Hospira’s Right to Review Sample Clauses

Hospira’s Right to Review. Hospira shall have the right to review and consult on those portions of Hologic’s proposed regulatory submissions relating to Hospira’s packaging or manufacturing procedures before the submissions are filed with the FDA. Hospira shall complete its review of the submissions as quickly as commercially reasonable but no later than [***] days after receipt of a proposed regulatory submission. Hospira shall consult with and advise Hologic in responding to questions from Regulatory Authorities regarding Hologic’s submission(s) for Product. Hologic shall be the sole owner of any regulatory submission filed pursuant to this Agreement. Exhibit 3.1 includes Hospira’s costs of review for one FDA filing and associated amendments. Hologic shall provide to Hospira for its files a final copy of the CMC section of any such regulatory submission(s). [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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Hospira’s Right to Review. Tercica shall exert reasonable efforts to file regulatory submission(s) in order to obtain the First Regulatory Approval from the FDA. Hospira shall have the right to review and consult on those portions of Company’s proposed regulatory submissions relating to Hospira’s packaging or manufacturing procedures before the submissions are filed with appropriate Regulatory Authorities. Any such portions of submissions in a language other than English shall be provided to Hospira by Company with an accompanying English translation. Hospira shall complete its review of the submissions within sixty (30) days for submissions in English, or within ninety (60) days for submissions not in English, after receipt of a proposed regulatory submission. Hospira shall consult with and advise Company in responding to questions from the Regulatory Authorities regarding such submission(s) to Regulatory Authorities. Company shall be the sole owner of any regulatory submission filed pursuant to this Agreement. Company shall reimburse Hospira for Hospira’s review and consultation under this Section at the rate of [ * ] per hour. Company shall provide to Hospira for its files a final copy of the CMC section of any such regulatory submission(s).
Hospira’s Right to Review. Company shall be the sole owner of any regulatory submission filed pursuant to this Agreement. Hospira shall have the right to review and consult with Company on those portions of Company's proposed regulatory submissions relating to Hospira's packaging or manufacturing procedures before the submissions are filed with appropriate Regulatory Authorities. Hospira shall complete its review of the submissions [*] after receipt of a proposed regulatory submission. [*]. Hospira shall consult with and advise Company in responding to questions from Regulatory Authorities regarding Company's submission(s) for Product. It is anticipated that Hospira's review and consultation activities under this Section will not ordinarily exceed [*]. In the event that such activities do exceed [*] for reasons not due to Hospira's fault or negligence, Hospira shall provide Company with cost estimates for any required additional review and consultation activities. If Company approves such costs in writing, Company shall reimburse Hospira for such additional review and consultation activities under this Section at the rate of [*]. Company shall provide to Hospira for its files a final copy of the drug product CMC section of any such regulatory submission(s).
Hospira’s Right to Review. Hospira shall have the right to review and consult on those portions of Genzyme’s proposed regulatory submissions relating to Hospira’s packaging or [**] = 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. manufacturing procedures before the submissions are filed with the appropriate Regulatory Authorities. Hospira shall complete its review of the submissions within [**] days for submissions in English, or within [**] days for submissions not in English, following receipt of a proposed regulatory submission. Hospira shall consult with and advise Genzyme in responding to questions from Regulatory Authorities regarding Genzyme’s submission(s) for Products. Genzyme shall be the sole owner of any regulatory submission filed pursuant to this Agreement. Genzyme shall reimburse Hospira for Hospira’s review and consultation under this Section 4.1 at the rate of [**] per hour. Genzyme shall provide to Hospira for its files a final copy of the CMC section of any such regulatory submission(s).
Hospira’s Right to Review. (a) Hospira shall have the right to review and consult on those portions of OBI’s proposed regulatory submissions relating to Hospira’s packaging or manufacturing procedures before the submissions are filed with appropriate Regulatory Authorities. Hospira shall complete its review of any English-language submissions within sixty (60) days after receipt. The parties will agree on the time required for Hospira’s review of submissions in other than English language without translation, which will extend Hospira’s review period for the purpose of providing a reasonable period for document translation.

