Registration Batches Sample Clauses

Registration Batches. Upon Cempra’s request, FFFC shall prepare registration Batches of API as needed for Cempra (or its Affiliate or its or its Affiliates’ licensee) to seek Regulatory Approval in the Territory, in accordance with a plan therefor (and related payment provisions) to be reasonably negotiated in good faith and agreed upon in writing by the Parties (which plan, upon such agreement in writing by the Parties, will be set forth in Exhibit G), and coordinate with Cempra on any request from any Regulatory Authority. Upon successful delivery of the registration Batches in accordance with such plan (i.e., such Batches meet the API Specifications and are manufactured in a way that they meet the criteria for registration Batches), Cempra shall pay FFFC for the delivery of such Batches in accordance with the payment provisions to be set forth in Exhibit G. FFFC shall work in good faith to establish, in consultation and cooperation with Cempra, and subject to Cempra’s written agreement, reasonably appropriate success criteria for the registration Batches for API. If a particular registration Batch supplied by FFFC pursuant to this Section fails to meet such criteria, appropriate representatives from each Party shall meet and discuss and seek to determine the causes of such Batch having failed to meet such criteria and shall cooperate diligently to try to find a solution to such causes, and FFFC shall use best efforts to rectify any such problems as soon as practicable. FFFC will replace any such failed Batches at its cost (including paying for needed Raw Materials and the internal costs of conducting the manufacturing and supply). FFFC shall recommence manufacture and supply of the required registration Batches for API as soon as possible, and shall continue until such time as FFFC has successfully delivered to Cempra the number of consecutive Batches of API that meet the criteria that shall be set forth in Exhibit G, once agreed upon by the Parties as set forth above. Each such registration Batch supplied by FFFC shall meet the API Specifications and shall be suitable for use to support registration stability studies.
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Registration Batches. ETHYPHARM shall manufacture, deliver and sell to RELIANT such quantities of full commercial scale batches of the Product, in such formulations and dosage forms as requested by RELIANT, determined by RELIANT to be necessary to satisfy requirements under Applicable Law or Applicable Permit (including, without limitation, in connection with the filing and approval of an NDA with the FDA) to market the Product in the United States. All Product, in whatever formulation, for use by RELIANT to satisfy such requirements shall be: (a) sold to RELIANT at ETHYPHARM’s actual cost as determined in accordance with Exhibit D attached hereto; and (b) delivered by ETHYPHARM within thirty (30) days of ETHYPHARM’s receipt of RELIANT’s order therefor.
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Registration Batches. ETHYPHARM shall manufacture, deliver and sell to RELIANT such quantities of full commercial scale batches of the Product, in such formulations and dosage forms as requested by RELIANT, determined by RELIANT to be necessary to satisfy requirements under Applicable Law or Applicable Permit (including, without limitation, in connection with the filing and approval of an NDA with the FDA) to market the Product in the United States. All Product, in whatever formulation, for use by RELIANT to satisfy such requirements shall be: (a) sold to RELIANT at [***] as determined in accordance with Exhibit D attached hereto; and (b) delivered by ETHYPHARM within thirty (30) days of ETHYPHARM’s receipt of RELIANT’s order therefor.
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Registration Batches. ETHYPHARM shall manufacture, deliver and sell to RELIANT such quantities of full commercial scale batches of the Product, in such formulations and dosage forms as requested by RELIANT, determined by RELIANT to be necessary to satisfy requirements under Applicable Law or Applicable Permit (including, without limitation, in connection with the filing and approval of an NDA with the FDA) to market the Product in the United States. All Product, in whatever formulation, for use by RELIANT to satisfy such requirements shall be: (a) sold to RELIANT at ETHYPHARM’S actual cost as determined in accordance with Exhibit D attached to the Original Agreement; and (b) delivered by ETHYPHARM within thirty (30) days of ETHYPHARM’s receipt of RELIANT’s order therefor. [*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
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Related to Registration Batches

  • Registration, etc Each Pledgor agrees that, upon the occurrence and during the continuance of an Event of Default hereunder, if for any reason the Collateral Agent desires to sell any of the Pledged Securities of the Borrower at a public sale, it will, at any time and from time to time, upon the written request of the Collateral Agent, use its best efforts to take or to cause the issuer of such Pledged Securities to take such action and prepare, distribute and/or file such documents, as are required or advisable in the reasonable opinion of counsel for the Collateral Agent to permit the public sale of such Pledged Securities. Each Pledgor further agrees to indemnify, defend and hold harmless the Collateral Agent, each other Secured Party, any underwriter and their respective officers, directors, affiliates and controlling persons from and against all loss, liability, expenses, costs of counsel (including, without limitation, reasonable fees and expenses to the Collateral Agent of legal counsel), and claims (including the costs of investigation) that they may incur insofar as such loss, liability, expense or claim arises out of or is based upon any alleged untrue statement of a material fact contained in any prospectus (or any amendment or supplement thereto) or in any notification or offering circular, or arises out of or is based upon any alleged omission to state a material fact required to be stated therein or necessary to make the statements in any thereof not misleading, except insofar as the same may have been caused by any untrue statement or omission based upon information furnished in writing to such Pledgor or the issuer of such Pledged Securities by the Collateral Agent or any other Secured Party expressly for use therein. Each Pledgor further agrees, upon such written request referred to above, to use its best efforts to qualify, file or register, or cause the issuer of such Pledged Securities to qualify, file or register, any of the Pledged Securities under the Blue Sky or other securities laws of such states as may be requested by the Collateral Agent and keep effective, or cause to be kept effective, all such qualifications, filings or registrations. Each Pledgor will bear all costs and expenses of carrying out its obligations under this Section 12. Each Pledgor acknowledges that there is no adequate remedy at law for failure by it to comply with the provisions of this Section 12 and that such failure would not be adequately compensable in damages, and therefore agrees that its agreements contained in this Section 12 may be specifically enforced.

