PEDIATRIC EXTENSION Sample Clauses

PEDIATRIC EXTENSION. KING shall complete all additional studies of the Product which the AMC determines are or may be required to obtain pediatric labeling for the Product in the Territory. Upon completion of such studies, KING shall timely apply to the FDA for an exclusive pediatric extension with respect to the Product, or its equivalent, and shall use its Commercially Reasonable Efforts to pursue the granting of such extension. The costs of such studies shall be shared by the Parties in accordance with Section 9.5 hereof.
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PEDIATRIC EXTENSION. Completion of any additional studies of the Product(s) which are or may be required to obtain pediatric labeling for the Product(s) in the Territory shall be performed in King’s sole discretion. The costs of any such studies approved by both Parties and conducted pursuant to the Prior Agreement shall be shared by the Parties in accordance with Section 9.5 hereof. It is understood and agreed by the Parties that Wyeth’s share of such costs for the first and second quarters of 2006 shall include [***] dollars and [***] cents ($[***]) due for work performed in the first quarter of 2006 and up to [***]dollars[***]and [***] cents ($[***]) due for work performed in the second quarter of 2006. King shall be responsible, at its sole expense, for conducting any future studies which may be required or desirable to obtain any pediatric labeling for any Product(s). The Parties agree to transition work related to the publication of the [***] in accordance with Section 20 of the Transition Plan.
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Related to PEDIATRIC EXTENSION

  • Renewal, Extension The renewal or extension of any Letter of Credit shall, for purposes hereof, be treated in all respects the same as the issuance of a new Letter of Credit hereunder.

  • Automatic Extension At the end of the initial term and any subsequent ------------------- term, this Agreement shall automatically renewed for a five (5) year term unless one of the parties provides the other party with written notice of intent not to renew, not less than one hundred eighty (180) day prior to the expiration of the then current term.

  • Term Extension It is understood and agreed that the State may extend the Term an additional period of time, not to exceed one hundred-eighty (180) days beyond the expiration date of this Grant Contract, under the same terms and conditions. In no event, however, shall the maximum Term, including all extensions or renewals, exceed a total of sixty (60) months.

  • Territorial Extension At the time of signature of this Agreement, or at any time thereafter, the provisions of this Agreement may be extended to such territories for whose international relations the Government of the United Kingdom are responsible as may be agreed between the Contracting Parties in an Exchange of Notes.

  • Patent Term Extension The Parties will cooperate in selecting a patent within the Patent Rights to seek a term extension for or supplementary protection certificate under in accordance with the applicable laws of any country. Each Party agrees to execute any documents and to take any additional actions as the other Party may reasonably request in connection therewith.

  • Patent Term Extensions The Parties shall use reasonable efforts to obtain all available supplementary protection certificates, patent term restorations, and other extensions (collectively, “Extensions”) of the Acceleron Patent Rights and Joint Patent Rights (including those available under the Xxxxx-Xxxxxx Act). Each Party shall execute such authorizations and other documents and take such other actions as may be reasonably requested by the other Party to obtain such Extensions. The Parties shall cooperate with each other in gaining Extensions wherever applicable to Acceleron Patent Rights or Joint Patent Rights. The holder of the applicable NDA may determine what Extensions of any such Patent Rights shall be made; provided that, if in any country such holder has an option to extend the patent term for only one of several patents, the first Party shall consult with the other Party before making the election. If more than one patent is eligible for such an Extension, the Parties shall select in good faith a strategy that shall maximize patent protection and commercial value for each Licensed Product. All filings for such Extensions, as determined by the holder of the applicable NDA, shall be made by the Party to whom responsibility for Prosecution of the Acceleron Patent Rights or Joint Patent Rights are assigned, and the owner of record of the applicable Patent Right shall assist with such filings; provided that, in the event that the Party to whom such responsibility is assigned elects not to file for an Extension, such Party shall (a) inform the other Party of its intention not to file, (b) grant the other Party the right to file for such Extension in the Patent Rights’ owner’s name, and (c) provide all necessary assistance in connection therewith. The Parties acknowledge and agree that (i) pursuant to the Shire Agreement, Shire and Acceleron will consult in selecting Patent Rights to extend the patent term with respect to “Licensed Products” under the Shire Agreement, and Shire shall make the decision in all countries of the world other than those of North America with respect to such “Licensed Products” under the Shire Agreement, and the filings for Extensions with respect thereto will be made by the party who is responsible for Prosecuting Patent Rights under the Shire Agreement, and, as such, Celgene’s rights under this Section 8.9 are subject to Shire’s prior rights; and (ii) Acceleron shall keep Celgene informed of all elections with respect to Extensions made pursuant to the Shire Agreement that affect Acceleron Patent Rights, and, to the extent that Shire is making any such elections, Acceleron shall use commercially reasonable efforts to cause Shire to take the actions specified by this Section 8.9 in a manner consistent with the Shire Agreement; provided that Acceleron will not be in breach of its obligations under this Section 8.9 if, after using such commercially reasonable efforts, it is unable to comply with such obligations because of actions taken or not taken by Shire.

  • Contract Term Extension “Contract Term Extension” means an extension of the term of this contract, at the request of Purchaser, under this Subsection. This Subsection does not obligate Contracting Officer to grant Contract Term Extension.

  • Modification, Extension The issuance of any supplement, modification, amendment, renewal, or extension to any Letter of Credit shall, for purposes hereof, be treated in all respects the same as the issuance of a new Letter of Credit hereunder.

  • Listing Period Extension The Commission shall be due if the Property is sold, conveyed, exchanged, optioned, or otherwise transferred within _ _ days (“Extension Period”) after the expiration of the Listing Period to anyone with whom the Broker or Agency has negotiated unless the Property is listed, in good faith, with another real estate agency. The term “negotiation” shall include providing information about the Property, showing the Property, or presenting an offer on the Property. All rights under this Section shall terminate upon the expiration of the Extension Period.

  • Modification, Extension and Renewal of Options The Board or a duly appointed committee thereof, may modify, extend or renew this Option or accept the surrender thereof (to the extent not theretofore exercised) and authorize the granting of a new option in substitution therefore (to the extent not theretofore exercised), subject at all times to the Code and applicable securities laws. Notwithstanding the foregoing provisions of this Section 12, no modification shall, without the consent of the Recipient, alter to the Recipient’s detriment or impair any rights of Recipient hereunder.

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