Development. (a) Resonant and Skyworks shall each diligently perform the actions and tasks assigned to them respectively, and substantially on the schedule set forth on Exhibit A attached hereto. The schedule will commence on the earlier of October 1, 2013 or as soon as practicable following the closing of Resonant’s private financing. If Resonant and Skyworks mutually agree, they may execute Statements of Work (each an “SOW”) to further supplement Exhibit A, including to describe (i) contributions of Proprietary Technology and other resources by each of Skyworks and Resonant; (ii) adjustments to the anticipated timing for completion of each milestone set forth on Exhibit A (each, a “Milestone”); (iii) adjustments to specifications and/or acceptance criteria for the Duplexer to be developed in connection with such Milestone; (iv) additional Milestones; and (v) any adjustments to funding commitments related to the Development Project set forth on Exhibit B. However, no such additional SOW is required or a condition to the obligations in this Agreement or as a condition to commencement of the Development Project, unless agreed mutually in an SOW. If an SOW is entered, each such SOW shall automatically be deemed attached to this Agreement as a supplement to Exhibit A upon execution thereof by Skyworks and Resonant without additional action required. Any such mutually executed SOW shall govern such aspects of the development process as specified therein and shall, to the extent stated expressly therein, supersede and replace specified terms of Exhibit A. Any amendments or revisions to any SOW that may be entered shall be mutually agreed to by the parties to the SOW in writing. (b) Each of the parties agrees to be responsible for its own costs relating to its negotiation of and performance under this Agreement, except as may be expressly set forth in a mutually agreed to SOW. (c) Within five (5) days following execution of this Agreement, Resonant and Skyworks shall each identify no less than two (2) representatives who will be dedicated to the Development Project (the “Development Team”). Personnel comprising the Development Team shall have the requisite knowledge and expertise necessary to carry out the respective obligations of the parties on Exhibit A and be reasonably familiar with the technology to be used in connection therewith. Any party can change its members of the Development Team upon written notice to the other party so long as such new personnel meet the requirements of this sub-paragraph 2(c).
Appears in 2 contracts
Sources: Development Agreement (Resonant Inc), Development Agreement (Resonant Inc)
Development. (a) Resonant and Skyworks shall each diligently perform the actions and tasks assigned Prior to them respectively, and substantially on the schedule set forth on Exhibit A attached hereto. The schedule will commence on the earlier of October 1, 2013 or as soon as practicable following the closing of Resonant’s private financing. If Resonant and Skyworks mutually agree, they may execute Statements of Work (each an “SOW”) to further supplement Exhibit A, including to describe (i) contributions Titan’s receipt of Proprietary Technology and other resources by each of Skyworks and Resonant; a complete response letter from the FDA or (ii) adjustments the NDA Transfer Date, Titan will be solely responsible for all costs associated with, or required for the approval of, the Product by the FDA in the Territory. After such date, subject to Section 12.2(c)(ii), Braeburn will be solely responsible for all costs associated with, or required for the approval of, the Product by the FDA in the Territory. With respect to approval of the Product by Regulatory Authorities in the Territory other than the FDA, commencing on the Effective Date, Braeburn will be solely responsible for all costs associated with, or required for the approval of, the Product. While the Parties may choose, at their sole discretion, to work together on particular projects, except as otherwise provided in this Agreement, the Parties will operate independently in their activities for their respective development of Product in the Territory and the Titan Territory, as applicable, but will provide access to certain information to the anticipated timing for completion Development Committee and to each other as expressly described in this Agreement. From and after the NDA Transfer Date, Braeburn shall provide the Development Committee with (i) a written semiannual report summarizing in reasonable detail Braeburn’s activities and progress related to the development of each milestone set forth on Exhibit A (eachthe Product in the Territory, a “Milestone”); (iii) adjustments to specifications and/or acceptance criteria for including conduct of Phase IV Trials and clinical trials in Subsequent Indications and, after the Duplexer NDA Transfer Date, information regarding the status of Regulatory Documents submitted and intended to be developed submitted to Regulatory Authorities and Regulatory Approvals, and (ii) a copy of the annual report submitted to the FDA in connection with such Milestone; (iv) additional Milestones; and (v) any adjustments to funding commitments related to the Development Project set forth on Exhibit B. Howeverperiodic reporting requirement for the IND. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, no such additional SOW is required or a condition to the obligations in this Agreement or as a condition to commencement of the Development Project, unless agreed mutually in an SOW. If an SOW is entered, each such SOW shall automatically be deemed attached to this Agreement as a supplement to Exhibit A upon execution thereof by Skyworks and Resonant without additional action required. Any such mutually executed SOW shall govern such aspects of the development process as specified therein and shall, to the extent stated expressly therein, supersede and replace specified terms of Exhibit A. Any amendments or revisions to any SOW that may be entered shall be mutually agreed to by the parties to the SOW in writingAS AMENDED.
(b) Each Notwithstanding the foregoing Section 4.1 (a),
(i) prior to the NDA Transfer Date, Titan shall take all actions reasonably necessary and appropriate to obtain FDA Approval for the Initial Indication, including preparing and submitting the Product NDA; and
(ii) to the extent reasonably requested from time to time by Braeburn and agreed to by Titan (such agreement not to be unreasonably withheld, subject to the continued availability of the parties agrees personnel, subcontractors, and technology used by Titan as of the Effective Date to provide similar services), Titan shall reasonably assist Braeburn, its Affiliates and sublicensees in development activities with respect to the Product, including (A) assisting in preparing and filing of INDs with respect to Subsequent Indications, (B) assisting in designing and executing all Phase IV Clinical Trials or other pre-clinical or clinical trials for the Product, and (C) assisting in preparing and submitting for approval of the Product by any Regulatory Authority in the Territory other than the FDA. Notwithstanding the foregoing, Titan shall not be responsible required to hire additional personnel, engage additional Third Party providers or procure additional technology to provide any such development activities or services. Braeburn shall pay Titan service fees for its own costs relating the performance of all such development services and activities contemplated by clause (ii) of this Section 4.1(b), as well as any other development services and activities performed by Titan at Braeburn’s request, in an amount equal to its negotiation Titan’s Fully Burdened Cost of providing such services and performance under this Agreementactivities, except as may be expressly set forth in a mutually agreed to SOW.
within thirty (c) Within five (530) days following execution of this Agreement, Resonant after Titan’s invoice is provided to Braeburn for the associated development services and Skyworks shall each identify no less than two (2) representatives who will be dedicated to the Development Project (the “Development Team”). Personnel comprising the Development Team shall have the requisite knowledge and expertise necessary to carry out the respective obligations of the parties on Exhibit A and be reasonably familiar with the technology to be used in connection therewith. Any party can change its members of the Development Team upon written notice to the other party so long as such new personnel meet the requirements of this sub-paragraph 2(c)activities.
