Scope of Collaboration As part of the collaboration, the Controllers will act as Joint Controller. The roles of the Controller and the associated tasks are specified in more detail in Appendix 1. If one party is solely responsible for a data processing operation, this party will implement all relevant data protection provisions on its own responsibility. However, such data processing procedures are not subject to this Agreement. Joint data processing and the type of Personal Data collected and processed within the framework of collaboration are specified in Appendix 1.
Research Collaboration 3.7.1 Aarvik shall carry out the activities of each Work Item and deliver the required Data Package and/or deliverables in accordance with the applicable SOW. Without limiting the generality of the foregoing, Aarvik shall, in accordance with the applicable SOWs and the timeline approved by JRC, apply the Aarvik IP to (i) design and synthesize Collaboration Compounds, and (ii) by itself or through subcontractor(s), [***]. During the Research Term, if any Party identifies any Third Party Patent or Know-How that is necessary or reasonably useful for any activity under the SOWs but has not been included in the Aarvik IP, then such Party shall immediately inform the other Party and the Parties shall discuss in good faith the need of obtaining a license from such Third Party.
3.7.2 No later than [***] ([***]) days after completion of the [***], Aarvik shall, to the extent not already provided to ArriVent, deliver the Data Packages and all other deliverables required under the [***], as well as the results of the Patentability and FTO Analysis as described in Section 3.2.3, to ArriVent. ArriVent shall have the sole discretion to decide whether or not to advance any Collaboration Compound and which Collaboration Compound(s) will be advanced for further studies beyond the [***]. ArriVent shall inform Axxxxx of its decision in writing. If AxxxXxxx decides to advance the Collaboration Program to [***], ArriVent shall make the payment for the [***] pursuant to Section 6.2.1.
3.7.3 If, upon completion of the [***] for the Collaboration Program, AxxxXxxx decides not to advance the Collaboration Program to [***], ArriVent may terminate the Collaboration Program. If AxxxXxxx decides to advance the Collaboration Program to [***], ArriVent shall make the payment for the [***] pursuant to Section 6.2.1.
3.7.4 No later than [***] ([***]) days after completion of the [***], Aarvik shall, to the extent not already provided to ArriVent, deliver all Data Packages and deliverables required under the [***] to ArriVent. ArriVent shall have the sole discretion to decide whether or not to advance any Collaboration Compound and which Collaboration Compound(s) will be advanced for further studies beyond the [***]. ArriVent shall inform Axxxxx of its decision in writing.
3.7.5 No later than [***] ([***]) days after completion of the [***], Aarvik shall, to the extent not already provided to ArriVent, deliver all Data Packages and deliverables required under the [***] to ArriVent.
3.7.6 Within [***] ([***]) days after completion of the [***], Aarvik shall deliver to ArriVent a full report on all key results and findings of the Collaboration Program, and such other data, results and information as ArriVent may deem necessary for it to determine whether or not to exercise the Option (the “Full Report”).
Research Matters By entering into this Agreement, the Placement Agent does not provide any promise, either explicitly or implicitly, of favorable or continued research coverage of the Company and the Company hereby acknowledges and agrees that the Placement Agent’s selection as a placement agent for the Offering was in no way conditioned, explicitly or implicitly, on the Placement Agent providing favorable or any research coverage of the Company. In accordance with FINRA Rule 2711(e), the parties acknowledge and agree that the Placement Agent has not directly or indirectly offered favorable research, a specific rating or a specific price target, or threatened to change research, a rating or a price target, to the Company or inducement for the receipt of business or compensation.
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).
Joint Patents With respect to any potentially patentable Joint Invention, the Parties shall meet and agree upon which Party shall prosecute and maintain Patent applications covering such Joint Invention (any such Patent application and any Patents issuing therefrom, a “Joint Patent”) in particular countries and jurisdictions throughout the world. Unless otherwise agreed by the Parties, Xxxxxx will prosecute and maintain any Joint Patents in the Licensed Territory, and Onconova will prosecute and maintain the Joint Patents outside the Licensed Territory, subject to the Parties coordinating their efforts as appropriate to make such prosecution activities as efficient, convenient, and harmonious as possible. The Parties ** all expenses of filing, prosecuting and maintaining such Joint Patents. The Party that prosecutes a Joint Patent (the “Prosecuting Party”) shall provide the other Party the opportunity to review and comment on any and all such prosecution efforts regarding the applicable Joint Patent in the particular jurisdictions, and such other Party shall provide the Prosecuting Party reasonable assistance in such efforts; provided that the Prosecuting Party shall have final control over such prosecution efforts after reasonably considering the other Party’s comments, if any. The Prosecuting Party shall provide the other Party with a copy of all material communications from any Patent authority in the applicable jurisdictions regarding the Joint Patent being prosecuted by such Party, and shall provide drafts of any material filings or responses to be made to such patent authorities a reasonable amount of time in advance of submitting such filings or responses. In particular, each Party agrees to provide the other Party with all information necessary or desirable to enable the other Party to comply with any duty of candor and/or duty of disclosure requirements of any Patent authority. Except to the extent a Party is restricted by the licenses granted by such Party to the other Party under the terms of this Agreement, and/or the other covenants contained in this Agreement, each Party shall be entitled to practice, and grant licenses to Third Parties and Affiliates of such Third Parties to practice, the Joint Patents and all Joint Inventions without restriction or an obligation to account to the other Party, and the other Party shall consent and hereby consents, without additional consideration, to any and all such licenses.
