoted staff member’s salary shall not be subject to the grievance procedure. This provision shall not result in any promoted staff member being placed off guide. Voluntarily transferred and promoted staff members shall serve a ninety (90) calendar day probationary period, subject to a ninety (90) calendar day extension. Time spent on an authorized leave shall not count towards the probationary period. Reclassifications and Involuntary transfers within a Department do not serve a probationary period. Such staff member shall retain all benefits and rights pertaining to negotiations unit members, including access to the grievance procedure, except for the decision concerning the outcome and disposition of their probation period. At any time prior to the end of probation, the staff member may return to his/her former position, provided that it is still available. If an employee opts to return to his or her former position, the employee may not bid on another position for six months. Should the staff member fail probation, the Hospital shall return the staff member to his/her former position if it is still available. Should the staff member’s position not be available, the employee may be offered a vacant position to the classification of the former title held by the employee before the promotion, if one exists at University Hospital. If the vacant position is in a different department, the employee must serve a 90 calendar day probation period. If not, the employee will be placed on the recall list for one year.

  • Payments and Transfers 1. Except under the circumstances envisaged in Article 7.17 a Party shall not apply restrictions on international transfers and payments for current transactions relating to its specific commitments. 2. Nothing in this Chapter shall affect the rights and obligations of the Parties as members of the International Monetary Fund under the Articles of Agreement of the Fund, including the use of exchange actions which are in conformity with the Articles of Agreement, provided that a Party shall not impose restrictions on any capital transactions inconsistently with its specific commitments regarding such transactions, except under Article 7.17 or at the request of the Fund.

  • Void Transfers To the greatest extent permitted by the Act and other Law, any Transfer by any Member of any Membership Interests or other interest in the Company in contravention of this Agreement shall be void and ineffective and shall not bind or be recognized by the Company or any other Person. In the event of any Transfer in contravention of this Agreement, to the greatest extent permitted by the Act and other Law, the purported Transferee shall have no right to any profits, losses or Distributions of the Company or any other rights of a Member.

  • Asset Transfers The Company shall not (i) transfer, sell, convey or otherwise dispose of any of its material assets to any subsidiary except for a cash or cash equivalent consideration and for a proper business purpose or (ii) transfer, sell, convey or otherwise dispose of any of its material assets to any Affiliate, as defined below, during the Term of this Agreement. For purposes hereof, "Affiliate" shall mean any officer of the Company, director of the Company or owner of twenty percent (20%) or more of the Common Stock or other securities of the Company.

  • Permitted License Transfers As Licensee’s business operations may be altered, expanded or diminished, licenses granted hereunder may be transferred or combined for use at an alternative or consolidated site not originally specified in the license, including transfers between Agencies (“permitted license transfers”). Licensee(s) do not have to obtain the approval of Contractor for permitted license transfers, but must give thirty (30) days prior written notice to Contractor of such move(s) and certify in writing that the Product is not in use at the prior site. There shall be no additional license or other transfer fees due Contractor, provided that: i) the maximum capacity of the consolidated machine is equal to the combined individual license capacity of all licenses running at the consolidated or transferred site (e.g., named users, seats, or MIPS); or ii) if the maximum capacity of the consolidated machine is greater than the individual license capacity being transferred, a logical or physical partition or other means of restricting access will be maintained within the computer system so as to restrict use and access to the Product to that unit of licensed capacity solely dedicated to beneficial use for Licensee. In the event that the maximum capacity of the consolidated machine is greater than the combined individual license capacity of all licenses running at the consolidated or transferred site, and a logical or physical partition or other means of restricting use is not available, the fees due Contractor shall not exceed the fees otherwise payable for a single license for the upgrade capacity.