Appears in 2 contracts
Sources: License Agreement (Braeburn Pharmaceuticals, Inc.), License Agreement (Braeburn Pharmaceuticals, Inc.)
Development. 4.1.1. LICENSEE shall itself, or through its Affiliates or sublicensees, use Commercially Reasonable Efforts to Develop the Product in the Territory, and LICENSEE shall undertake all Development activities at its sole expense. Without limiting the foregoing, in connection with its efforts to Develop the Product, LICENSEE shall bear all responsibility and expense for filing Regulatory Filings in LICENSEE’s name and obtaining Regulatory Approval for the Product. LICENSEE’s Development activities will be undertaken in accordance with a Development plan (the “Development Plan”), the initial Development Plan being attached to the Agreement as Schedule D (the “Initial Development Plan”). PFIZER acknowledges that (a) Resonant and Skyworks shall each diligently perform the actions and tasks assigned to them respectively, and substantially Initial Development Plan has been based on the schedule set forth on Exhibit A attached hereto. The schedule will commence on due diligence carried out by LICENSEE prior to the earlier of October 1Effective Date, 2013 or as soon as practicable following the closing of Resonant’s private financing. If Resonant and Skyworks mutually agree, they may execute Statements of Work (each an “SOW”) largely utilizing information furnished to further supplement Exhibit A, including to describe (i) contributions of Proprietary Technology and other resources LICENSEE by each of Skyworks and ResonantPFIZER; (iib) adjustments to the anticipated timing for completion of each milestone set forth such Plan is predicated, in part, on Exhibit A (each, a “Milestone”); (iii) adjustments to specifications and/or acceptance criteria for the Duplexer to be developed in connection with such Milestone; (iv) additional Milestonesclinical data that has not yet been generated; and (vc) any such Plan is subject to revision from time to time to take into account, among other factors: safety or efficacy concerns, matters related to Patent coverage, or issues related to present or future marketability or profitability, including existing or anticipated competition, and that such revisions may include seeking regulatory approval for different indications than are contained in the Initial Development Plan. Each Development Plan or amendment shall be treated by both Parties as a good faith statement of LICENSEE’s intentions for the Development of the Product, but such Development Plan shall not be deemed to be a contractual commitment by LICENSEE to undertake all of the efforts described in such Plan or to refrain from making adjustments to funding commitments related such Plan that, in LICENSEE’s reasonable judgment, are necessary in light of factors described in the preceding sentence. LICENSEE shall provide to PFIZER reports regarding LICENSEE’s progress and future plans, including amendments to the Development Project set forth on Exhibit B. HoweverPlan, no such additional SOW is required or a condition to every six (6) months during the obligations in this Agreement or as a condition to commencement of the Development Project, unless agreed mutually in an SOW. If an SOW is entered, each such SOW shall automatically be deemed attached to this Agreement as a supplement to Exhibit A upon execution thereof by Skyworks and Resonant without additional action required. Any such mutually executed SOW shall govern such aspects of the development process as specified therein and shall, to the extent stated expressly therein, supersede and replace specified terms of Exhibit A. Any amendments or revisions to any SOW that may be entered shall be mutually agreed to by the parties to the SOW in writing.
(b) Each of the parties agrees to be responsible for its own costs relating to its negotiation of and performance under this Agreement, except as may be expressly set forth in a mutually agreed to SOW.
(c) Within five (5) days following execution of this Agreement, Resonant and Skyworks shall each identify no less than two (2) representatives who Pfizer will be dedicated provided with an opportunity to comment on all amendments to the Development Project (Plan as well as all Development and Commercialization activities.
4.1.2. Notwithstanding the “Development Team”). Personnel comprising the Development Team shall have the requisite knowledge and expertise necessary to carry out the respective obligations provisions of the parties on Exhibit A foregoing Section 4.1.1, LICENSEE shall, at a minimum, complete the PFIZER 1014 Study as well as initiating and be reasonably familiar with completing the technology to be used Phase I Monotherapy Study as described in connection therewith. Any party can change its members Schedule D. The initiation of the Development Team upon written notice to Phase I Monotherapy Study will occur no later than by the other party so long as such new personnel meet end of the requirements first quarter of this sub-paragraph 2(c)2012.
Appears in 2 contracts
Sources: License Agreement (Clovis Oncology, Inc.), License Agreement (Clovis Oncology, Inc.)
Development. Section 4.01. Joint Development in the Field in the Territory.
(a) Resonant and Skyworks shall each diligently perform Within [***] ([***]) days after the actions and tasks assigned Effective Date, the Parties will, through the JDC, prepare both a reasonably detailed written plan related to them respectively, and substantially on preclinical Development of Licensed Products in the schedule set forth on Exhibit A attached hereto. The schedule will commence on Territory (the earlier of October 1, 2013 or as soon as practicable following the closing of Resonant’s private financing. If Resonant and Skyworks mutually agree, they may execute Statements of Work (each an “SOWPreclinical Development Plan”) to further supplement Exhibit A, including to describe (i) contributions of Proprietary Technology and other resources by each of Skyworks and Resonant; (ii) adjustments to the anticipated timing for completion of each milestone set forth on Exhibit A (each, a “Milestone”); (iii) adjustments to specifications and/or acceptance criteria for the Duplexer to be developed in connection with such Milestone; (iv) additional Milestones; and (v) any adjustments to funding commitments reasonably detailed written plan related to the Development Project of Licensed Products in the Territory, including Joint Studies to be conducted in the Territory (the “Clinical Development Plan”) (together the “Development Plans”). Each such plan shall include a reasonably detailed budget that sets forth the anticipated costs in connection therewith, including the Joint Study Costs. The JDC shall present the Preclinical Development Plan and the Clinical Development Plan to the JSC for review and approval, subject to (i) each Party’s final decision-making authority over Territory Exclusive Development Activities in its portion of the Territory as set forth in Section 3.11(a)(i) (Final Decision-Making Authority) and Section 3.11(b)(i) (Final Decision-Making Authority) and (ii) Astellas’ final decision-making authority regarding [***] as set forth in Section 3.11(b)(iii) (Final Decision-Making Authority), and (iii) the limitations thereon set forth in Section 3.12 (Limitations on Exhibit B. However, no such additional SOW is required or a condition to Decision-Making). All Development of Licensed Products in the obligations Field in this Agreement or as a condition to commencement of the Territory shall be governed by the Development ProjectPlans. The Clinical Development Plan shall provide for each Joint Study to be conducted in the Territory, and shall at least contain the Development activities set forth in the Initial Development Outline, unless agreed mutually otherwise approved by both Parties in an SOW. If an SOW is entered, each such SOW shall automatically be deemed attached to this Agreement as a supplement to Exhibit A upon execution thereof by Skyworks and Resonant without additional action required. Any such mutually executed SOW shall govern such aspects of the development process as specified therein and shall, to the extent stated expressly therein, supersede and replace specified terms of Exhibit A. Any amendments or revisions to any SOW that may be entered shall be mutually agreed to by the parties to the SOW advance in writing.
