Promotion of the FDC Products Sample Clauses

Promotion of the FDC Products. The Parties acknowledge and agree, that based on their assumptions as of the Effective Date regarding (a)[*], in each case with respect to the first FDC Product and (b) [*] (collectively, the “FDC Launch Assumptions”), Forest, its Affiliates and Sublicensees, collectively shall [*]. If [*], [*] Commercially Reasonable Efforts diligence obligation set forth in Section 5.1 with respect to Commercialization of the FDC Products prior to [*] of the First Commercial Launch of the first FDC Product. In the event of a material change in any of the FDC Launch Assumptions, as compared with the relevant conditions as of the Effective Date, such that it would no longer constitute Commercially Reasonable Efforts for Forest to undertake [*], Forest [*]; provided that [*] to [*] with respect to the Commercialization of a FDC Product in the Field in the Territory. Upon Adamas’ request, Forest shall review and discuss with Adamas the nature of any [*] and any basis for any [*]. Any disagreement between the Parties as to whether [*] and [*] with respect to the Commercialization of a FDC Product [*] shall be [*]. If Forest fails to meet [*] for any FDC Product, Adamas shall have the right to [*] and [*], including [*] in accordance with [*]. In connection with any [*], each Party shall have the right to [*] with respect to the [*] or [*].
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Promotion of the FDC Products. The Parties acknowledge and agree, that based on their assumptions as of the Effective Date regarding (a)(i) the payer environment and formulary coverage, (ii) anticipated product label, (iii) industry marketing practices, (iv) expected approval timing, (v) expected duration of exclusivity, and (vi) commercial potential [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. and market conditions, in each case with respect to the first FDC Product and (b) continued level of concomitant use by physicians of Memantine and Donepezil to treat Alzheimer’s disease (collectively, the “FDC Launch Assumptions”), Forest, its Affiliates and Sublicensees, collectively shall (x) [ * ] during the period that begins on the First Commercial Launch of the first FDC Product and ends [ * ] and (y) [ * ] directly related to the FDC Franchise (excluding [ * ] set forth in clause (x)) in the Field in the Territory prior to [ * ] of the First Commercial Launch of the first FDC Product ((x) and (y) collectively, the “Launch Commitment”) If the obligations set forth in (x) and (y) are performed, Forest shall be deemed to have satisfied its Commercially Reasonable Efforts diligence obligation set forth in Section 5.1 with respect to Commercialization of the FDC Products prior to [ * ] of the First Commercial Launch of the first FDC Product. In the event of a material change in any of the FDC Launch Assumptions, as compared with the relevant conditions as of the Effective Date, such that it would no longer constitute Commercially Reasonable Efforts for Forest to undertake the Launch Commitment, Forest may make any adjustments, consistent with its Commercially Reasonable Efforts obligation in Section 5.1, to the Launch Commitment to account for such change (or changes taken as a whole) upon prior written notice to Adamas of such material change and the basis for any corresponding adjustment; provided that Forest may not adjust the Launch Commitment to provide for a level of efforts and spend that would be less than Commercially Reasonable Efforts with respect to the Commercialization of a FDC Product in the Field in the Territory. Upon Adamas’ request, Forest shall review and discuss with Adamas the nature of any change in any of the FDC Launch Assumptions and any basis for any corresponding adjustment to the ...
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Related to Promotion of the FDC Products

  • Commercialization Intrexon shall have the right to develop and Commercialize the Reverted Products itself or with one or more Third Parties, and shall have the right, without obligation to Fibrocell, to take any such actions in connection with such activities as Intrexon (or its designee), at its discretion, deems appropriate.

  • Licensed Products Lessee will obtain no title to Licensed Products which will at all times remain the property of the owner of the Licensed Products. A license from the owner may be required and it is Lessee's responsibility to obtain any required license before the use of the Licensed Products. Lessee agrees to treat the Licensed Products as confidential information of the owner, to observe all copyright restrictions, and not to reproduce or sell the Licensed Products.

  • Commercialization Activities Within North America, the Parties will use Commercially Reasonable Efforts to Commercialize Licensed Products in the Field. In addition, within North America and subject to Section 2.7.6, the Parties will use Commercially Reasonable Efforts to conduct the Commercialization activities assigned to them pursuant to the Commercialization Plan/Budget, including the performance of detailing in accordance therewith. In conducting the Commercialization activities, the Parties will comply with all Applicable Laws, applicable industry professional standards and compliance policies of Celgene which have been previously furnished to Acceleron, as the same may be updated from time to time and provided to Acceleron. Neither Party shall make any claims or statements with respect to the Licensed Products that are not strictly consistent with the product labeling and the sales and marketing materials approved for use pursuant to the Commercialization Plan/Budget.

  • Commercialization License Subject to the terms of this Agreement, including without limitation Section 2.2 and Theravance's Co-Promotion rights in Section 5.3.2, Theravance hereby grants to GSK, and GSK accepts, an exclusive license under the Theravance Patents and Theravance Know-How to make, have made, use, sell, offer for sale and import Alliance Products in the Territory.

  • Competing Products The provisions of Section 21 are set forth on attached Exhibit H and are incorporated in this Section 21 by this reference.