Related to Hospira’s Right to Review

  • Right to Review After receiving written notice of the denial of a claim, a claimant or his representative shall be entitled to:

  • Right to Relet Should Tenant be in default as provided in Section 18.1 above and Landlord elects to reenter the Premises, as herein provided, or should it take possession of the Premises pursuant to legal proceedings or pursuant to any notice provided for by law, or should Tenant fail to cure a default (after expiration of the applicable notice period) it may either terminate this Lease or may, from time to time without terminating this Lease, make such alterations and repairs as may be necessary in order to relet the Premises, and relet the Premises or any part thereof for such term or terms (which may be for a term extending beyond the Lease Term) and at such rental or rentals and upon such other terms and conditions as Landlord, in its sole discretion may deem advisable. Upon each such reletting, all rentals, and other consideration, received by Landlord therefrom shall be applied: first, to any indebtedness other than Base Rent due hereunder from Tenant to Landlord; second, to pay any actual and reasonable costs and expenses of reletting, including Additional Rent, concessions, or abatements, actual and reasonable brokers' fees and attorneys' fees, and costs of such alterations and repairs (Tenant shall not be liable for any such cost or expense if caused by Landlord) provided that the cost of such alterations, for purposes of this section, shall not exceed the cost of restoring the Premises to so called "Vanilla Shell" condition (hereinafter defined); third, to the payment of Base Rent due and unpaid hereunder; and the residue, if any, shall be held by Landlord and applied in payment of future Base Rent as the same may become due and payable hereunder. "

  • RIGHT TO RELOCATE Sublandlord may, at any time, relocate any of Subtenant’s Subleased Premises to another area of the Building in which such Subleased Premises are located (“New Premises”), provided the New Premises shall have, if possible, approximately the same rentable square footage of space; notwithstanding the foregoing, Sublandlord shall have the right to offer Subtenant New Premises with lesser square footage than the original Subleased Premises (but in no event lesser than 70% of the original Subleased Premises) if Sublandlord’s store size has been or is in the process of being reduced. Provided that Subtenant is open and operating at the applicable Subleased Premises at the time Sublandlord exercises the rights granted by this Section, Sublandlord agrees to pay all reasonable moving expenses incurred by Subtenant incident to such relocation and for improving the New Premises so that the New Premises are similar to the then existing Subleased Premises. Sublandlord shall provide Subtenant with at least sixty (60) days prior written notice before making such relocation demand. Subtenant shall cooperate with Sublandlord in all reasonable ways to facilitate the move and shall be responsible for moving all of its inventory and other goods to the New Premises. If Subtenant fails to so cooperate, Sublandlord shall be relieved of all responsibility for damage or injury to Subtenant or its property during such move, except as may be caused by Sublandlord’s actual negligence. Notwithstanding the foregoing, if the New Premises identified by Sublandlord is not acceptable to Subtenant, then Subtenant may elect to terminate this Sublease solely with respect to such Subleased Premises by written notice to Sublandlord within thirty (30) calendar days after receipt of Sublandlord’s written notice of such relocation, with such termination to be effective sixty (60) days after Subtenant’s election. Upon the completion of a relocation, the Rent shall be adjusted to reflect the actual square footage of the New Premises and the New Premises shall be deemed to have replaced the applicable Subleased Premises for all purposes under this Sublease.

  • Right to Company Materials The Executive agrees that all styles, designs, lists, materials, books, files, reports, correspondence, records, and other documents (“Company Materials”) used, prepared, or made available to the Executive shall be and shall remain the property of the Company. Upon the termination of employment or the expiration of this Agreement, the Executive shall immediately return to the Company all Company Materials, and the Executive shall not make or retain any copies thereof.

  • Right to Revoke Employee may revoke this Agreement by notice to Company, in writing, received within seven (7) days of the date of its execution by Employee (the “Revocation Period”). Employee agrees that Employee will not receive the benefits provided by this Agreement if Employee revokes this Agreement. Employee also acknowledges and agrees that if Company has not received from Employee notice of Employee’s revocation of this Agreement prior to the expiration of the Revocation Period, Employee will have forever waived Employee’s right to revoke this Agreement, and this Agreement shall thereafter be enforceable and have full force and effect.

