INFORMATION AND REPORTS DURING DEVELOPMENT AND COMMERCIALIZATION Sample Clauses

INFORMATION AND REPORTS DURING DEVELOPMENT AND COMMERCIALIZATION. Schering and Alliance will disclose and make available (subject to any confidentiality agreements or requirements of law) to each other without charge all preclinical, clinical, regulatory, pricing, sales and other Information, including copies of all preclinical and clinical reports, known by Schering or Alliance directly concerning the Product within the Field at any time during the term of this Agreement. Each Party shall own and maintain its own database of clinical trial data accumulated from all clinical trials of the Product for which it was responsible and of adverse drug event information for the Product. At the option of the requesting Party, such data shall be provided in a computer readable format by the providing Party, to the extent available, which shall also assist in the transfer and validation of such data to the receiving Party. Without limitation of the foregoing, each Party shall supply to the other the Information required by the other Party and requested by it (either as a routine practice or as a specific request) for purposes of compliance with regulatory requirements.
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INFORMATION AND REPORTS DURING DEVELOPMENT AND COMMERCIALIZATION. Schering and Techniclone will disclose and make available (subject to any confidentiality agreements or requirements of law) to each other without charge all preclinical, clinical, regulatory, and other Information, including copies of all preclinical and clinical reports, known by Schering or Techniclone directly concerning the Product within the Field at any time during the term of this Agreement. Each Party shall own and maintain its own database of clinical trial data accumulated from all clinical trials of the Product for which it was responsible and of adverse drug event information for the Product. At the option of the requesting Party, such data shall be provided in a computer readable or other electronic format by the providing Party, to the extent available, which shall also assist in the transfer and validation of such data to the receiving Party. Without limitation of the foregoing, each Party shall supply to the other the Information required by the other Party and requested by it (either as a routine practice or as a specific request) for purposes of compliance with regulatory requirements. With respect to information concerning Commercialization, Schering agrees to keep Techniclone regularly informed on all post marketing activities, but shall have no obligation, except as specifically set forth in this Agreement, to share pricing, marketing or sales information with Techniclone.
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INFORMATION AND REPORTS DURING DEVELOPMENT AND COMMERCIALIZATION. 7.1.1 To the extent permitted by law, GS and LGLS will each regularly disclose and make available to the other without charge all Information (including, without limitation, copies of all pre-clinical and clinical reports and training, marketing and promotional materials) known to them. Without limiting the foregoing, promptly following the Effective Date, and at reasonable intervals thereafter, LGLS shall disclose and transfer to GS all LGLS Know-how and GLAXO Know-how and GS shall disclose and transfer to LGLS all GS Know-how.
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INFORMATION AND REPORTS DURING DEVELOPMENT AND COMMERCIALIZATION. 7.1.1 To the extent necessary or useful to enable the Parties to perform their respective obligations or exercise their respective rights hereunder, GSK and Scios will each regularly disclose and make available to the other without charge all Information (including, without limitation, copies of all preclinical and clinical reports) known to them. Without limiting [*****] - A CONFIDENTIAL PORTION OF THE MATERIAL HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION the foregoing, promptly following the Effective Date, and at reasonable intervals thereafter, Scios shall disclose and transfer to GSK all Scios Know-how as is necessary or useful for the exercise by GSK of its rights hereunder.
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INFORMATION AND REPORTS DURING DEVELOPMENT AND COMMERCIALIZATION. Ortho and GTx will disclose and make available to each other upon written request and without charge (other than reimbursement to the providing Party for reasonable duplicating, postage and related expenses) all pre-clinical, clinical, regulatory, commercial, marketing, promotion, pricing, sales and other Information, including copies of all preclinical and clinical reports, known by Ortho or GTx that directly concern Collaboration Compounds or Collaboration Products, as provided for in this Agreement. Each Party will use commercially reasonable and diligent efforts to disclose to the other Party all significant Information relating to Collaboration Compounds or Collaboration Products promptly after it is learned or its significance is appreciated. Ortho shall [ * ]. Without limitation of the foregoing, each Party shall supply to the other the Information required by the other Party and reasonably requested by it (either as a routine practice or as a specific request) for purposes of compliance with regulatory requirements relating to Collaboration Compounds or Collaboration Products.
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INFORMATION AND REPORTS DURING DEVELOPMENT AND COMMERCIALIZATION. CoTherix and Asahi will disclose and make available to each other [***] all CMC/Process Development reports and preclinical, clinical and regulatory information, including copies of all preclinical and clinical reports resulting from Preclinical Development and Clinical Development, known by (with a right to disclose) or developed by or for CoTherix (or its Affiliates or Sublicensees) or Asahi, directly concerning Active Drug Substance and each Product when and as such Information becomes available to it at any time during the term of this Agreement. Each Party shall own and maintain its own database of data accumulated from all CMC/Process Development of Active Drug Substance and each Product, preclinical trial data accumulated from all Preclinical Development of Active Drug Substance and each Product, clinical trial data accumulated from all Clinical Development of each Product and adverse drug reaction information for each Product. At the option of the requesting Party, such data shall be provided in a computer readable format by the providing Party, to the extent available. Asahi and its Affiliates shall use reasonable efforts to supply CoTherix with information and data regarding Development and Regulatory Approval of the other Fasudil Formulations not addressed by the foregoing to the extent necessary or useful for the Development or Regulatory Approval of Products by CoTherix hereunder. Without limiting the foregoing, each Party shall supply to the other the Information required by the other Party and requested by it (either as a routine practice or as a specific request) for purposes of compliance with direct regulatory requirements and, if requested by CoTherix, shall be provided to CoTherix in English. [***]. CoTherix shall not be under any obligation to translate for Asahi any Information provided by CoTherix.
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INFORMATION AND REPORTS DURING DEVELOPMENT AND COMMERCIALIZATION. Schering and Sonus will disclose and make available (subject to any confidentiality agreements or requirements of law) to each other without charge all preclinical, clinical, regulatory, marketing, pricing, sales and other Information including copies of all preclinical and clinical reports held by Schering or Sonus directly concerning the Product within the Field at any time during the Term of this Agreement. Each Party shall own and maintain its own database of clinical trial data accumulated from all clinical trials of the Product for which it was responsible, and of adverse drug event information for the Product. At the option of the requesting Party, such data shall be provided in a computer readable format by the providing Party to the extent available. Without limiting the foregoing, each Party shall supply to the other the Information required by the other Party and reasonably requested by it (either as a routine practice or as a specific request) for purposes of compliance with regulatory requirements. With respect to Information concerning Commercialization, Schering agrees to keep Sonus regularly informed on all such activities in accordance with the requirements of Article VI of this Agreement.
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INFORMATION AND REPORTS DURING DEVELOPMENT AND COMMERCIALIZATION. Ipsen and GTx will disclose and make available to each other upon written request and without charge (other than reimbursement to the providing Party for reasonable duplicating, postage and related expenses) all pre-clinical, clinical, quality, regulatory, commercial, marketing, promotion, pricing, sales and other Information, including copies of all preclinical and clinical reports, known by Ipsen or GTx that directly concern Licensed Product, as provided for in this Agreement. Each Party will use commercially reasonable efforts to disclose to the other Party all significant Information relating to Licensed Product promptly after it is learned or its significance is appreciated. GTx shall own and maintain the combined database of clinical trial data accumulated from all clinical trials of Licensed Product and of adverse drug event information for all Licensed Product. Without limitation of the foregoing, each Party shall supply to the other the Information required by the other Party and reasonably requested by it (either as a routine practice or as a specific request) for purposes of compliance with regulatory requirements relating to Licensed Product.
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INFORMATION AND REPORTS DURING DEVELOPMENT AND COMMERCIALIZATION. Schering and Titan will disclose and make available (subject to any confidentiality agreements or requirements of law) to each other without charge all preclinical, clinical, regulatory and other Information, including copies of all preclinical and clinical reports known by Schering or Titan directly concerning the Product within the Field at any time during the term of this Agreement. Each Party shall own and maintain its own database of clinical trial data accumulated from all clinical trials of the Product for which it was responsible and of adverse drug event information for the Product. At the option of the requesting Party, such data shall be provided in a computer readable or other electronic format by the providing Party, to the extent available, which shall also assist in the transfer and validation of such data to the receiving Party. Without limitation of the foregoing, each Party shall supply to the other the information required by the other Party and requested by it (either as a routine practice or as a specific request) for purposes of compliance with regulatory requirements. With respect to information concerning Commercialization, Schering agrees to keep Titan regularly informed on all post marketing activities but shall have no obligation, except as specifically set out in this Agreement, to share pricing, marketing or sales information with Titan.
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Related to INFORMATION AND REPORTS DURING DEVELOPMENT AND COMMERCIALIZATION