(b) . Each of the parties agrees Preclinical Development Plan and the Clinical Development Plan shall include anticipated timelines, budget, strategy and the respective roles and responsibilities of each Party with respect to be responsible for its own costs relating joint Development efforts in the Territory. The JDC shall periodically review the [***] Certain information in this document has been excluded pursuant to its negotiation of Regulation S-K, Item 601(b)(10). Such excluded information is not material and performance under this Agreement, except as may be expressly set forth in a mutually agreed to SOW.
(c) Within five (5) days following execution of this Agreement, Resonant and Skyworks shall each identify no less than two (2) representatives who will be dedicated would likely cause competitive harm to the Development Project (the “Development Team”). Personnel comprising the Development Team shall have the requisite knowledge and expertise necessary to carry out the respective obligations of the parties on Exhibit A and be reasonably familiar with the technology to be used in connection therewith. Any party can change its members of the Development Team upon written notice to the other party so long as such new personnel meet the requirements of this sub-paragraph 2(c)registrant if publicly disclosed.
Appears in 1 contract
Sources: License and Collaboration Agreement (Frequency Therapeutics, Inc.)
Development. (a) Resonant KISSEI will have the exclusive right and Skyworks shall each diligently perform obligation to develop and sell Promising Compounds in the actions and tasks assigned to them respectively, and substantially on the schedule set forth on Exhibit A attached hereto. The schedule will commence on the earlier of October 1, 2013 or as soon as practicable following the closing of Resonant’s private financing. If Resonant and Skyworks mutually agree, they may execute Statements of Work (each an “SOW”) to further supplement Exhibit AExclusive Territory, including without limitation the obligation to describe (i) contributions initiate and complete any preclinical and clinical studies required to obtain regulatory approval of Proprietary Technology Promising Compounds in the Exclusive Territory and other resources by each of Skyworks and Resonant; (ii) adjustments to the anticipated timing for completion of each milestone set forth on Exhibit A (each, a “Milestone”); (iii) adjustments to specifications and/or acceptance criteria for the Duplexer to be developed in connection with such Milestone; (iv) additional Milestones; and (v) any adjustments to funding commitments related to the Development Project set forth on Exhibit B. However, no such additional SOW is required or a condition to the obligations in this Agreement or as a condition to commencement shall bear all costs of the Development Project, unless agreed mutually Program for Promising Compounds in an SOW. If an SOW is entered, each such SOW shall automatically be deemed attached to this Agreement as a supplement to Exhibit A upon execution thereof by Skyworks and Resonant without additional action required. Any such mutually executed SOW shall govern such aspects of the development process as specified therein and shall, to the extent stated expressly therein, supersede and replace specified terms of Exhibit A. Any amendments or revisions to any SOW that may be entered shall be mutually agreed to by the parties to the SOW in writingExclusive Territory.
(b) Each KISSEI will have exclusive rights to develop, manufacture and sell Promising Compounds in the Semi-Exclusive Territory, but subject to the right of VERTEX, or not more than one licensee of VERTEX in any country in the Semi-Exclusive Territory, also to develop, manufacture or sell Promising Compounds in the Semi-Exclusive Territory. The parties agrees will seek to be responsible coordinate their respective development activities in the Semi-Exclusive Territory under a mutually agreeable co-development arrangement. Except as otherwise stated in a mutually agreeable co-development agreement, each party will bear the cost of its own development activities in the Semi-Exclusive Territory, except as set forth below with respect to Core Development Activities, and will have the right to market and sell in the Semi-Exclusive Territory, for its own costs relating to its negotiation of and performance under this Agreementaccount, except as may be expressly set forth in a mutually agreed to SOWproducts incorporating Promising Compounds.
(c) Within five (5) days following execution of this Agreement, Resonant and Skyworks shall each identify no less than two (2) representatives who VERTEX will be dedicated undertaking development activities, including preclinical and clinical studies and process research, necessary for the development of Promising Compounds outside the Territory. Prior to the Development Project (the “Development Team”). Personnel comprising commencement of the Development Team shall have Program with respect to a Promising Compound, VERTEX and KISSEI will meet to discuss the requisite knowledge worldwide development plan with respect to that Promising Compound, and expertise necessary will attempt to carry out the respective obligations identify those development activities being undertaken for development of the parties on Exhibit A Promising Compound outside the Territory (including preclinical and clinical studies and process research and development) which will be reasonably familiar necessary or useful for the registration of products incorporating that Promising Compound in Japan. Any such agreed activities are hereinafter referred to as "Core Development Activities." VERTEX expects those activities will be undertaken applying standards (which KISSEI will specifically note to VERTEX if in variance with usual and customary development practices and standards in the technology United States) which will allow the results of those activities to be used by KISSEI in its regulatory filings in Japan. VERTEX will provide KISSEI with any and all preclinical and clinical data generated by VERTEX from Core Development Activities in North America and Europe, and KISSEI shall be free to use such data and information solely for the purpose of developing Promising Compound(s) in the Territory pursuant hereto. If KISSEI should undertake Core Development Activities with the agreement of VERTEX, VERTEX shall be free to use any data and information generated by KISSEI in connection therewiththerewith solely for the purpose of developing Promising Compounds outside the Exclusive Territory. Any party can change its members of the KISSEI shall pay [ * ] Core Development Team upon written notice to the other party so long as such new personnel meet the requirements of this sub-paragraph 2(c)Activities.
Appears in 1 contract
Sources: Research and Development Agreement (Vertex Pharmaceuticals Inc / Ma)
Development. Relief will be responsible, at its own expense, for conducting Development in the Relief Territory and as set forth in this Section 3.2.