  • Number of Registrations SCG shall be entitled to request one registration of its Registrable Securities pursuant to Section 6(a) for each $100 million in Value of Registrable Securities Beneficially Owned by SCG on the date of such request.

  • Form S-3 Registration In case the Company shall receive from any Holder or Holders of Registrable Securities a written request or requests that the Company effect a registration on Form S-3 (or any successor to Form S-3) or any similar short-form registration statement and any related qualification or compliance with respect to all or a part of the Registrable Securities owned by such Holder or Holders, the Company will:

  • Form F-3 Registration In case the Company shall receive from any Holder or Holders of a majority of all Registrable Securities then outstanding a written request or requests that the Company effect a registration on Form F-3 (or an equivalent registration in a jurisdiction outside of the United States) and any related qualification or compliance with respect to all or a part of the Registrable Securities owned by such Holder or Holders, then the Company will:

  • Request for Form S-3 Registration After its initial public offering, the Company shall use its commercially reasonable efforts to qualify for registration on Form S-3 or any comparable or successor form or forms. After the Company has qualified for the use of Form S-3, in addition to the rights contained in the foregoing provisions of this Section 2 and subject to the conditions set forth in this Section 2.3, if the Company shall receive from a Holder or Holders of Registrable Securities a written request that the Company effect any registration on Form S-3 or any similar short form registration statement with respect to all or part of the Registrable Securities (such request shall state the number of shares of Registrable Securities to be disposed of and the intended methods of disposition of such shares by such Holder or Holders), the Company will take all such action with respect to such Registrable Securities as required by Section 2.1(a)(i) and (ii).

  • S-3 Registration (i) If at any time after the date hereof (i) any Investor requests (a “S-3 Request”) that the Company file a registration statement on Form S-3 or any successor form thereto for a public offering of all or any portion of the shares of Registrable Securities held by such Investor or Investors, the reasonably anticipated aggregate price to the public of which would exceed $1,000,000 or, if the foregoing is not satisfied, all of the Registrable Securities held by the Investors making the S-3 Request are included in the S-3 Registration and (ii) the Company is a registrant entitled to use Form S-3 or any successor form thereto to register such securities, then the Company shall, prepare and, as soon as practicable, but in no event later than the S-3 Filing Deadline, file with the SEC a Shelf Registration Statement on Form S-3 covering the resale of all of the Registrable Securities, provided that such Shelf Registration Statement shall register for resale at least the number of shares of Common Stock equal to the Required Registration Amount as of the date such Shelf Registration Statement is initially filed with the SEC; provided, that if such registration is for an Underwritten Offering, the terms of Sections 2(a)(ii) and 2(a)(iv) shall alternatively apply (and any reference to “Demand Registration” therein shall, for purposes of this Section 2(c), instead be deemed a reference to “S-3 Registration”), and provided further, that such request for an Underwritten Offering on Form S-3 shall be deemed a Demand Registration and subject to the limitations for purposes of Section 2(a)(iii). Such Shelf Registration Statement, and each other Shelf Registration Statement required to be filed pursuant to the terms of this Agreement (to the extent such Shelf Registration is not in connection with an Underwritten Offering), shall contain (except if otherwise directed by the Required Investors) the “Selling Stockholders” and “

  • Ship’s name and registration Each Borrower shall keep the Ship owned by it registered in its name under an Approved Flag; shall not do, omit to do or allow to be done anything as a result of which such registration might be cancelled or imperilled; and shall not change the name or port of registry of the Ship owned by it.

  • Limitations on Form S-3 Registration The Company shall not be obligated to effect, or take any action to effect, any such registration pursuant to this Section 2.3:

  • Registration Eligibility The Company is eligible to register the Registrable Securities for resale by the Buyers using Form S-3 promulgated under the 1933 Act.

  • Registration or Listing If any shares of Preferred Stock required to be reserved hereunder require registration with or approval of any governmental authority under any Federal or State law (other than any registration under the 1933 Act, as then in effect, or any similar Federal statute then enforced, or any state securities law, required by reason of any transfer involved in such conversion), or listing on any domestic securities exchange, before such shares may be issued upon conversion, the Company will, at its expense and as expeditiously as possible, use its best efforts to cause such shares to be duly registered, listed or approved for listing on such domestic securities exchange, as the case may be.

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