  • New Products You agree to comply with NASD Notice to Members 5-26 recommending best practices for reviewing new products.

  • Commercialization Plans As soon as practicable after formation of the JCC (following Acucela’s exercise of an Opt-In Right under Section 3.1), the JCC shall prepare and approve the initial Commercialization Plan for Commercialization of the Licensed Product for the Initial Indication in the Initial Formulation (and, if applicable, any New Formulation or Other Indication Product) in the Territory. The Parties shall use Commercially Reasonable Efforts to ensure that such initial Commercialization Plan for Commercialization of the Licensed Product for the Initial Indication in the Initial Formulation is consistent with the general Commercialization Plan outline set forth in Exhibit C attached hereto and incorporated herein (the “General Commercialization Plan Outline”). The JCC shall prepare and approve a separate Commercialization Plan for Commercialization of Licensed Product for the Initial Indication in the Initial Formulation in the Territory and for Commercialization of each Other Indication Product and New Formulation (if any) in the Territory, and shall update and amend each Commercialization Plan not less than annually or more frequently as needed to take into account changed circumstances or completion, commencement or cessation of Commercialization activities not contemplated by the then-current Commercialization Plan. Amendments and revisions to the Commercialization Plan shall be reviewed and discussed, in advance, by the JCC, and Otsuka agrees to consider proposals and suggestions made by Acucela regarding amendments and revisions to the Commercialization Plan. Any amendment or revision to the Commercialization Plan that provides for an increase or decrease in the number of FTEs for any Phase 3b Clinical Trials or Post-Approval Studies as compared to the previous version of the Commercialization Plan, or that provides for addition or discontinuation of tasks or activities as compared to the previous version of the Commercialization Plan, or that moves forward the timetable for activities reflected in the Commercialization Plan, shall provide for a reasonable ramp-up or wind-down period, as applicable, to accommodate a smooth and orderly transition of Commercialization activities to the amended or revised Commercialization Plan. Each Commercialization Plan shall identify the goals of Commercialization contemplated thereunder and shall address Commercialization (including Co-Promotion) activities related to the Licensed Product (including, if applicable, any Other Indication Product), including:

  • Manufacturing (a) The Supplier shall without limitation be responsible, at no additional cost to the Purchaser, for: sourcing and procuring all raw materials for the Products; obtaining all necessary approvals, permits and licenses for the manufacturing of the Products; providing sufficient qualified staff and workers to perform the obligations under this Purchase Agreement; implementing and maintaining effective inventory and production control procedures with respect to the Products; and handling other matters as reasonably requested by the Purchaser from time to time.

  • Manufacturing and Marketing Rights The Company has not granted rights to manufacture, produce, assemble, license, market, or sell its products to any other person and is not bound by any agreement that affects the Company's exclusive right to develop, manufacture, assemble, distribute, market, or sell its products.

  • Product ACCEPTANCE Unless otherwise provided by mutual agreement of the Authorized User and the Contractor, Authorized User(s) shall have thirty (30) days from the date of delivery to accept hardware products and sixty (60) days from the date of delivery to accept all other Product. Where the Contractor is responsible for installation, acceptance shall be from completion of installation. Failure to provide notice of acceptance or rejection or a deficiency statement to the Contractor by the end of the period provided for under this clause constitutes acceptance by the Authorized User(s) as of the expiration of that period. The License Term shall be extended by the time periods allowed for trial use, testing and acceptance unless the Commissioner or Authorized User agrees to accept the Product at completion of trial use. Unless otherwise provided by mutual agreement of the Authorized User and the Contractor, Authorized User shall have the option to run testing on the Product prior to acceptance, such tests and data sets to be specified by User. Where using its own data or tests, Authorized User must have the tests or representative set of data available upon delivery. This demonstration will take the form of a documented installation test, capable of observation by the Authorized User, and shall be made part of the Contractor’s standard documentation. The test data shall remain accessible to the Authorized User after completion of the test. In the event that the documented installation test cannot be completed successfully within the specified acceptance period, and the Contractor or Product is responsible for the delay, Authorized User shall have the option to cancel the order in whole or in part, or to extend the testing period for an additional thirty (30) day increment. Authorized User shall notify Contractor of acceptance upon successful completion of the documented installation test. Such cancellation shall not give rise to any cause of action against the Authorized User for damages, loss of profits, expenses, or other remuneration of any kind. If the Authorized User elects to provide a deficiency statement specifying how the Product fails to meet the specifications within the testing period, Contractor shall have thirty (30) days to correct the deficiency, and the Authorized User shall have an additional sixty (60) days to evaluate the Product as provided herein. If the Product does not meet the specifications at the end of the extended testing period, Authorized User, upon prior written notice to Contractor, may then reject the Product and return all defective Product to Contractor, and Contractor shall refund any monies paid by the Authorized User to Contractor therefor. Costs and liabilities associated with a failure of the Product to perform in accordance with the functionality tests or product specifications during the acceptance period shall be borne fully by Contractor to the extent that said costs or liabilities shall not have been caused by negligent or willful acts or omissions of the Authorized User’s agents or employees. Said costs shall be limited to the amounts set forth in the Limitation of Liability Clause for any liability for costs incurred at the direction or recommendation of Contractor.

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