(a) Resonant and Skyworks shall each diligently perform the actions and tasks assigned to them respectively, and substantially on the schedule set forth on Exhibit A attached hereto. The schedule will commence on the earlier of October 1, 2013 or as soon as practicable following the closing of Resonant’s private financing. If Resonant and Skyworks mutually agree, they may execute Statements of Work (each an “SOW”) to further supplement Exhibit A, including to describe (i) contributions of Proprietary Technology and other resources by each of Skyworks and Resonant; (ii) adjustments Subject to the anticipated timing occurrence and continuation of Product’s Commercial Viability throughout the term of this Agreement, Relief will exercise Commercially Reasonable Efforts for completion of each milestone set forth on Exhibit A (eachDevelopment in the Relief Territory. In furtherance thereof, a “Milestone”); (iii) adjustments Relief will be deemed to specifications and/or acceptance criteria have exercised Commercially Reasonable Efforts for Development in the Relief Territory if it files an MAA for Regulatory Approval for the Duplexer to Product in the EU within three (3) years from the first positive assessment of Commercial Viability. Commercial Viability will be developed in connection with such Milestone; (iv) additional Milestones; and (v) any adjustments to funding commitments related to assessed every 6 months after the Development Project set forth on Exhibit B. However, no such additional SOW is required or a condition to Effective Date while Relief maintains the obligations in License granted under this Agreement or as a condition to commencement of the Development Project, unless agreed mutually in an SOW. If an SOW is entered, each such SOW shall automatically be deemed attached to this Agreement as a supplement to Exhibit A upon execution thereof by Skyworks and Resonant without additional action required. Any such mutually executed SOW shall govern such aspects of the development process as specified therein and shall, to the extent stated expressly therein, supersede and replace specified terms of Exhibit A. Any amendments or revisions to any SOW that may be entered shall be mutually agreed to by the parties to the SOW in writingAgreement.
(b) Each of Acer will provide Relief with reasonable assistance for Regulatory Approvals in the parties agrees Relief Territory. The activities to be responsible performed by Acer pursuant to this Section 3.2 shall be subject to the following: (i) Acer shall transfer any available, or easily available, documentation data or information free of charge; (ii) in case of Relief’s request of other documentation, data, information or support, Relief shall reimburse to Acer the Acer’s reasonable FTE Costs required for its own costs relating to its negotiation of and performance under this Agreementsuch purpose, except as may that such activities shall be expressly set forth performed by Acer free of charge to Relief to the extent that the activities are related to, or concern the, UCDs; (iii) Relief shall refund to Acer all the reasonable out-of-pocket expenses borne by Acer and agreed in a mutually agreed advance. For the sake of clarity, Acer shall not charge to SOWRelief the fees related to activities performed by Third Parties which could have been reasonable performed by Acer’s FTEs.
(c) Within five Relief will not take action in respect of Development in the Relief Territory that would reasonably be expected to materially adversely impact the ability of Acer to obtain Regulatory Approval (5) days following execution of this Agreement, Resonant and Skyworks shall each identify no less than two (2) representatives who will be dedicated in addition to the FDA Regulatory Approval of December 22, 2022) or to Commercialize outside the Relief Territory.
(d) At Relief’s expense, Acer will supply the Product to Relief for Development Project in the Relief Territory at Acer’s Cost of Goods according to a certain Clinical Supply Agreement and a certain Quality Technical Agreement (together, the “Clinical Supply and Quality Agreements”) based on Acer’s agreements with Third Party CDMCs for the manufacture and supply of Product, also executed between the Parties as of the Signing Date.
(e) Upon Relief’s request and, in any case, in the JSC meetings, Acer shall keep Relief informed about its Development Team”)strategy for the Product in any indication in the countries outside the Relief Territory. Personnel comprising the Development Team The Parties agree that Relief shall have the requisite knowledge right to request any change to Acer’s Development strategy which is reasonably required in order to support Relief’s Development in the Relief Territory. Acer shall consider in good faith and, if mutually agreed with Relief, implement such change, provided that (i) Relief shall pay any costs required by such change and expertise necessary to carry out (ii) the respective obligations of the parties on Exhibit A and be reasonably familiar with the technology to be used in connection therewith. Any party can change its members of does not unreasonably affect or delay the Development Team upon written notice strategy or timeline set by Acer in its territories. For avoidance of doubt, Acer will not take action in respect of Development in the Acer Territory that would reasonably be expected to materially adversely impact the other party so long as such new personnel meet ability of Relief to obtain Regulatory Approval or to Commercialize in the requirements of this sub-paragraph 2(c)Relief Territory.
Appears in 1 contract
Sources: Exclusive License Agreement (Relief Therapeutics Holding SA)
Development. (a) Resonant On a Product-by-Product basis, the applicable Licensee shall be solely responsible for the Development of the Product in the Field in the Territory, at Licensee’s own cost and Skyworks shall each diligently perform the actions and tasks assigned to them respectively, and substantially on the schedule expense (except as set forth on Exhibit A attached hereto. The schedule will commence on the earlier of October 1, 2013 or as soon as practicable following the closing of Resonant’s private financing. If Resonant and Skyworks mutually agree, they may execute Statements of Work (each an “SOW”in Section 4.3(b) to further supplement Exhibit Abelow), including to describe (i) contributions performance of Proprietary Technology and other resources by each of Skyworks and Resonant; (ii) adjustments to the anticipated timing for completion of each milestone set forth on Exhibit A (each, a “Milestone”); (iii) adjustments to specifications and/or acceptance criteria all clinical trials for the Duplexer Product in the Field in the Territory necessary to be developed obtain Regulatory Approval for the Product in connection with such Milestone; (iv) additional Milestones; and (v) any adjustments to funding commitments related to the Development Project set forth on Exhibit B. However, no such additional SOW is required or a condition to Field in the obligations in this Agreement or as a condition to commencement of the Development Project, unless agreed mutually in an SOW. If an SOW is entered, each such SOW shall automatically be deemed attached to this Agreement as a supplement to Exhibit A upon execution thereof by Skyworks and Resonant without additional action required. Any such mutually executed SOW shall govern such aspects of the development process as specified therein and shall, to the extent stated expressly therein, supersede and replace specified terms of Exhibit A. Any amendments or revisions to any SOW that may be entered shall be mutually agreed to by the parties to the SOW in writingTerritory.