  • Certain Transfers The sale of all or substantially all of Tenant's assets (other than bulk sales in the ordinary course of business) or, if Tenant is a corporation, an unincorporated association, or a partnership, the transfer, assignment or hypothecation of any stock or interest in such corporation, association, or partnership in the aggregate of twenty-five percent (25%) (except for publicly traded shares of stock constituting a transfer of twenty-five percent (25%) or more in the aggregate, so long as no change in the controlling interest of Tenant occurs as a result thereof) shall be deemed an assignment within the meaning and provisions of this Article. Notwithstanding the foregoing, Landlord's consent shall not be required for the assignment of this Lease as a result of a merger by Tenant with or into another entity, so long as (i) the net worth of the successor entity after such merger is at least equal to the greater of the net worth of Tenant as of the execution of this Lease by Landlord or the net worth of Tenant immediately prior to the date of such merger, evidence of which, satisfactory to Landlord, shall be presented to Landlord prior to such merger, (ii) Tenant shall provide to Landlord, prior to such merger, written notice of such merger and such assignment documentation and other information as Landlord may request in connection therewith, and (iii) all of the other terms and requirements of this Article shall apply with respect to such assignment.

  • Onward transfers The data importer shall only disclose the personal data to a third party on documented instructions from the data exporter. In addition, the data may only be disclosed to a third party located outside the European Union (in the same country as the data importer or in another third country, hereinafter ‘onward transfer’) if the third party is or agrees to be bound by these Clauses, under the appropriate Module, or if: (i) the onward transfer is to a country benefitting from an adequacy decision pursuant to Article 45 of Regulation (EU) 2016/679 that covers the onward transfer; (ii) the third party otherwise ensures appropriate safeguards pursuant to Articles 46 or 47 Regulation of (EU) 2016/679 with respect to the processing in question; (iii) the onward transfer is necessary for the establishment, exercise or defence of legal claims in the context of specific administrative, regulatory or judicial proceedings; or (iv) the onward transfer is necessary in order to protect the vital interests of the data subject or of another natural person. Any onward transfer is subject to compliance by the data importer with all the other safeguards under these Clauses, in particular purpose limitation.

  • Exempt Transfers 12.1 Subject to the requirements of applicable Laws, the restrictions under Section 8 and the right of first refusal and right of co-sale under Section 9 and Section 10 shall not apply to (a) any sale of Equity Securities of the Company to the public pursuant to a Qualified IPO; and (b) Transfer of any Equity Securities of the Company now or hereinafter held by the Principal or the Ordinary Shareholder to the Principal’s another wholly owned entity or to a trustee, executor, or other fiduciary for the benefit of the Principal or the Principal’s any wholly owned entity or his spouse and lineal descendants (whether natural or adopted), brother, sister, parent for bona fide estate planning purposes (each such transferee pursuant to subsection (b) above, a “Permitted Transferee”, and collectively, the “Permitted Transferees”); provided, that (i) such Transfer is effected in compliance with all applicable Laws, including without limitation, the SAFE Regulations, (ii) the Principal shall remain liable for any breach by such Permitted Transferee of any provision hereunder; (iii) if any Permitted Transferee which received Equity Securities of the Company pursuant to this Section 12.1(b) ceases to be a Permitted Transferee for any reason, it shall immediately Transfer back to the applicable transferor from which it received the Equity Securities of the Company transferred to it pursuant to this Section 12.1(b) and (iv) adequate documentation therefor is provided to the Company and each such Permitted Transferee shall execute a joinder agreement in substantially the form attached hereto as Exhibit A assuming the obligations of such Ordinary Transferor under this Agreement and be bound by the terms of the Amended M&AA as the “Ordinary Shareholder” (if not already a Party hereto) upon and after such Transfer, with respect to the transferred Equity Securities; and (c) any Transfer of the Equity Securities of the Company by an Investor to any of its Affiliate; provided that (x) the transferees of such Transfer shall not be a Competitor or an Affiliate of any Competitor (provided that (A) GS shall be permitted to Transfer all or any of the Equity Securities of the Company held by it to any of the GS Controlled Affiliates, (B) Carlyle shall be permitted to Transfer all or any of the Equity Securities of the Company held by it to any of the Carlyle Controlled Affiliates and (C) Cathay shall be permitted to Transfer all or any of the Equity Securities of the Company held by it to any of the Cathay Controlled Affiliates); (y) if any transferee of such Transfer which received Equity Securities of the Company pursuant to this Section 12.1(c) ceases to be an Affiliate of such Investor for any reason or becomes a Competitor or an Affiliate of any Competitor (or in the case where the transferee is a GS Controlled Affiliate or a Carlyle Controlled Affiliate or a Cathay Controlled Affiliate, if it ceases to be a GS Controlled Affiliate or a Carlyle Controlled Affiliate or a Cathay Controlled Affiliate, as applicable, for any reason), it shall immediately Transfer back to the applicable transferor from which it received the Equity Securities of the Company transferred to it pursuant to this Section 12.1(c) and (z) the transferees of such Transfer shall execute and deliver a joinder agreement in substantially the form attached hereto as Exhibit A to join in and be bound by the terms of this Agreement and be bound by the terms of the Amended M&AA as the “Investor” (if not already a Party hereto) upon and after such Transfer. 12.2 All transfer restrictions provided in this Agreement with respect to a Transfer of Equity Securities of the Company by the Investors (including Section 8.2) shall cease to apply in the event that the Company fails to pay the applicable redemption price pursuant to Article 8.4 of the Amended M&AA and which is not cured after 30 days’ written notice of such breach delivered by an Investor to the Company. 12.3 Sections 8 through 11 shall not apply to any Transfer of any Equity Securities pursuant to any enforcement of security under any Facility Document or to any creation of security under any Facility Document; provided, however, that any transferee of such Equity Securities shall execute and deliver a joinder agreement in substantially the form attached hereto as Exhibit A to join in and be bound by the terms of this Agreement and be bound by the terms of the Amended M&AA as the “Ordinary Shareholder” (if not already a Party hereto) upon and after such Transfer. Notwithstanding anything to the contrary herein, this Section 12.3 may be further amended in respect of Sections 8 through 11 in connection with the negotiation of any Facility Document with the written consent of Majority Series A-1 Preferred Holders and the Company and the Parties shall procure any required alteration to the Amended M&AA to give effect to any such amendment.

