PTO/AIA/15 (10-17)
`Approved for use through 11/30/2020. OMB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995 no personsare required to respond to a collection of information unless it displays a valid OMB control number.
`UTILITY
`066859/543317
`PATENT APPLICATION
`
`TRANSMITTAL
`
`(Onlyfor new nonprovisional applications under 37 CFR 1.53(b}}
`
`APPLICATION ELEMENTS
`See MPEP chapter 600 concerning utility patent application contents.
`
`Priority Mail Express®
`Label No.
`
`ADDRESS TO:
`
`
`
`
`
`
`8.
`
`
`
`
`
`
`-[] Fee Transmittal Form
`(PTO/SB/17 or equivalent)
`Applicant asserts smallentity status.
`See 37 CFR 1.27
`Applicant certifies micro entity status. See 37 CFR 1.29.
`Applicant must attach form PTO/SB/15A or B or equivalent.
`]
`Specification
`[Total Pages 91
`Both the claims and abstract must start on a new page.
`(See MPEP § 608.01(a) for information on the preferred arrangement)
`Drawing(s) (35 U.S.C. 113)
`[Total Sheets *
`]
`. Inventor’s Oath or Declaration
`[Total Pages 3
`]
`(including substitute statements under 37 CFR 1.64 and assignments
`ving as an oath or declaration under 37 CFR 1.63(e}}
`LE] Newly executed (original or copy)
`[e] A copy from a prior application (37 CFR 1.63({d))
`7. [+] Application Data Sheet
`* See note below.
`See 37 CFR 1.76 (PTO/AIA/14 or equivalent)
`CD-ROM or CD-R
`in duplicate,large table, or Computer Program (Appendix)
`CJ Landscape Table on CD
`9. Nucleotide and/or Amino Acid Sequence Submission
`(if applicable, items a. —c. are required)
`a. C] Computer Readable Form (CRF)
`b. | Specification SequenceListing on:
`i. [| CD-ROM orCD-R (2 copies); or
`ii. | Paper
`c. C] Statementsverifying identity of above copies
`*Note:
`(1) Benefit claims under 37 CFR 1.78 and foreign priority claims under 1.55 must be included in an Application Data Sheet (ADS).
`(2) For applications filed under 35 U.S.C. 111, the application must contain an ADSspecifying the applicant if the applicant is an
`assignee, person to whom the inventor is under an obligation to assign, or person who otherwise showssufficient proprietary
`interest in the matter. See 37 CFR 1.46(b).
`19. CORRESPONDENCE ADDRESS
`
`12.
`
`13.
`
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`ACCOMPANYING APPLICATION PAPERS
`: LC] AssignmentPapers
`(caver sheet & document(s)
`Name ofAssignee
`
`11. [| 37 CFR 3.73(c) Statement
`Powerof Attorney
`
`(whenthereis an assignee)
`
`English Translation Document
`(if applicable)
`Information Disclosure Statement
`(PTO/SB/08 or PTO-1448)
`[| Copiesofcitations attached
`Preliminary Amendment
`Return Receipt Postcard
`(MPEP § 503) (Should be specifically itemized)
`Certified Copy of Priority Document(s}
`(ifforeign priority is claimed)
`Nonpublication Request
`Under 35 U.S.C. 122(b)(2)(B)(i). Applicant must attach form PTO/SB/35
`or equivalent.
`Other:
`
`.
`
`Requestfor Prioritized Examination
`
`
`
`OR [| Correspondenceaddress below
`
`The address associated with Customer Number; 90826
`Name
`Address
`city [|statePT ain conte
`county|si TelephonePE
`signature|/brian |. skelton/foae=|January 27, 2020
`N
`R
`trat
`N
`
`(print/tyge)|Brian L. Skelton iAtiomey/Agent) |DO893
`
`This collection of information is required by 37 CFR 1.53(b). The information is required to obtain or retain a benefit by the public which is to file (and by the USPTO
`lo process) an applicalion. Confidentialily is governed by 35 U.S.C. 122 and 37 CFR 1.11 and 1.14. This collection is eslimaled lo lake 12 minules lo complete,
`including gathering, preparing, and submitting the completed application form to the USPTO. Time will vary depending upon the individual case. Any comments on
`the amountof time you require to complete this form and/or suggestions for reducing this burden, should be sent to the Chief Information Officer, U.S. Patent and
`TrademarkOffice, U.S. Department of Commerce, P.O. Box 1450, Alexandria, VA 22313-1450. DO NOT SEND FEES OR COMPLETED FORMSTO THIS ADDRESS. SEND
`TO: Commissionerfor Patents, P.O. Box 1450, Alexandria, VA 22313-1450.
