No Reference Filing Sample Clauses

No Reference Filing. 6.3.1 In the event that the Pfizer Licensors and their Affiliates, or the Company Licensees, their Affiliates and their Sublicensees, (as applicable) have not submitted a Reference Filing as described in Sections 6.1 or 6.2 (as applicable) to the applicable Regulatory Authorities, but have submitted such a Reference Filing to another Regulatory Authority, such Pfizer Licensor or Company Licensee (as applicable) or its applicable Affiliate shall prepare and if allowable by Applicable Law, submit a proprietary dossier of the CMC Information and quality, nonclinical and clinical information to the extent Controlled by the applicable Party (the “Regulatory Dossier”) to the applicable Regulatory Authority to the extent necessary for such Regulatory Authority to approve, with respect to a Company Licensee, the Company Submissions and, with respect to a Pfizer Licensor, the Pfizer Submissions (each of a Pfizer Licensor and a Company Licensee, a “Filing Party”); provided that, if a Company Licensee is a Filing Party, the applicable Reference Filing has been submitted, and the information contained in the Regulatory Dossier exists, as of the Effective Date.
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No Reference Filing. 6.3.1 In the event that the Pfizer Licensors, their Affiliates and their Sublicensees or the Company Licensees and their Affiliates (as applicable) have not submitted a Reference Filing as described in Sections 6.1 or 6.2 (as applicable) to the applicable Regulatory Authorities, but have submitted such a Reference Filing to another Regulatory Authority, such Pfizer Licensor or Company Licensee (as applicable) or its applicable Affiliate shall prepare and if allowable by Applicable Law, submit a proprietary dossier of the CMC Information and quality, nonclinical and clinical information (the “Regulatory Dossier”) to the applicable Regulatory Authority to the extent necessary for such Regulatory Authority to approve, with respect to a Company Licensee, its Affiliates and its Sublicensees, the Company Submissions and, with respect to a Pfizer Licensor and its Affiliates, the Pfizer Submissions (each of a Pfizer Licensor and a Company Licensee, a “Filing Party”); provided that, if a Company Licensee is a Filing Party, the applicable Pfizer Licensor has submitted the applicable Reference Filing, and the information contained in the Regulatory Dossier exists, as of the Effective Date.
Sample 1

Related to No Reference Filing

  • Filing of Copies, References, Headings The original or a copy of this Declaration of Trust and of each restatement and/or amendment hereto shall be kept at the principal executive office of the Trust where any Shareholder may inspect it. Anyone dealing with the Trust may rely on a certificate by an officer of the Trust as to whether or not any such restatements and/or amendments have been made and as to any matters in connection with the Trust hereunder; and, with the same effect as if it were the original, may rely on a copy certified by an officer of the Trust to be a copy of this instrument or of any such restatements and/or amendments. In this Declaration of Trust and in any such restatements and/or amendments, references to this instrument, and all expressions of similar effect to “herein,” “hereof” and “hereunder,” shall be deemed to refer to this instrument as amended or affected by any such restatements and/or amendments. Headings are placed herein for convenience of reference only and shall not be taken as a part hereof or control or affect the meaning, construction or effect of this instrument. Whenever the singular number is used herein, the same shall include the plural; and the neuter, masculine and feminine genders shall include each other, as applicable. This instrument may be executed in any number of counterparts, each of which shall be deemed an original.