(b) Each On a Product-by-Product basis, the applicable Licensor shall have the option to share [***] of the parties agrees to be responsible Development cost (both internal and out-of-pocket cost) for its own costs relating to its negotiation the Product through completion of and performance under this Agreement, except the first Phase I Clinical Trial in exchange of increased Sublicense Revenue sharing as may be expressly set forth in Section 5.5; provided that such cost sharing obligation shall be only with respect to reasonable, typical costs for similar products at similar stages of development. The Licensor may exercise such option by written notice to Licensee within [***] after the applicable ADC is selected by the Licensee for further Development. If Licensor timely exercises such option, then (i) at the beginning of each calendar quarter through completion of the first Phase 1 Clinical Trial, Licensee shall provide Licensor with a reasonably detailed Development plan and budget for review and discussion; (ii) within [***] after the end of each calendar quarter through completion of the first Phase 1 Clinical Trial, Licensee shall provide Licensor with a reasonably detailed report setting forth the internal and out-of-pocket cost incurred during the Development of the Product during such calendar quarter; and (iii) within [***] after the receipt of such report, Licensor shall pay to Licensee [***] of such cost so that the Parties share such cost equally. If Licensor in good faith disputes any portion of the Development cost reported by Licensee, such dispute shall be resolved by an independent auditor mutually agreed to SOW.
(c) Within five (5) days following execution of this Agreement, Resonant and Skyworks shall each identify no less than two (2) representatives who will be dedicated to by the Development Project (the “Development Team”)Parties. Personnel comprising the Development Team Such auditor shall have the requisite knowledge right to inspect and expertise necessary audit the records of Licensee related to carry out such Development cost, and shall report his/her determination to the respective obligations Parties. Such auditor’s determination shall be final and binding on the Parties, and the Party to whom such auditor rules against shall pay for the fees of such auditor. Any payment attributable to such disputed portion shall only be after such dispute is resolved and any adjustment has been made by the Parties based on the determination of the parties on Exhibit A and be reasonably familiar with the technology to be used in connection therewith. Any party can change its members of the Development Team upon written notice to the other party so long as such new personnel meet the requirements of this sub-paragraph 2(c)auditor.
Appears in 1 contract
Sources: Collaboration and License Agreement (Immunome Inc.)
Development. Tenant and those claiming under it may perform any lawful Construction on the Premises without the consent of Landlord. Without limiting the foregoing, the Concept Plan is a conceptual plan for the Premises and includes presently proposed phases, presently anticipated time frames for development, and the presently proposed uses of the Project. Tenant and Landlord recognize and agree that except for the Park Property, the location and boundaries of which shall not be changed without the prior written consent of Landlord, the Development plan for the Premises will change over time based on market conditions and needs, and that Tenant requires the flexibility to react to those changing conditions in a prompt and timely fashion. Thus, this Concept Plan should be considered a general guideline for the Development of the Premises, which Tenant may modify from time to time in its sole discretion, except as provided above as to the Park Property. Likewise, the projected time frames and sequence of Development is totally market driven and, therefore, such time frames and sequencing are merely aspirational goals and may be changed from time to time by Tenant in its sole discretion. However, notwithstanding anything to the contrary in this Lease, Tenant shall cause the timely completion of (a) Resonant and Skyworks shall each diligently perform the actions and tasks assigned to them respectivelyInitial Development, (b) the Second Stage Development, and substantially on (c) the Third Stage Development, in each case subject to extension by reason of Unavoidable Delay (collectively, “Tenant’s Construction Obligations”), and no change in the Concept Plan shall be deemed to change the requirements included in Tenant’s Construction Obligations. Notwithstanding anything to the contrary in this Lease, any breach of Tenant’s Construction Obligations as set forth in the immediately preceding subsections (a) and (b) shall become an Event of Default if not cured within ninety (90) days of Notice from Landlord of same. A projected schedule of values and projected timeline for the Initial Development is set forth on Exhibit A D-1 attached hereto. The schedule will commence All Construction at the Premises shall be performed in a good and workmanlike manner. Tenant shall Notify Landlord of all material changes to the Concept Plan. Tenant shall not be in default of the requirements regarding good and workmanlike construction and required notification of changes in the Concept Plan until it has received a Minor Default Notice which includes, in all capital and bold letters, in a size no smaller than the largest print on the earlier Minor Default Notice , the following legend: "FAILURE TO TIMELY TAKE ACTION MAY RESULT IN ENFORCEMENT ACTION” and the opportunity to cure that is afforded Tenant in the definition of October 1Delay Fee under this Lease, 2013 or as soon as practicable following the closing and thereafter Landlord's sole remedies for breach of Resonant’s private financing. If Resonant and Skyworks mutually agree, they may execute Statements of Work (each an “SOW”) this obligation shall be limited to further supplement Exhibit A, including to describe (i) contributions of Proprietary Technology and other resources by each of Skyworks and Resonant; (ii) adjustments to the anticipated timing for completion of each milestone set forth on Exhibit A (each, a “Milestone”); (iii) adjustments to specifications specific performance and/or acceptance criteria for the Duplexer to be developed in connection with such Milestone; (iv) additional Milestones; and (v) any adjustments to funding commitments related to the Development Project set forth on Exhibit B. However, no such additional SOW is required or a condition to the obligations in this Agreement or as a condition to commencement payment of the Development ProjectDelay Fee, unless agreed mutually and Tenant waives all defenses, except defense of performance, in an SOWany action brought by Landlord to enforce its rights under this Section. If an SOW is entered, each such SOW The foregoing shall automatically not be deemed attached to this Agreement as a supplement limit in any way the regulatory requirements, Approvals or processes required by Law for Construction. Tenant agrees to Exhibit A upon execution thereof by Skyworks seek any necessary Approvals from Landlord, acting in its governmental capacity, and Resonant without additional action required. Any agrees that such mutually executed SOW shall govern such aspects of the development process as specified therein and shall, to the extent stated expressly therein, supersede and replace specified terms of Exhibit A. Any amendments or revisions to any SOW that may be entered Applications shall be mutually agreed to by the parties to the SOW in writing.
(b) Each of the parties agrees to be responsible for its own costs relating to its negotiation of and performance under this Agreement, except as may be expressly set forth in a mutually agreed to SOW.
(c) Within five (5) days following execution of this Agreement, Resonant and Skyworks shall each identify no less than two (2) representatives who will be dedicated to the Development Project (the “Development Team”). Personnel comprising the Development Team shall have the requisite knowledge and expertise necessary to carry out the respective obligations of the parties on Exhibit A and be reasonably familiar consistent with the technology to be used in connection therewith. Any party can change its members of the Development Team upon written notice to the other party so long Concept Plan, as such new personnel meet the requirements of this sub-paragraph 2(c)amended.