`if you need assistance in completing the form, call 1-800-PTO-9199 and select option 2.
`
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`Privacy Act Statement
`
`The Privacy Act of 1974 (P.L. 93-579) requires that you be given certain information in connection with your
`submission of the attached form related to a patent application or patent. Accordingly, pursuant to the
`requirements of the Act, please be advised that: (1) the general authority for the collection of this information is
`35 U.S.C. 2(b)(2); (2) furnishing of the information solicited is voluntary; and (3) the principal purpose for which
`the information is used by the U.S. Patent and Trademark Office is to process and/or examine your submission
`related to a patent application or patent.
`If you do not furnish the requested information, the U.S. Patent and
`Trademark Office may not be able to process and/or examine your submission, which may result in termination
`of proceedings or abandonment of the application or expiration of the patent.
`
`The information provided by you in this form will be subject to the following routine uses:
`
`1. The information on this form will be treated confidentially to the extent allowed under the Freedom of
`Information Act (6 U.S.C. 552) and the Privacy Act (5 U.S.C 552a). Records from this system of
`records may be disclosed to the Department of Justice to determine whether disclosure of these
`records is required by the Freedom ofInformation Act.
`2. A-record from this system of records may be disclosed, as a routine use, in the course of presenting
`evidence to a court, magistrate, or administrative tribunal, including disclosures to opposing counsel in
`the course of settlement negotiations.
`to a Member of Congress
`3. A record in this system of records may be disclosed, as a routine use,
`submitting a request involving an individual,
`to whom the record pertains, when the individual has
`requested assistance from the Member with respect to the subject matter of the record.
`4. Arecord in this system of records may bedisclosed, as a routine use, to a contractor of the Agency
`having need for the information in order to perform a contract. Recipients of information shall be
`required to comply with the requirements of the Privacy Act of 1974, as amended, pursuant to 5 U.S.C.
`552a(m).
`5. A record related to an International Application filed under the Patent Cooperation Treaty in this
`system of records may be disclosed, as a routine use,
`to the International Bureau of the World
`Intellectual Property Organization, pursuant to the Patent Cooperation Treaty.
`6. A record in this system of records may be disclosed, as a routine use, to another federal agency for
`purposesof National Security review (35 U.S.C. 181) and for review pursuant to the Atomic Energy Act
`(42 U.S.C. 218(c)).
`7. Arecord from this system of records may be disclosed, as a routine use, to the Administrator, General
`Services, or his/her designee, during an inspection of records conducted by GSA as part of that
`agency’s responsibility to recommend improvements in records managementpractices and programs,
`under authority of 44 U.S.C. 2904 and 2906. Such disclosure shall be made in accordance with the
`GSAregulations governing inspection of records for this purpose, and any other relevant(/.e., GSA or
`Commerce) directive. Such disclosure shall not be used to make determinations about individuals.
`8. A record from this system of records may be disclosed, as a routine use, to the public after either
`publication of the application pursuant to 35 U.S.C. 122(b) or issuance of a patent pursuant to 35
`U.S.C. 151. Further, a record may be disclosed, subject to the limitations of 37 CFR 1.14, as a routine
`use, to the public if the record was filed in an application which became abandoned or in which the
`proceedings were terminated and which application is referenced by either a published application, an
`application open to public inspection or an issued patent.
`9. Arecord from this system of records maybe disclosed, as a routine use, to a Federal, State, or local
`law enforcement agency,
`if the USPTO becomes aware of a violation or potential violation of law or
`regulation.
`
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`Doc Code: TRACK1.REQ
`Document Description: TrackOne Request
`
`aPTO/AIA/424 (04-14)
`
`CERTIFICATION AND REQUESTFOR PRIORITIZED EXAMINATION
`UNDER 37 CFR 1.102(e) (Page 1 of 1)
`
`First Named
`
`John Maloney
`
`Nonprovisional Application Number(if
`
`STABLE, HIGHLY PURE L-CYSTEINE COMPOSITIONS FOR INJECTION AND METHODS OF USE
`
`APPLICANT HEREBYCERTIFIES THE FOLLOWING AND REQUESTSPRIORITIZED EXAMINATION FOR
`THE ABOVE-IDENTIFIED APPLICATION.
`
`1. The processing fee set forth in 37 CFR 1.17(i)(1) and the prioritized examination fee set forth in
`3/7 CFR 1.17(c) have been filed with the request. The publication fee requirement is met
`because that fee, set forth in 37 CFR 1.18(d), is currently $0. The basic filing fee, search fee,
`and examination fee are filed with the request or have been already been paid.
`| understand
`that any required excess claims fees or application size fee must be paid for the application.