  • TRANSFERS, SPLIT-UPS, AND COMBINATIONS OF RECEIPTS The transfer of this Receipt is registrable on the books of the Depositary at its Corporate Trust Office by the Owner hereof in person or by a duly authorized attorney, upon surrender of this Receipt properly endorsed for transfer or accompanied by proper instruments of transfer and funds sufficient to pay any applicable transfer taxes and the expenses of the Depositary and upon compliance with such regulations, if any, as the Depositary may establish for such purpose. This Receipt may be split into other such Receipts, or may be combined with other such Receipts into one Receipt, evidencing the same aggregate number of American Depositary Shares as the Receipt or Receipts surrendered. As a condition precedent to the execution and delivery, registration of transfer, split-up, combination, or surrender of any Receipt or withdrawal of any Deposited Securities, the Depositary, the Custodian, or Registrar may require payment from the depositor of Shares or the presenter of the Receipt of a sum sufficient to reimburse it for any tax or other governmental charge and any stock transfer or registration fee with respect thereto (including any such tax or charge and fee with respect to Shares being deposited or withdrawn) and payment of any applicable fees as provided in this Receipt, may require the production of proof satisfactory to it as to the identity and genuineness of any signature and may also require compliance with any regulations the Depositary may establish consistent with the provisions of the Deposit Agreement or this Receipt. The delivery of Receipts against deposits of Shares generally or against deposits of particular Shares may be suspended, or the transfer of Receipts in particular instances may be refused, or the registration of transfer of outstanding Receipts generally may be suspended, during any period when the transfer books of the Depositary are closed, or if any such action is deemed necessary or advisable by the Depositary or the Company at any time or from time to time because of any requirement of law or of any government or governmental body or commission, or under any provision of the Deposit Agreement or this Receipt, or for any other reason, subject to Article (22) hereof. Without limitation of the foregoing, the Depositary shall not knowingly accept for deposit under the Deposit Agreement any Shares required to be registered under the provisions of the Securities Act, unless a registration statement is in effect as to such Shares.

  • Rollover Contributions and Transfers The Custodian shall have the right to receive rollover contributions and to receive direct transfers from other custodians or trustees. All contributions must be made in cash or check.

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