Appears in 1 contract
Sources: Lease Agreement
Development. (a) Resonant and Skyworks Company, alone and/or through its Affiliates and/or Sublicensees, shall each diligently perform use Commercially Reasonable Efforts to Develop a Product for approval in the actions and tasks assigned to them respectivelyUnited States, and substantially on each of the schedule Major European Countries. The Parties acknowledge that Company, alone and/or through its Affiliates and/or Sublicensees, may Develop Products that are a Combination Product. Without limiting the generality of the foregoing, Company, alone and/or through its Affiliates and/or Sublicensees, shall use Commercially Reasonable Efforts to execute and perform, or cause to be performed, the Development Plan, in accordance with the timelines set forth on Exhibit A attached hereto. The schedule will commence on the earlier of October 1therein, 2013 or as soon as practicable following the closing of Resonant’s private financing. If Resonant and Skyworks mutually agree, they may execute Statements of Work (each an “SOW”) to further supplement Exhibit ACompany shall conduct its Development activities in good scientific manner and in compliance with applicable Law, including to describe (i) contributions of Proprietary Technology Laws regarding environmental, safety and other resources by each of Skyworks and Resonant; (ii) adjustments to the anticipated timing for completion of each milestone set forth on Exhibit A (eachindustrial hygiene, a “Milestone”); (iii) adjustments to specifications and/or acceptance criteria for the Duplexer to be developed in connection with such Milestone; (iv) additional Milestones; and (v) any adjustments to funding commitments related to the Development Project set forth on Exhibit B. However, no such additional SOW is required or a condition to the obligations in this Agreement or as a condition to commencement of the Development Project, unless agreed mutually in an SOW. If an SOW is entered, each such SOW shall automatically be deemed attached to this Agreement as a supplement to Exhibit A upon execution thereof by Skyworks and Resonant without additional action required. Any such mutually executed SOW shall govern such aspects of the development process as specified therein and shalland, to the extent stated expressly thereinapplicable, supersede Good Laboratory Practice, Good Clinical Practice, current standards for pharmacovigilance practice, and replace specified terms all applicable requirements relating to the protection of Exhibit A. Any amendments or revisions human subjects. Company, alone and/or through its Affiliates and/or Sublicensees, shall have the right to engage Third Party subcontractors (including Distributors) to conduct any SOW of its Development, Manufacturing and Commercialization obligations under this Agreement; provided that may be entered (a) Company shall be mutually agreed liable hereunder for all actions or inactions of any of such Person, and (b) each such Person shall execute a non-disclosure/nonuse agreement no less restrictive than the terms and conditions contained in Article VII if Teva Confidential Information is to by the parties to the SOW in writingbe disclosed.
(b) Each of the parties agrees Company shall use Commercially Reasonable Efforts to be responsible for its own costs conduct all Development activities relating to its negotiation the Products in accordance with the Development Plan. Company shall have the right to amend the Development Plan from time to time; provided that no such Development Plan amendment may reduce or otherwise lessen the general diligence (except that the timelines for achieving development and commercialization milestones may be amended) and other obligations of Company pursuant to this Agreement. The terms of and performance under this Agreement, except as may be expressly activities set forth in a mutually agreed the Development Plan shall at all times be designed to SOWbe in compliance with all applicable Laws and to be conducted in accordance with professional and ethical standards customary in the pharmaceutical industry.
(c) Within five (5) days following execution of As between the Parties, Company shall be responsible, at its, its Affiliates’ and/or Third Parties’ sole cost and expense, for all Development activities under this Agreement, Resonant Agreement and Skyworks shall each identify no less than two (2) representatives who will be dedicated to the Development Project (the “Development Team”). Personnel comprising the Development Team shall have the requisite knowledge and expertise necessary to carry out the respective obligations of the parties on Exhibit A and be reasonably familiar with the technology to be used in connection therewith. Any party can change its members of the Development Team upon written notice to the other party so long as such new personnel meet the requirements of this sub-paragraph 2(c)Plan.
Appears in 1 contract
Development. (a) Resonant and Skyworks 4.2.1. The LICENSOR shall each diligently perform be solely responsible for the actions and tasks assigned to them respectivelyperformance of, and substantially all costs relating to, the Phase III Clinical Trial. Any further development of the Product within the Territory shall be the subject to Sections 4.2.2, 4.2.3 and 4.2.4. All data arising from the Phase III Clinical Trial, together with all other data and information requested by any Regulatory Authority, shall, promptly after first becoming available to the LICENSOR or promptly on such request, as applicable, be provided to IMMEDICA. In addition, the schedule LICENSOR shall, promptly upon filing, provide a complete and accurate copy of all material Regulatory Filings submitted to the US Food and Drug Administration for review by IMMEDICA. Subject to the foregoing, IMMEDICA shall itself, or through its Affiliates or Sublicensees, use Commercially Reasonable Efforts to Develop the Product in the Field in the Territory, including conducting any postmarketing commitments (PMCs) for the Product in the Field in the Territory. In connection with its efforts to Develop the Product, and subject to the provision of the data and information by the LICENSOR set forth on Exhibit A attached heretoout in this Section, IMMEDICA shall bear all responsibility and expense for filing Regulatory Filings in the Territory in IMMEDICA’s name and obtaining Regulatory Approval for the Product in the Territory. IMMEDICA will undertake such activities at its sole expense and shall provide to LICENSOR reports regarding IMMEDICA’s progress within [*] following the expiration of each Calendar Year.
4.2.2. The schedule Parties acknowledge that in the Paediatric Investigation Plan (PIP) submitted by LICENSOR in the Territory, the PIP Trial will commence on need to be conducted to obtain the earlier benefit of October 1the approval, 2013 or as soon as practicable following and such trial will be the closing responsibility of Resonant’s private financing. If Resonant the LICENSOR provided always that IMMEDICA shall reimburse LICENSOR for [*] of the out-of-pocket external costs reasonably and Skyworks mutually agreeactually incurred by the LICENSOR, they may execute Statements of Work (each an “SOW”) to further supplement Exhibit A, including to describe (i) contributions of Proprietary Technology solely and other resources by each of Skyworks and Resonant; (ii) adjustments directly in relation to the anticipated timing for completion of each milestone set forth on Exhibit A (each, a “Milestone”); (iii) adjustments to specifications and/or acceptance criteria for the Duplexer to be developed in connection with such Milestone; (iv) additional Milestones; and (v) any adjustments to funding commitments related to the Development Project set forth on Exhibit B. However, no such additional SOW is required or a condition to the obligations in this Agreement or as a condition to commencement conduct of the Development Project, unless agreed mutually in an SOWPIP Trial up to [*]. If an SOW is entered, each such SOW shall automatically be deemed attached to this Agreement as a supplement to Exhibit A upon execution thereof by Skyworks and Resonant without additional action required. Any such mutually executed SOW shall govern such aspects of the development process as specified therein and shall, to the extent stated expressly therein, supersede and replace specified terms of Exhibit A. Any amendments or revisions to any SOW that may be entered Such costs shall be mutually agreed to payable in U.S. Dollars upon receipt by the parties to the SOW IMMEDICA of reasonable written evidence of such external costs, in writingaccordance with Section 6.