`
`| understand that the application may not contain, or be amendedto contain, more than four
`independentclaims, more than thirty total claims, or any multiple dependent claims, and that
`any request for an extension oftime will cause an outstanding Track | request to be dismissed.
`
`3. The applicable box is checked below:
`
`Original Application (Track One)
`
`- Prioritized Examination under § 1.102(e)(1
`
`i.
`
`(a) The application is an original nonprovisional utility application filed under 35 U.S.C. 111(a).
`This certification and requestis being filed with the utility application via EFS-Web.
`
`(b) The application is an original nonprovisional plant application filed under 35 U.S.C. 111(a).
`This certification and requestis being filed with the plant application in paper.
`
`An executed inventor’s oath or declaration under 37 CFR 1.63 or 37 CFR 1.64 for each
`inventor, or the application data sheet meeting the conditions specified in 37 CFR 1.53(f)(3)(i) is
`filed with the application.
`
`signature/Oryan |. skelton/
`Name Bryan L. Skelton
`
`
`
`
`(Print/Typed
`Registration Number
`
`
`
`A requestfor continued examination has been filed with, or prior to, this form.
`If the application is a utility application, this certification and request is being filed via EFS-Web.
`iii. The application is an original nonprovisional utility application filed under 35 U.S.C. 111(a), or is
`a national stage entry under 35 U.S.C. 371.
`iv. This certification and requestis being filed prior to the mailing of a first Office action responsive
`to the request for continued examination.
`No prior request for continued examination has been grantedprioritized examination status
`under 37 CFR 1.102(e)(2).
`
`new 220-01-27
`Practitioner
`50893
`
`This form must be signed in accordance with 37 CFR 1.33. See 37 CFR 1.4(d) for signature requirements and certifications.
`Note:
`Submit muitiple forms if more than one signature is required.*
`
`
`
`*Total of
`
`1
`
`forms are submitted.
`
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`Privacy Act Statement
`
`The Privacy Act of 1974 (P.L. 93-579) requires that you be given certain information in connection with your
`submission of the attached form related to a patent application or patent. Accordingly, pursuant to the requirements of
`the Act, please be advised that: (1) the general authority for the collection of this information is 35 U.S.C. 2(b)(2); (2)
`furnishing of the information solicited is voluntary; and (3) the principal purpose for which the information is used by the
`U.S. Patent and Trademark Office is to process and/or examine your submission related to a patent application or
`patent.
`If you do not furnish the requested information, the U.S. Patent and Trademark Office may not be able to
`process and/or examine your submission, which may result in termination of proceedings or abandonment of the
`application or expiration of the patent.
`
`The information provided by you in this form will be subject to the following routine uses:
`
`1. The information on this form will be treated confidentially to the extent allowed under the Freedom of
`Information Act (5 U.S.C. 552) and the Privacy Act (5 U.S.C 552a). Records from this system of records may
`be disclosed to the Department of Justice to determine whether disclosure of these records is required by the
`Freedom of Information Act.
`2. Arecord from this system of records may be disclosed, as a routine use, in the course of presenting evidence
`to a court, magistrate, or administrative tribunal, including disclosures to opposing counsel in the course of
`settlement negotiations.
`3. Arecord in this system of records may be disclosed, as a routine use, to a Member of Congress submitting a
`requestinvolving an individual, to whom the record pertains, when the individual has requested assistance from
`the Member with respect to the subject matter of the record.
`4. Arecord in this system of records may be disclosed, as a routine use, to a contractor of the Agency having
`need for the information in order to perform a contract. Recipients of information shall be required to comply
`with the requirements of the Privacy Act of 1974, as amended, pursuant to 5 U.S.C. 552a(m).
`5. Arecord related to an International Application filed under the Patent Cooperation Treaty in this system of
`records may be disclosed, as a routine use, to the International Bureau of the World Intellectual Property
`Organization, pursuant to the Patent Cooperation Treaty.
`6. Arecord in this system of records may be disclosed, as a routine use, to another federal agency for purposes
`of National Security review (35 U.S.C. 181) and for review pursuant to the Atomic Energy Act (42 U.S.C.
`218(c)).
`7. Arecord from this system of records may be disclosed, as a routine use, to the Administrator, General
`Services, or his/her designee, during an inspection of records conducted by GSAaspart of that agency’s
`responsibility to recommend improvements in records management practices and programs, under authority of
`44 U.S.C. 2904 and 2906. Such disclosure shall be made in accordance with the GSA regulations governing
`inspection of records for this purpose, and any other relevant (/.e., GSA or Commerce) directive. Such
`disclosure shall not be used to make determinations about individuals.