  • Commercialization Reports After the First Commercial Sale of a Licensed Product anywhere in the Territory, LICENSEE shall submit to Cornell semi-annual reports on or before each February 28 and August 31 of each year. Each report shall cover LICENSEE’s (and each Affiliate’s and Sublicensee’s) most recently completed calendar half-year and shall show:

  • 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).

  • Development Activities NovaDel shall not be required to commence any Development Activities until Licensee has paid at least twenty-five percent (25%) of the non-refundable License Fee described in Section 4.4.

  • 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.

  • Development of Products (a) During the term of this Agreement, ViewRay may from time to time seek services from PEKO with respect to the development of certain Products that can be incorporated into the ViewRay Renaissance™ MRI-guided radiation therapy system. For each Program to be undertaken by PEKO pursuant to this Agreement, the parties will prepare a “Work Statement” and agree to said “Work Statement” in substantially the form attached as Attachment 1. Each Work Statement will describe: (i) the (i) services that PEKO will be responsible for providing to ViewRay and the deliverables that PEKO will be responsible for delivering to ViewRay (“Deliverable(s)”), (ii) delivery schedule for the Deliverables, (iii) pricing terms, (iv) work plan for the Program, and (v) ViewRay’s responsibilities in connection with the Program. Each Work Statement will be prepared based upon the requirements and information provided to PEKO by ViewRay. A separate Work Statement will be required for each Program; and each Work Statement will become subject to this Agreement only when mutually agreed and signed by ViewRay and PEKO.

  • 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:

  • Commercialization Efforts The RECIPIENT shall, including whether through its own efforts or the efforts of a licensee under a License Agreement allowed by the terms of this Attachment, use diligent and commercially reasonable efforts to commercialize at least one Commercial Product or Commercial Service or otherwise bring to practical application the Project Results in accordance with the commercial development plan submitted with the Application and including any changes to such commercial development plan in accordance with Section D3.01. For the avoidance of doubt, partnering or licensing activities shall be considered to be efforts to commercialize.

  • 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.

  • Information Systems Acquisition Development and Maintenance a. Client Data – Client Data will only be used by State Street for the purposes specified in this Agreement.

  • Development Reports Beginning six months after Effective Date and ending on the date of first commercial sale of a Licensed Product in the United States, LICENSEE shall report to Cornell progress covering LICENSEE's (and Affiliate's and Sublicensee's) activities and efforts in the development of rights granted to LICENSEE under this Agreement for the preceding six months. The report shall include, but not be limited to, activities and efforts to develop and test all Licensed Products and obtain governmental approvals necessary for marketing the same. Such semi-annual reports shall be due within sixty days (60) of the reporting period and shall use the form as provided herein as Appendix C.

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