(b) Each of the parties agrees to be responsible for its own costs relating to its negotiation of and performance under this Agreement, except as may be expressly set forth in a mutually agreed to SOW.
(c) Within five (5) days following execution of this Agreement, Resonant and Skyworks shall each identify no less than two (2) representatives who will be dedicated to the Development Project (the “Development Team”). Personnel comprising the Development Team shall have the requisite knowledge and expertise necessary to carry out the respective obligations of the parties on Exhibit A and be reasonably familiar with the technology to be used in connection therewith. Any party can change its members of the Development Team upon written notice to the other party so long as such new personnel meet the requirements of this sub-paragraph 2(c).
Appears in 1 contract
Sources: License and Supply Agreement (Aeglea BioTherapeutics, Inc.)
Development. (a) Resonant and Skyworks 4.1.1. LICENSEE shall each diligently perform itself, or through its Affiliates or sublicensees, use Commercially Reasonable Efforts to Develop Products in the actions and tasks assigned to them respectivelyTerritory, and substantially on LICENSEE shall undertake all Development activities at its sole expense. Without limiting the schedule set forth on Exhibit A attached hereto. The schedule will commence on the earlier of October 1foregoing, 2013 or as soon as practicable following the closing of Resonant’s private financing. If Resonant and Skyworks mutually agree, they may execute Statements of Work (each an “SOW”) to further supplement Exhibit A, including to describe (i) contributions of Proprietary Technology and other resources by each of Skyworks and Resonant; (ii) adjustments to the anticipated timing for completion of each milestone set forth on Exhibit A (each, a “Milestone”); (iii) adjustments to specifications and/or acceptance criteria for the Duplexer to be developed in connection with such Milestone; its efforts to Develop Products, LICENSEE shall bear all responsibility and expense for filing Regulatory Filings in LICENSEE’s name and obtaining Regulatory Approval for Products. LICENSEE’s Development activities will be undertaken in accordance with a Development plan (iv) additional Milestones; and (v) any adjustments to funding commitments related to the “Development Project set forth on Exhibit B. HoweverPlan”), no such additional SOW is required or a condition to the obligations in this Agreement or as a condition to commencement of the initial Development Project, unless agreed mutually in an SOW. If an SOW is entered, each such SOW shall automatically be deemed attached to this Agreement as a supplement to Exhibit A upon execution thereof by Skyworks and Resonant without additional action required. Any such mutually executed SOW shall govern such aspects of the development process as specified therein and shall, to the extent stated expressly therein, supersede and replace specified terms of Exhibit A. Any amendments or revisions to any SOW that may be entered shall be mutually Plan being agreed to by the parties in writing as of the date hereof (the “Initial Development Plan”). PFIZER acknowledges that (a) the Initial Development Plan has been based on the due diligence carried out by LICENSEE prior to the SOW in writing.
Effective Date, largely utilizing information furnished to LICENSEE by PFIZER; (b) Each of the parties agrees to be responsible for its own costs relating to its negotiation of such Initial Development Plan is predicated, in part, on clinical data that has not yet been generated; and performance under this Agreement, except as may be expressly set forth in a mutually agreed to SOW.
(c) Within five (5) days following execution such Initial Development Plan is subject to revision from time to time to take into account, among other factors: safety or efficacy concerns, matters related to patent protection, or issues related to present or future marketability or profitability, including existing or anticipated competition, and that such revisions may include seeking Regulatory Approval for different Indications than are contained in the Initial Development Plan. Each Development Plan or amendment shall be treated by both Parties as a good faith statement of LICENSEE’s intentions for the Development of the Product, but such Development Plan shall not be deemed to be a contractual commitment by LICENSEE to undertake all of the efforts described in such Plan or to refrain from making adjustments to such Plan that, in LICENSEE’s reasonable judgment, are necessary in light of factors described in the preceding sentence. LICENSEE shall provide to PFIZER reports regarding LICENSEE’s progress and future plans, including amendments to the Development Plan, every [**] months during the terms of this Agreement, Resonant and Skyworks shall each identify no less than two (2) representatives who Pfizer will be dedicated provided with an opportunity to comment on all amendments to the Development Project Plan as well as all Development and Commercialization activities. Such reports shall include information regarding LICENSEE’s activities with respect to the Milestone events described in Section 5.1.3(a) and, when available, information demonstrating whether or not such Milestone events have been achieved.
4.1.2. Notwithstanding the provisions of the foregoing Section 4.1.1, LICENSEE shall, at a minimum, use Commercially Reasonable Efforts to (the “Development Team”). Personnel comprising a) execute the Development Team shall have Plan; (b) find a formulation that addresses the requisite knowledge and expertise necessary to carry out the respective obligations pharmacokinetic variability of the parties on Exhibit A current formulation of the existing Product (with such formulation activities to begin no later than December 31, 2012); and be reasonably familiar (c) conduct appropriate human studies designed to establish proof of mechanism of a Product (with the technology such studies to be used initiated no later than June 30, 2013), provided that LICENSEE shall not be in connection therewith. Any party can change its members of the Development Team upon written notice to the other party so long as such new personnel meet the requirements breach of this sub-paragraph 2(c)Section 4.1.2 if it fails to undertake the activities described in this Section 4.1.2 by the date specified in this Section 4.1.2 due to factors outside of LICENSEE’s reasonable control.
Appears in 1 contract
Sources: License Agreement (Verastem, Inc.)
Development. 5.1 Upon the signing of this License Agreement, TITAN shall have full legal and financial responsibility for all costs that are incurred and all activities that are undertaken after the signing of this License Agreement, which are related to development, safety and required periodic reporting to the FDA and equivalent ex-U.S. regulatory agency, marketing, regulatory approvals, price registrations, and other activities required by TITAN or its SUBLICENSEE(S) (or their respective agents or distributors) to obtain appropriate government approvals for, and to commercialize, COMPOUND and PRODUCT in the TERRITORY. Other than as expressly provided for herein or in Article II.A. of the Letter of Intent, dated November 19, 1996, between the parties, TITAN shall not assume, nor shall TITAN be liable for, any costs or activities (whether scientific, financial or otherwise) relating to the COMPOUND or PRODUCT that were incurred or undertaken prior to the signing of this License Agreement (including without limitation any costs, expenses, damages, losses, fines, penalties or the like that may be awarded or assessed after the signing of this License Agreement, but which arise out of events and activities that occurred prior to the signing of this License Agreement).