License Types (a) A Team License shall mean a subscription license that provides a limited number of licenses to a set amount of developers for a named Customer. Customer must procure enough active licenses for each individual who has Programmatic Access. A Team License only grants rights to a named Customer and does not extend any right, in any form, to any parent or subsidiary company of Customer. A Team License cannot be used as a floating license.
(b) A Project License shall mean a subscription license which covers one named Customer application. The license fees are based on the total number of developers working on a named project, regardless of whether such developers are directly using the Licensed Product. For the purposes of pricing and license administration, a “Project Group” is deemed to be a distinct Customer software team within a Customer’s business unit that works towards a distinct business purpose for the benefit of a single application. Customer is required to identify the name of each such Project Group to Syncfusion; such name must be unambiguous in nature. It is acknowledged and agreed by Customer that each identified Project Group shall exist for a valid business purpose and not just as a means for consolidating software licenses to minimize license fees that are otherwise due. If, in the sole opinion of Syncfusion, multiple Customer teams would each individually meet the above definition of a Project Group, such multiple teams shall not be combined for the purpose of consolidating licenses under a single Project Group. Customer is responsible for providing information about each such Project Group to Syncfusion. By entering into this Agreement, Customer represents that after the effective date, it will not withhold information that Syncfusion requires to properly license each such Project Group, and further agrees that any misrepresentation in this regard constitutes a material breach of this Agreement.
(c) A Division License shall mean a subscription license which will cover one named Division and allow for development work on more than one project within such Division. A Division shall mean a business unit within Customer’s organization that works towards a distinct business purpose. Customer is required to identify the name of such Division to Syncfusion; such name must be unambiguous in nature. License fee determinations will be at the sole discretion of Syncfusion and be based on such factors including, but not limited to, Customer’s Division size, developer count, and the scope of the Division’s business purpose. By entering into this Agreement, Customer acknowledges that it is responsible for providing information about the named Customer Division to Syncfusion sufficient for Syncfusion to price the Division License, and Customer represents that it will not withhold information that Syncfusion requires to properly license each such named Customer division, and further agrees that any misrepresentation in this regard constitutes a material breach of this Agreement.
(d) A Global License shall mean a subscription license for all development for a named Customer, where the license fees are based on the overall size of a named Customer. A Global License only grants rights to a named Customer and does not extend any right, in any form, to any parent or subsidiary company of Customer.
(e) A Retail License shall mean a single named user, non-transferable license to use the Licensed Product. Retail Licenses will only made available to Customers in Syncfusion’s sole discretion and only when the number of such End-Users is finite and readily ascertainable. Accordingly, Syncfusion will make a determination as to whether or not the provision of Retail Licenses is appropriate under the circumstances applicable to any given Customer, and Syncfusion reserves the right, in its sole discretion, to refuse to make available Retail Licenses to a Customer and instead require a given Customer to procure a Project License, Division License, or Global License as circumstances dictate. A Retail License only grants rights to a named Customer and does not extend any right, in any form, to any parent or subsidiary company of Customer.
Collaboration 31.1 If the Buyer has specified in the Order Form that it requires the Supplier to enter into a Collaboration Agreement, the Supplier must give the Buyer an executed Collaboration Agreement before the Start date.
31.2 In addition to any obligations under the Collaboration Agreement, the Supplier must:
31.2.1 work proactively and in good faith with each of the Buyer’s contractors
31.2.2 co-operate and share information with the Buyer’s contractors to enable the efficient operation of the Buyer’s ICT services and G-Cloud Services
License of Intellectual Property Each Party (a “Licensor”) grants the other Party (a “Licensee”) the non-exclusive, royalty-free, paid-up, worldwide, irrevocable, right, during the term of this Agreement, to use the Licensor’s Intellectual Property solely for the purposes of this Agreement and to carry out the Party’s functions consistent with its responsibilities and authority as set forth in the enable legislation and regulations. Such licenses shall not give the Licensee any ownership interest in or rights to the Intellectual Property of the Licensor. Each Licensee agrees to abide by all third-party license and confidentiality restrictions or obligations applicable to the Licensor’s Intellectual Property of which the Licensor has notified the Licensee in writing.