  • Filing of Copies, References, Headings, Rules of Construction The original or a copy of this Declaration of Trust shall be kept at the office of the Trust where it may be inspected by any Shareholder. Anyone dealing with the Trust may rely on a certificate by an officer of the Trust as to any matters in connection with the Trust hereunder; and, with the same effect as if it were the original, may rely on a copy certified by an officer of the Trust to be a copy of this Declaration of Trust. In this Declaration of Trust, references to this Declaration of Trust, and all expressions such as “herein”, “hereof” and “hereunder”, shall be deemed to refer to this Declaration of Trust as a whole and not to any particular article or section unless the context requires otherwise. Headings are placed herein for convenience of reference only and shall not be taken as a part hereof or control or affect the meaning, construction or effect of this Declaration of Trust. Whenever the singular number is used herein, the same shall include the plural; and the neuter, masculine and feminine genders shall include each other, as applicable. This Declaration of Trust and any document, consent or instrument referenced in or contemplated by this Declaration of Trust or the By-Laws may be executed in any number of counterparts, each of which shall be deemed an original but all of which together will constitute one and the same instrument. To the extent permitted by the 1940 Act, (i) any document, consent, instrument or notice referenced in or contemplated by this Declaration of Trust or the By-Laws that is to be executed by one or more Trustees may be executed by means of original, facsimile or electronic signature and (ii) any document, consent, instrument or notice referenced in or contemplated by this Declaration of Trust or the By-Laws that is to be delivered by one or more Trustees may be delivered by facsimile or electronic means (including e-mail), unless, in the case of either clause (i) or (ii), otherwise determined by the Trustees. The terms “include,” “includes” and “including” and any comparable terms shall be deemed to mean “including, without limitation.” Any reference to any statute, law, code, rule or regulation shall be deemed to refer to such statute, law, code, rule or regulation as amended or restated from time to time and any successor thereto.

  • Incorporation of Recitals and Exhibits The Recitals and each exhibit attached hereto are hereby incorporated herein by reference.

  • Titles and References All references in this Deposit Agreement to exhibits, articles, sections, subsections, and other subdivisions refer to the exhibits, articles, sections, subsections and other subdivisions of this Deposit Agreement unless expressly provided otherwise. The words "this Deposit Agreement", "herein", "hereof", "hereby", "hereunder", and words of similar import refer to the Deposit Agreement as a whole as in effect between the Company, the Depositary and the Holders and Beneficial Owners of ADSs and not to any particular subdivision unless expressly so limited. Pronouns in masculine, feminine and neuter gender shall be construed to include any other gender, and words in the singular form shall be construed to include the plural and vice versa unless the context otherwise requires. Titles to sections of this Deposit Agreement are included for convenience only and shall be disregarded in construing the language contained in this Deposit Agreement. References to "applicable laws and regulations" shall refer to laws and regulations applicable to ADRs, ADSs or Deposited Securities as in effect at the relevant time of determination, unless otherwise required by law or regulation.

  • No Strict Construction; Headings This Agreement has been prepared jointly and shall not be strictly construed against either Party. Ambiguities, if any, in this Agreement shall not be construed against any Party, irrespective of which Party may be deemed to have authored the ambiguous provision. The headings of each Article and Section in this Agreement have been inserted for convenience of reference only and are not intended to limit or expand on the meaning of the language contained in the particular Article or Section.

  • Table of Contents and Section Headings The table of contents and the Section and subsection headings herein are intended for convenience only and shall be ignored in construing this Agreement.

  • Headings; References The article, section and paragraph headings contained in this Agreement are for reference purposes only and shall not affect in any way the meaning or interpretation of this Agreement. All references herein to "Articles" or "Sections" shall be deemed to be references to Articles or Sections hereof unless otherwise indicated.

  • Captions; Articles and Sections The captions contained in this Agreement are for reference purposes only and are not part of this Agreement. Unless otherwise indicated, all references to particular Articles or Sections shall mean and refer to the referenced Articles and Sections of this Agreement.

  • Entire Agreement; Headings This Agreement embodies the entire agreement of the parties respecting the matters within its scope and may be modified only in writing. Section headings in this Agreement are included herein for convenience of reference only and shall not constitute a part of this Agreement for any other purpose.

  • CROSS-REFERENCE TABLE Trust Indenture Act Section Indenture Section 310 (a)(1) 7.10 (a)(2) 7.10 (a)(3) N.A.

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