Development Event Sample Clauses

Development Event. The term “
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Development Event. (1) Not more than [*] and (2) an acceptable [*] Not more than [*] Media Release Basel, Switzerland and Fremont, CA 16 September, 2004 Roche and Protein Design Labs to jointly develop Zenapax for Asthma Roche and Protein Design Labs (PDL) (NASDAQ: PDLI) today announced a worldwide agreement to co-develop and commercialize Zenapax® (Daclizumab) for asthma and related respiratory diseases, based on recent positive phase II data in patients with moderate to severe asthma. ▇▇▇▇ ▇▇▇▇▇▇, Chief Executive Officer, PDL, said, “The continued development of daclizumab in asthma is among PDL’s highest clinical development priorities. With Roche as our ongoing partner in this indication, we believe daclizumab will obtain the resources needed to develop the full potential of this humanized antibody in asthma.” “This new agreement will strengthen our pipeline in asthma, where we are currently in phase II development of a novel oral treatment,” said ▇▇▇▇▇▇▇ ▇▇▇▇▇, Head of Roche’s Pharmaceuticals Division. “We believe that daclizumab will offer patients a significant improvement over today’s current therapy. Our long-standing relationship with PDL continues to grow as we develop daclizumab further.” Under terms of the agreement, PDL will receive a $17.5 million upfront payment as well as up to $187.5 million in development and commercialization milestones for successful further development of daclizumab. Roche and PDL will globally co-develop daclizumab in asthma, share development expenses and co-promote the product in the US. Outside the US, PDL will receive royalties on net sales of the product in asthma. In 1989, Roche acquired the worldwide rights to daclizumab, a product that has since gained an important position within Roche’s transplantation portfolio. In October 2003, Roche resold to PDL all rights to daclizumab, except in transplantation, until 2007 when PDL will have the option to re-acquire the transplantation rights as well. In 2004, PDL approached Roche with compelling phase II data for daclizumab in asthma, leading to today’s announcement for the continued co-development of daclizumab in respiratory disorders by Roche and PDL. Asthma is among the most common chronic medical conditions in the United States and worldwide, affecting more than 20 million people in the United States, according to the American Lung Association (ALA) and the American Academy of Allergy, Asthma & Immunology (AAAAI). According to a recent report on the global burden of asthma publish...
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Development Event. 12 1.33 Dollars ....................................................................................................................... 13 1.34
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Development Event. (1) Not more than [****] and (2) an acceptable [****] Not more than [****] **** Certain information on this page has been omitted and filed separately with the commission. Confidential treatment has been requested with respect to the omitted portions. EXHIBIT E Nutley, NJ and Fremont, CA Roche and Protein Design Labs, Inc. (PDL) (NASDAQ: PDLI) today announced an expansion to their partnership to co-develop and commercialize daclizumab for organ transplant patients on long-term, maintenance therapy. Roche currently markets daclizumab for induction transplant therapy as Zenapax®. Roche and PDL are developing a new subcutaneous daclizumab (daclizumab s.c.) formulation, manufactured by PDL, for use in Phase II clinical trials expected to start in 2006. Currently, transplant patients are treated with the combination therapy of Roche’s CellCept® (mycophenolate mofetil) with a calcineurin inhibitor such as cyclosporine and steroids to prevent organ rejection. However, the long-term use of the current calcineurin inhibitors can cause kidney toxicity, diabetes and cardiovascular disorders. Using daclizumab s.c. as maintenance treatment in combination with CellCept may allow for the reduction, and potential elimination, of the more toxic drugs from transplant patient maintenance regimens. ▇▇▇▇ ▇▇▇▇▇▇, Chief Executive Officer, PDL, said, “We are enthusiastic about the opportunity to develop daclizumab s.c. with our longstanding partner Roche. Today’s agreement builds upon our existing collaboration with Roche in asthma, as we continue to explore development of daclizumab s.c. in other indications.” “Roche and PDL are highly committed to daclizumab, our partnership, and in developing better treatments to improve long-term outcomes for transplant patients,” said ▇▇▇▇▇ ▇▇▇, ▇▇▇▇▇’▇ Global Head of Pharma Partnering. “With the potential to use CellCept® and daclizumab s.c. as the centerpiece for long-term transplant therapy, we could offer patients a safer, more tolerable option.” Roche and PDL have amended their current agreements to reflect the scope of daclizumab s.c.’s further development. Under the terms of this agreement, PDL will receive a $10 million upfront payment and may be eligible to receive payments up to $145 million if certain milestones are satisfied and if the indication is successfully developed. Roche will continue to manufacture and promote Zenapax® exclusively on a worldwide basis. Roche and PDL will share equally global development costs, and PDL ha...
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Development Event. 7 1.12. [**] ................................................................................................................ 7 1.13. Effective Date .............................................................................................. 7 1.14. FDA ............................................................................................................. 7 1.15. FDCA ........................................................................................................... 7 1.16. ICD-11 ......................................................................................................... 7 1.17. Initiation ....................................................................................................... 7 1.18. Know-How ................................................................................................... 7 1.19.
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Related to Development Event

  • Development Period The Contractor may commence pre-construction activities like utility shifting, boundary wall construction or any other activity assigned to the Contractor by the Authority to enable construction of the Project Highway immediately after signing of the Agreement, to the extent that such work is ready for execution. The Parties agree that these works may be taken up and completed to the extent feasible by the Contractor, before declaration of the Appointed Date, but no claim against the Authority for delay shall survive during this period and that the undertaking of these works by the Contractor shall not count towards the Scheduled Construction Period of the project which starts counting only from the Appointed Date. No construction activity of the Project Highway shall be undertaken during the development period.