Prosecution and Maintenance of Patent Rights (a) At the initiative of ProPhase or Licensor, the Parties shall consult in good faith with each other regarding the filing, prosecution, and maintenance of all Licensed Patents. The Licensed Patents shall be diligently filed, prosecuted and maintained by Licensor using reputable counsel. Licensor shall keep ProPhase reasonably informed with regard to the preparation, filing, prosecution, and maintenance of the Licensed Patents, including by providing ProPhase (or its designee) copies of office actions issued from patent offices, proposed responses to such office actions, and any other patent related filings, to be made to such patent authority in the Territory sufficiently in advance of submitting such filings or responses so as to allow for a reasonable opportunity for ProPhase to review and comment thereon. Licensor shall consider in good faith any such comments for incorporation into such draft. Licensor represents that during the Term that (a) all Licensed Patents will be diligently prosecuted in the respective patent offices in the Territory in accordance with applicable laws, rules and regulations, (b) all Licensed Patents will be filed and maintained properly and correctly, (c) Licensor will pay all applicable fees on or before the due date for payment, and (d) all Licensed Patents will identify each and every inventor of the claims thereof as determined in accordance with the laws of the jurisdiction in which such Patent is filed. Prophase shall reimburse Global BioLife for reasonable attorney fees and patent office costs associated with the prosecution and maintenance of the Licensed Patents on a quarterly basis commencing on September 30, 2022.
(b) If, at any time during the Term, the Parties may mutually agree that it is undesirable, as to one or more countries, to file, prosecute or maintain any Licensed Patent, then Global BioLife shall have discretion to refrain from filing, prosecuting and/or maintaining any Licensed Patent or permitting the Licensed Patent to lapse.
(c) The Parties shall cooperate with each other and discuss, in good faith, the Patent Rights within the Licensed Patents Covering the Licensed Compound and Licensed Products to enable Prophase to make filings with Regulatory Authorities, as required or allowed in connection with (A) in the United States, the FDA’s Orange Book and (B) outside the United States, under the national implementations of Article 10.l(a)(iii) of Directive 2001/EC/83 or other international equivalents thereof. Global BioLife shall cooperate with Prophase’s reasonable requests in connection therewith, including meeting any submission deadlines, in each case, to the extent required or permitted by applicable law.
(d) The Parties shall cooperate in obtaining Patent Term Extensions pursuant to 35 U.S.C. § 156 and foreign counterparts and equivalents thereof, including supplementary protection certificates, to the extent such extensions are available with respect to the applicable Patent Rights (“Extension Activities”).
Research Use The Requester agrees that if access is approved, (1) the PI named in the DAR and (2) those named in the “Senior/Key Person Profile” section of the DAR, including the Information Technology Director and any trainee, employee, or contractor1 working on the proposed research project under the direct oversight of these individuals, shall become Approved Users of the requested dataset(s). Research use will occur solely in connection with the approved research project described in the DAR, which includes a 1-2 paragraph description of the proposed research (i.e., a Research Use Statement). Investigators interested in using Cloud Computing for data storage and analysis must request permission to use Cloud Computing in the DAR and identify the Cloud Service Provider (CSP) or providers and/or Private Cloud System (PCS) that they propose to use. They must also submit a Cloud Computing Use Statement as part of the DAR that describes the type of service and how it will be used to carry out the proposed research as described in the Research Use Statement. If the Approved Users plan to collaborate with investigators outside the Requester, the investigators at each external site must submit an independent DAR using the same project title and Research Use Statement, and if using the cloud, Cloud Computing Use Statement. New uses of these data outside those described in the DAR will require submission of a new DAR; modifications to the research project will require submission of an amendment to this application (e.g., adding or deleting Requester Collaborators from the Requester, adding datasets to an approved project). Access to the requested dataset(s) is granted for a period of one (1) year, with the option to renew access or close-out a project at the end of that year. Submitting Investigator(s), or their collaborators, who provided the data or samples used to generate controlled-access datasets subject to the NIH GDS Policy and who have Institutional Review Board (IRB) approval and who meet any other study specific terms of access, are exempt from the limitation on the scope of the research use as defined in the DAR.