  • Right to Seek Assurance The Transfer Agent may refuse to transfer, exchange or redeem shares of the Fund or take any action requested by a shareholder until it is satisfied that the requested transaction or action is legally authorized or until it is satisfied there is no basis for any claims adverse to the transaction or action. It may rely on the provisions of the Uniform Act for the Simplification of Fiduciary Security Transfers or the Uniform Commercial Code. The Company shall indemnify the Transfer Agent for any act done or omitted to be done in reliance on such laws or for refusing to transfer, exchange or redeem shares or taking any requested action if it acts on a good faith belief that the transaction or action is illegal or unauthorized.

  • Right to Review Tax Returns The Responsible Company with respect to any Tax Return shall make such Tax Return and related workpapers available for review by the other Company, if requested, to the extent (a) such Tax Return relates to Taxes for which the requesting party may be liable, (b) such Tax Return relates to Taxes for which the requesting party may be liable in whole or in part or for any additional Taxes owing as a result of adjustments to the amount of Taxes reported on such Tax Return, (c) such Tax Return relates to Taxes for which the requesting party may have a claim for Tax Benefits under this Agreement, or (d) the requesting party reasonably determines that it must inspect such Tax Return to confirm compliance with the terms of this Agreement. The Responsible Company shall make such Tax Return available for review as required under this paragraph at least thirty (30) days prior to the due date for filing such Tax Returns to provide the requesting party with a meaningful opportunity to analyze and comment on such Tax Returns and have such Tax Returns modified before filing. The Companies shall attempt in good faith to resolve any issues arising out of the review of such Tax Returns. Issues that cannot be resolved by the Companies shall be resolved in the manner set forth in Section 14; provided, however, that such Tax Return shall be timely filed in the manner prepared by the Responsible Company if the issues cannot be resolved prior to the time required by law (including extensions) for the filing of such Tax Return.

  • RECORDS; RIGHT TO AUDIT (a) The Sub-Adviser agrees to maintain in the form and for the period required by Rule 31a-2 under the 1940 Act, all records relating to the Fund's investments made by the Sub-Adviser that are required to be maintained by the Fund pursuant to the requirements of Rule 31a-1 under the 1940 Act. The Sub-Adviser agrees that all records that it maintains on behalf of the Fund are the property of the Fund, and the Sub-Adviser will surrender promptly to the Fund any such records upon the Fund's request; provided, however, that the Sub-Adviser may retain a copy of such records. In addition, for the duration of this Agreement, the Sub-Adviser shall preserve for the periods prescribed by Rule 31a-2 under the 1940 Act any such records as are required to be maintained by it pursuant to this Agreement and shall transfer all such records to any entity designated by the Adviser upon the termination of this Agreement.

  • Reservation of Right to Revise Transaction Buyer may at any time change the method of effecting the acqui- sition of Seller or Seller's Subsidiaries by Buyer and Seller shall cooperate in such efforts (including without limitation (a) the provisions of this Article I and (b) causing the merger of Roosevelt Bank, a wholly owned subsidiary of Seller ("Seller Bank") and/or any of the Banks (as defined herein) with any depository institution which is a Subsidiary of Buyer (any such merger together with the Merger being referred to herein as the "Transactions")) if and to the extent it deems such change to be desirable, including without limitation to provide for a merger of Seller directly into Buyer, in which Buyer is the surviving corporation, provided, however, that no such change shall (A) alter or change the amount or kind of consideration to be issued to holders of Seller Common Stock as provided for in this Agreement (the "Merger Consideration"), (B) adversely affect the tax treatment to Seller's stockholders as a result of receiving the Merger Consideration or (C) materially delay receipt of any approval referred to in Section 6.01(b) or the consummation of the transactions contemplated by this Agree- ment.

  • Licensee’s Right to Terminate Licensee may, at its option, without prejudice to any other remedies it may have, terminate this agreement by giving written notice of such termination to Licensor as follows: (a) immediately, in the event that Licensor abandons the Licensed Marks or otherwise ceases to support the Licensed Marks in Licensor's business; or (b) immediately in the event of the occurrence of a Bankruptcy with respect to Licensor; or (c) immediately in the event of an occurrence of termination pursuant to Section 13.2(d).

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