5.2 Provided that the AFFILIATES, SUBLICENSEES and other THIRD PARTIES agree to substantially the same terms of confidentiality in Section 6.4 hereof, TITAN may appoint such AFFILIATES, SUBLICENSEE(S) and other THIRD PARTIES to perform any and all development activities necessary to obtain government approvals for PRODUCT in the TERRITORY. The appointment of any SUBLICENSEE shall require HMRI's prior written consent, which consent shall not be unreasonably withheld.
5.3 TITAN shall, in a manner consistent with the effort TITAN devotes to its own products having the same or similar potential value as PRODUCT, exercise its reasonable commercial efforts and diligence in developing and commercializing PRODUCT, and in undertaking those investigations and actions required to obtain appropriate governmental approvals to market PRODUCT in the TERRITORY. All such activity shall be undertaken at TITAN's expense. HMRI shall use reasonable efforts to assist or provide consultation at TITAN's expense in support of the development of COMPOUND or PRODUCT, but in its discretion may limit its resources and assistance.
5.4 Upon the signing of this License Agreement, TITAN shall inform HMRI in writing which of the contract research organizations ("CROs") and other organizations currently working on development activities relating to COMPOUND and/or PRODUCT which TITAN desires to retain, and those development activities on which TITAN desires to have such CROs and other organizations work. Provided (a) Resonant the contracts can be modified as may be desired by TITAN and Skyworks (b) such CROs release HMRI from any liability thereunder, existing contracts between HMRI and such CROs and other organizations which TITAN wants to assume shall each diligently perform the actions and tasks be assigned to them respectivelyTITAN by HMRI after the signing of this License Agreement by HMRI and TITAN entering into an assignment, release and assumption agreement with respect to each such contract, which shall provide, INTER ALIA, that HMRI shall have no legal, financial or administrative responsibilities related to such contracts as of the date of such assignment. TITAN shall endeavor in good faith to have a CRO which has a pre-existing agreement with HMRI relating to work to be performed on the COMPOUND or PRODUCT, to enter into an agreement with HMRI and TITAN releasing HMRI and TITAN from all liability under such pre-existing agreement. If such CRO is unwilling to grant such release to HMRI, then HMRI in its sole discretion may waive the requirement of a release as to a particular issue(s) raised by such CRO which HMRI in good ▇▇▇▇▇ ▇▇▇▇▇ to be meritorious. TITAN shall be solely responsible for negotiation of contracts with any other CROs and other organizations it desires to work on development activities relating to COMPOUND and/or PRODUCT and TITAN shall bear all legal and financial responsibility under such new contracts.
5.5 Any inventions or discoveries or improvements which arise from TITAN'S, its AFFILIATE'S or SUBLICENSEE'S work relating to the development and/or manufacture of the COMPOUND and/or PRODUCT shall be owned by TITAN, but shall be licensed to HMRI, at HMRI's option on a world-wide, non-exclusive, perpetual basis, at a license fee and/or royalty to be negotiated at such time.
5.6 In the event uses or indications outside the FIELD are identified by HMRI or TITAN, TITAN shall have a right of first negotiation for a separate license from HMRI to develop and commercialize such other uses and indications under terms to be negotiated in good faith at such time. Such right of first negotiation shall mean that HMRI shall offer to TITAN the right to develop and commercialize such uses and indications under a separate license, the financial terms of which may be no less favorable than the financial terms provided for in this License Agreement, except that TITAN shall not be required to pay to HMRI any upfront license fees or milestone payments. If TITAN exercises its right of first negotiation, the parties shall negotiate in good faith for a period of ninety (90) days and, if the parties are unable to enter into a separate definitive written agreement regarding such license by the end of such ninety (90) day period, HMRI or an AFFILIATE shall be free to develop and commercialize such other use or indication itself or to enter into a license or other agreement with a THIRD PARTY, and substantially shall have no further obligations to negotiate with TITAN or further license obligations with respect thereto.
5.7 TITAN shall provide to HMRI regular written reports at least every six (6) months setting forth significant developments and improvements that affect COMPOUND or PRODUCT. From the date of this License Agreement, TITAN shall provide to HMRI on an annual basis, a written report on the schedule set forth on Exhibit A attached hereto. The schedule will commence on the earlier of October 1, 2013 or as soon as practicable following the closing of Resonant’s private financing. If Resonant status and Skyworks mutually agree, they may execute Statements of Work (each an “SOW”) to further supplement Exhibit A, including to describe (i) contributions of Proprietary Technology and other resources by each of Skyworks and Resonant; (ii) adjustments to the anticipated timing for completion of each milestone set forth on Exhibit A (each, a “Milestone”); (iii) adjustments to specifications and/or acceptance criteria for the Duplexer to be developed in connection with such Milestone; (iv) additional Milestones; and (v) any adjustments to funding commitments related to the Development Project set forth on Exhibit B. However, no such additional SOW is required or a condition to the obligations in this Agreement or as a condition to commencement of the Development Project, unless agreed mutually in an SOW. If an SOW is entered, each such SOW shall automatically be deemed attached to this Agreement as a supplement to Exhibit A upon execution thereof by Skyworks and Resonant without additional action required. Any such mutually executed SOW shall govern such aspects progress of the development process as specified therein and shall, and/or registration activities related to the extent stated expressly therein, supersede and replace specified terms of Exhibit A. Any amendments COMPOUND or revisions to any SOW that may be entered shall be mutually agreed to by the parties to the SOW in writingPRODUCT.
(b) Each 5.8 TITAN, or its SUBLICENSEES, shall promptly advise HMRI in writing upon the submission and filing for government regulatory approval to market PRODUCT, and upon the receipt of government regulatory approval to market PRODUCT, in each case in each country in the parties agrees to be responsible for its own costs relating to its negotiation of TERRITORY, and performance under this Agreement, except as may be expressly set forth shall commence marketing PRODUCT in a mutually agreed to SOWsuch country in accordance with Section 5.3.
(c) Within five (5) days following execution of this Agreement, Resonant and Skyworks shall each identify no less than two (2) representatives who will be dedicated to the Development Project (the “Development Team”). Personnel comprising the Development Team shall have the requisite knowledge and expertise necessary to carry out the respective obligations of the parties on Exhibit A and be reasonably familiar with the technology to be used in connection therewith. Any party can change its members of the Development Team upon written notice to the other party so long as such new personnel meet the requirements of this sub-paragraph 2(c).
Appears in 1 contract
Sources: Worldwide License Agreement (Titan Pharmaceuticals Inc)