Provision Language
3. Research Program. Joint Steering Committee
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3.4 Records. Each Party’s Program Participants will keep accurate scientific records, including up–to–date and properly verified scientific notebooks, relating to the Research Program, which records will be sufficient to document any Program Developments. Each Party will make such records available to the other Parties during normal business hours upon reasonable notice. Each Party will, upon request by another Party and at the requesting Party’s expense, promptly provide copies of all such records to the requesting Party.
5. Research Program Communications and Reports
5.1 Scientific Communications. During the Research Term, each Party will disclose to the JSC the Background Technology of such Party that is reasonably necessary for the conduct of the Research Program. Furthermore, during the Research Term, Principal Investigator, the Alnylam Principal Scientist and the AlCana Principal Scientist (or their respective designees) will meet or communicate regularly to discuss the Research Program status and results and to consider, based upon that status or those results, what modifications to the Research Program Workplan, if any, should be presented to the JSC for consideration.
5.2 Required Reports. During the Research Term, each Party will submit to the JSC at the end of each Contract Quarter a written report summarizing (a) the status of the Research Program, (b) any Program Developments and publications/abstracts made during such Contract Quarter, and (c) Research Program funds expended during that period.
7. Program Developments and Program Materials
7.1 Disclosure of Patentable Program Developments. The Parties will promptly and fully disclose to each other in writing any and all patentable Program Developments. Disclosure of Program Developments (“Disclosure Notices”) will be sent to the other Parties as specified in the notice provisions of Section 13.9 below. For clarity, submission of reports under Section 5.2 and 10.6.2 or submission of manuscripts under Section 9.2 do not fulfill the requirements of this Section 7.1.
8. Collaboration IP
8.2 UBC Controlled IP
8.2.3 Notice of Sublicenses. Alnylam will notify UBC and AlCana promptly after it enters into each sublicensing agreement. Alnylam will provide to UBC and AlCana a copy of such sublicense agreement. Any such copy may contain reasonable redactions as Alnylam may make; provided, that such redactions do not include provisions necessary to demonstrate compliance with the requirements of this Agreement.
8.3 Diligence. Alnylam shall use Commercially Reasonable Efforts to research, develop and commercialize a Licensed Product in the Field of Use. […]
In addition, Alnylam shall, with respect to each Licensed Product, and subject to the provisions of Article 9:
(i) promptly advise UBC and AlCana of any material changes made from time to time with respect to Alnylam’s research, development and commercialization program for Licensed Products or any issues of which Alnylam becomes aware that may materially and adversely affect Alnylam’s research, development and commercialization program or its ability to research, develop, and commercialize a Licensed Product;
(ii) provide UBC and AlCana with notice in writing if any of the events in Sections 8.3(a) or (b) above occur, within [**] days after the occurrence of such events;
(iii) provide UBC and AlCana with notice in writing of the date of First Commercial Sale of any Licensed Product in each country;
(iv) meet with representatives of UBC and AlCana, as often as UBC and AlCana may reasonably request, but no more frequently than [**] every [**] months, to discuss the plans for research, development and commercialization of a Licensed Product; and
(v) provide to UBC and AlCana, as often as UBC and AlCana may reasonably request, but no more frequently than [**] every [**] months, a written summary of current plans to commercialize a Licensed Product, including, without limitation, a summary of the current and proposed research, development, commercialization, marketing and sales plans for such Licensed Product.
8.4 Compensation for Exclusive License
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8.4.2. Royalties.
(c) Other Royalty Provisions. Royalties shall become due and payable within [**] days after each Contract Quarter during the applicable Royalty Term and shall be calculated with respect to Net Sales in the immediately preceding Contract Quarter. Along with its royalty payment hereunder, each Payor and its Related Parties shall provide Payee with a royalty report (in a form that may be reasonably prescribed by the Payee from time to time) containing the calculation of such royalty. No royalties shall be due upon the sale or other transfer among a Payor and its Related Parties, but in such cases the royalty shall be due and calculated upon such Payor’s or its Related Parties’ Net Sales to the first independent Third Party. No royalties shall accrue on the sale or other disposition of the Licensed Product by a Payor or its Related Parties for use in a clinical study sponsored or funded by a Payor or its Related Parties or on the disposition of a Licensed Product in reasonable quantities by a Payor or its Related Parties as samples (promotion or otherwise) or as donations (for example, to non–profit institutions or government agencies for a non–commercial purpose). Other than as set out in this subsection, any other transaction, disposition, or other dealing involving the sale or other transfer of Licensed Products that is not made at fair market value is deemed to have been made at fair market value, and the fair market value of such sale or transfer will be added to and deemed part of the Net Sales and will be included in the calculation of royalties under this Agreement.
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8.4.5 Records and Audits. Each Payor shall keep, and shall require all its Related Parties to keep and maintain, correct and complete books of accounts and other records containing all information and data that may be necessary to ascertain and verify the Net Sales of all Licensed Products, the royalties payable under this Agreement and the achievement of all milestone events. Such accounts and records, and the calculation of royalties will be carried out in accordance with U.S. Generally Accepted Accounting Principles (or such other generally accepted accounting methodology used by such Payor’s Related Parties) applied on a consistent basis. During the Agreement Term and for a period of [**] years following its termination or expiration, the nominee of AlCana and UBC (such nominee, the “Auditing Party”) shall have the right from time to time (not to exceed [**] during each calendar year) to have an independent certified public accountant inspect such books and records of a Payor and/or its Affiliates at the Auditing Party’s expense. Such inspection shall be conducted after reasonable prior notice by the Auditing Party to such Payor during such Payor’s ordinary business hours, shall not be more frequent than [**] during each calendar year and may cover only the [**] years immediately preceding the date of the audit. Any such independent certified accountant shall be reasonably acceptable to such Payor, shall execute such Payor’s standard form of confidentiality agreement, and shall be permitted to share with the Auditing Party solely its findings (the “Findings”) with respect to the accuracy of the Net Sales, royalties and milestones reported as payable under this Agreement. UBC and AlCana may also share with each other such Findings. If such accounting determines that such Payor paid Payee less than the amount properly due in respect of any period which is the subject of the audit, then such Payor will reimburse Payee such amount, and if the amount underpaid exceeds five percent (5%) of the amount actually due and [**] dollars ($[**]), such Payor will also reimburse the Auditing Party for the costs of such accounting (including the fees and expenses of the certified public accountant). In the event such accounting determines that such Payor paid Payee more than the amount properly due in respect of any period which is the subject of the audit, then any excess payments made by such Payor shall be credited against future amounts due to Payee from such Payor, or if no such future amounts are reasonably expected to be due to Payee from such Payor, then Payee shall reimburse such Payor promptly for any overpayment by such Payor.