Development of Line Extensions Sample Clauses

Development of Line Extensions. Until the expiration of the last to expire Valid Claim of any Licensed Product Patents owned by LEL or its Affiliates, whenever a Party has a proposal for the development of any Line Extension, such Party shall submit a Development Request to the other Party for such Line Extension. Within sixty (60) days of being notified of such Development Request, the other Party shall submit a proposal at industry standard terms and conditions for the development of such Line Extension. The compensation payable for such development of a Line Extension shall be as provided under Section 11.3. [Redacted] LEL shall have the right to subcontract the development of any Line Extension under a Development Agreement to its Affiliates or a Third Party developer.
Sample 1
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Development of Line Extensions. (a) Should the Steering Committee decide to pursue any Line Extension, ANIKA shall be responsible for and shall use commercially reasonable efforts to conduct the Product Development of such Line Extensions pursuant to applicable Product Development plan(s) and budget(s) that shall be prepared by ANIKA, which plan(s) and budget(s) shall address specifications and timing and shall be agreed to, and adjusted from time to time, as appropriate, by the Steering Committee; provided, however, that GALDERMA shall provide reasonable assistance to ANIKA with such Product Development efforts. The Parties currently intend that one of the Line Extensions to be pursued will be a [********************] product. GALDERMA shall bear all reasonable and reasonably documented costs and expenses associated with Clinical Development of any such Line Extension, including without limitation ANIKA’s reasonable internal and out-of-pocket expenses associated with such Clinical Development, costs of hiring contract research organizations and all fees and expenses associated with any Regulatory Approval for any such Line Extension. If such costs and expenses exceed the budget for such Clinical Development approved by the Steering Committee, then such excess shall be borne by (i) GALDERMA, if such excess resulted from a change in Specifications or a change in the agreed Clinical Development plan requested by GALDERMA or required by the FDA or any other regulatory authority, or requested by ANIKA and agreed to by GALDERMA, or (ii) ANIKA, if such excess resulted from any mismanagement of the agreed upon budget. Confidential Treatment Requested Notwithstanding the foregoing, if the Steering Committee has approved a Line Extension pursuant to Section 2.2(b) and if GALDERMA decides not to proceed with the further Product Development of such Line Extension for any reason, then GALDERMA shall reimburse to ANIKA all of ANIKA’s reasonable and reasonably documented internal and out-of-pocket expenses associated with such Product Development that were not previously reimbursed, such reimbursement not to exceed the estimate of total Product Development costs presented to the Steering Committee pursuant to Section 2.2(b), as adjusted from time to time by the Steering Committee, and provided that, if ANIKA has commenced a clinical trial for any such Line Extension with respect to which GALDERMA decides not to proceed, such reimbursement shall include all of ANIKA’s reasonable and reasonably document...
Sample 1
Development of Line Extensions 
Sample 1

Related to Development of Line Extensions

  • Term Extension The term of this Employment Agreement (the "Term of --------------- this Employment Agreement") will commence as of March 1, 1998, and shall continue through February 28, 2001. On the third and each successive anniversary of the effective date of this Employment Agreement, the Term of this Employment Agreement shall be extended for an additional one (1) year period, unless either party gives notice of such party's intent not to extend the Term of this Employment Agreement not later than the anniversary date immediately preceding the anniversary date on which such extension will occur.. Termination of the Executive's employment pursuant to this Employment Agreement shall be governed by Articles 4 and 5.

  • Patent Extensions The Parties shall cooperate in obtaining patent term restoration (under but not limited to Drug Price Competition and Patent Term Restoration Act), supplemental protection certificates or their equivalents, and patent term extensions with respect to the BRI Patents in any country or region in the Licensed Territory where applicable, provided, that Ultragenyx shall have the final decision making authority on the foregoing.

  • 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.

  • 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.

  • Lease Extension If this Lease shall not have been terminated --------------- pursuant to any provisions hereof and there is no Material Breach (as defined herein) by Tenant hereunder at the time set for exercise of the Extension Terms (as herein defined) and at the time set for commencement thereof, then Tenant may, at Tenant's option, extend the term of this Lease for five (5) successive additional terms of four (4) years each (each an "Extension Term," collectively the "Extension Terms") commencing on the expiration of the original term, or the immediately preceding Extension Term, as the case may be. Tenant may exercise such option by giving Landlord written notice at least ten (10) months prior to the expiration of the original or the immediately preceding Extension Term, as the case may be. Upon the giving by Tenant to Landlord of such written notice and the compliance by Tenant with the foregoing provisions of this Paragraph 15, this Lease shall be deemed to be automatically extended upon all the Covenants, agreements, terms, provisions and conditions set forth in this Lease, except that Base Rent for each such Extension Term shall be as provided on Exhibit D. If Tenant fails or omits to so give to Landlord the written notice referred to above, Landlord shall provide Tenant with written notice of Tenant's failure to exercise the Extension Term, and upon receipt of such notice, Tenant shall be allowed fifteen (15) days to exercise the extension option allowed for herein. If Landlord fails to provide such notice, Tenant's renewal option shall expire upon the expiration of the then current term. Failure to respond to Landlord's notice within such fifteen (15) days shall be deemed to be a waiver by Tenant of its extension option hereunder.

  • Development Schedule The schedule for design and development of the "BASE BUILDING WORK" (as defined below) and the "TENANT IMPROVEMENTS" (as defined below), including, without limitation, the time periods for preparation, delivery, review, and approval of construction documents and performance pursuant to such documents, shall be in accordance with the Development Schedule attached hereto as Schedule A, subject to adjustment as mutually agreed by the parties in writing or as provided in this Work Letter (the "DEVELOPMENT SCHEDULE").

  • Development and Commercialization Subject to Sections 4.6 and 4.7, Fibrocell shall be solely responsible for the development and Commercialization of Fibrocell Products and Improved Products. Fibrocell shall be responsible for all costs incurred in connection with the Fibroblast Program except that Intrexon shall be responsible for the following: (a) costs of establishing manufacturing capabilities and facilities in connection with Intrexon’s manufacturing obligation under Section 4.6 (provided, however, that Intrexon may include an allocable portion of such costs, through depreciation and amortization, when calculating the Fully Loaded Cost of manufacturing a Fibrocell Product, to the extent such allocation, depreciation, and amortization is permitted by US GAAP, it being recognized that the majority of non-facilities scale-up costs cannot be capitalized and amortized under US GAAP); (b) costs of basic research with respect to the Intrexon Channel Technology and Intrexon Materials (i.e., platform improvements) but, for clarity, excluding research described in Section 4.7 or research requested by the JSC for the development of a Fibrocell Product or an Improved Product (which research costs shall be reimbursed by Fibrocell); (c) [*****]; and (d) costs of filing, prosecution and maintenance of Intrexon Patents. The costs encompassed within subsection (a) above shall include the scale-up of Intrexon Materials and related active pharmaceutical ingredients for clinical trials and Commercialization of Fibrocell Products undertaken pursuant to Section 4.6, which shall be at Intrexon’s cost whether it elects to conduct such efforts internally or through Third Party contractors retained by either Intrexon or Fibrocell (with Intrexon’s consent).

  • 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 THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. 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.

  • Development Plan As defined in Section 3.2(a).

  • Development Budget Attached hereto as Exhibit "B" and incorporated herein by this reference is the Development Budget in an amount equal to $_____________. Owner acknowledges and represents that the attached Development Budget includes the total costs and expenses to acquire, develop, renovate and construct the Real Property and the Apartment Housing.

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