  • Development Rights The Employee agrees and declares that all proprietary information including but not limited to trade secrets, know-how, patents and other rights in connection therewith developed by or with the contribution of Employee's efforts during his employment with the Company shall be the sole property of the Company. Upon the Company's request (whenever made), Employee shall execute and assign to the Company all the rights in the proprietary information.

  • Development Milestones In addition to its obligations under Paragraph 7.1, LICENSEE specifically commits to achieving (either itself or through the acts of a SUBLICENSEE) the following development milestones in its diligence activities under this AGREEMENT: (a) (b).

  • Development Milestone Payments TriSalus shall pay (or cause to be paid) to Dynavax, in accordance with and subject to the terms of this Section 2.3, Section 2.4 and Section 6.4 (each such milestone, a “Development Milestone”, and each payment in respect thereof, a “Development Milestone Payment”): (i) Upon the successful completion by a Milestone Obligor after the Closing of a [**] study with respect to a Product using PEDD, a payment of [**] US Dollars ($[**]), with such Development Milestone Payment being payable only once (for purposes of the foregoing, successful completion means completion of such study in accordance with the plan for such study); (ii) For the first patient Dosed by a Milestone Obligor in each Phase 1 Clinical Trial for a Product for each Indication, a payment of [**] US Dollars ($[**]), up to a maximum of [**] such payments, regardless of how many Indications are pursued for a Product or how many Products are in development by Milestone Obligor; (iii) For the first patient Dosed by a Milestone Obligor in each Phase 2 Clinical Trial for a Product for each Indication, a payment of [**] US Dollars ($[**]), up to a maximum of [**] such payments regardless of how many Indications are pursued for a Product or how many Products are in development by Milestone Obligor; (iv) For each Phase 2 Clinical Trial for a Product for each Indication conducted by or on behalf of a Milestone Obligor meeting the primary endpoint for such Phase 2 Clinical Trial based on full tables, figures and listings or continued development of such Product for the same Indication as such Phase 2 Clinical Trial, a payment of [**] US Dollars ($[**]), up to a maximum of [**] such payments, regardless of how many Indications are pursued for a Product or how many Products are in development by Milestone Obligor; (v) For each Phase 3 Clinical Trial for a Product for each Indication conducted by or on behalf of a Milestone Obligor meeting the primary endpoint for such Phase 3 Clinical Trial based on full tables, figures and listings or continued development of such Product for the same Indication as such Phase 3 Clinical Trial, a payment of [**] US Dollars ($[**]), up to a maximum of [**] such payments, regardless of how many Indications are pursued for a Product or how many Products are in development by Milestone Obligor; (vi) Upon receipt by a Milestone Obligor of each Regulatory Approval for any Product for any Indication in the U.S., a payment of [**] US Dollars ($[**]), up to a maximum of [**] such payments, regardless of how many Indications are pursued for a Product or how many Products achieve Regulatory Approval; (vii) Upon receipt by a Milestone Obligor for each Regulatory Approval of any Product for any Indication in any country or region outside the U.S., a payment of [**] US Dollars ($[**]), up to a maximum of [**] such payments, regardless of how many Indications are pursued for a Product or how many Products achieve Regulatory Approval; (viii) Upon receipt by a Milestone Obligor for each Regulatory Approval for a Product with Orphan Drug Exclusivity for each Indication of a Product in the U.S., a payment of [**] US Dollars ($[**]), up to a maximum of [**] such payments (which, for clarity, shall be payable in addition to the Development Milestone payable under Section 2.3(a)(vi) for receipt of such Regulatory Approval), regardless of how many Indications are pursued for a Product or how many Products achieve Regulatory Approval; and (ix) Upon receipt by a Milestone Obligor for each Regulatory Approval for a Product with Orphan Drug Exclusivity for each Indication of a Product in any country or region outside the U.S., a payment of [**] US Dollars ($[**]), up to a maximum of [**] such payments (which, for clarity, shall be payable in addition to the Development Milestone payable under Section 2.3(a)(vii) for receipt of such Regulatory Approval), regardless ​ of how many Indications are pursued for a Product or how many Products achieve Regulatory Approval.

  • Development Phase contractual phase initiated with the approval of ANP for the Development Plan and which is extended during the Production Phase while investments in ▇▇▇▇▇, equipment, and facilities for the Production of Oil and Gas according to the Best Practices of the Oil Industry are required.