`8. Arecord from this system of records may be disclosed, as a routine use, to the public after either publication of
`the application pursuant to 35 U.S.C. 122(b) or issuance of a patent pursuant to 35 U.S.C. 151. Further, a
`record may be disclosed, subject to the limitations of 37 CFR 1.14, as a routine use, to the public if the record
`wasfiled in an application which became abandonedor in which the proceedings were terminated and which
`application is referenced by either a published application, an application open to public inspection or an issued
`patent.
`9. Arecord from this system of records may be disclosed, as a routine use, to a Federal, State, or local law
`enforcement agency, if the USPTO becomesaware of a violation or potential violation of law or regulation.
`
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`

`PTO/AIA/14 (02-18)
`Approved for use through 11/30/2020. OMB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.
`
`Application Number
`
`Title of Invention
`
`STABLE, HIGHLY PURE L-CYSTEINE COMPOSITIONS FOR INJECTION AND METHODS OF USE
`
`The application data sheetis part of the provisional or nonprovisional application for whichit is being submitted. The following form contains the
`bibliographic data arranged in a format specified by the United States Patent and Trademark Office as outlined in 37 CFR 1.76.
`This document may be campleted electronically and submitted to the Office in electronic format using the Electronic Filing System (EFS) or the
`document may be printed and included in a paper filed application.
`
`
`
`
`
` .
`
`. Attorney Docket Number|066859/543317
`
`
`Application Data Sheet 37 CFR 1.76
`
`
`
`
`
`Secrecy Order 37 CFR 5.2:
`
`g Portions orall of the application associated with this Application Data Sheet mayfall under a Secrecy Order pursuantto
`37 CFR 5.2 (Paper filers only. Applications that fall under Secrecy Order may notbefiled electronically.)
`
`Inventor Information:
`
`Inventor
`
`1
`
`
`
`Legal Name
`
`Prefix} Given Name
`Middle Name
`Family Name
`Suffix
`
`Mailing Addressof Inventor:
`
`Address1
`c/o Exela Pharma Sciences, LLC
`
`Address 2
`1245 Blowing Rock Blvd
`
`ci
`Ne
`
`
`
`28645 Country iPostal Code US
`
`Inventor
`2
`
`Suffix rr
`
`Legal Name
`Prefix)GivenName Middle Name
`
`Family Name
`
`Residence Information (Select One)
`
`(e) US Residency
`
`(_) NonUSResidency
`
`(C) Active USMilitary Service
`
`Mailing Addressof Inventor:
`
` cfo Exela Pharma Sciences, LLC
`
`Address 1
`
`Address 2
`1245 Blowing Rock Blvd
`
`
`
`
`Postal Code
`
`Inventor
`Legal Name
`
`28645
`
`US
`
`3
`
`Prefix) Given Name
`Middle Name
`Family Name
`Suffix
`
`Phanesh
`Koneru
`
`(e) US Residency () NonUSResidencyResidenceInformation (Select One) () Active USMilitary Service
`
`EFS Web 2.2.13
`
`
`
`
`
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`
`
`
`Maloney
`John
`() Active US Military Service
`©) NonUSResidency
`Residence Information (Select One) () US Residency
`
`City|Salisbury Country of Residence|USState/Province
`
`
`
`
`
`
`
`
`
`
`
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`

`PTO/AIA/14 (02-18)
`Approved for use through 11/30/2020. OMB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, na persons are required to respond to a collection of information unless it contains a valid OMB control number.
`
`. Attorney Docket Number|066859/543317.
`
`
`
`
`
`
`
`
`
`Application Data Sheet 37 CFR 1.76 Application Number
`
`
`
`
`
`City|Waxhaw State/Province|NC Country of Residence|US
`
`Title of Invention
`
`STABLE, HIGHLY PURE L-CYSTEINE COMPOSITIONS FOR INJECTION AND METHODS OF USE
`
` Mailing AddressofInventor:
`Address1
`c/o Exela Pharma Sciences, LLC
`
`Address 2
`
`
`
`1245 Blowing Rock Blvd
`
`City
`Lenoir
`State/Province
`NC
`
`Postal Code
`28645
`Country
`us
`
`Inventor
`Inventors Must Be Listed - Additional
`All
`generated within this form by selecting the Add button.
`
`Information blocks may be
`
`
`
`CorrespondenceInformation:
`
`Enter either Customer Number or complete the Correspondence Information section below.
`For further information see 37 CFR 1.33(a).
`
`[_] An Addressis being provided for the correspondenceInformation of this application.
`
`Customer Number
`
`Application Information:
`
`Email Address
`
`Title of the Invention
`
`STABLE, HIGHLY PURE L-CYSTEINE COMPOSITIONS FOR INJECTION AND METHODS OF USE
`
`[_]
`Attorney Docket Number] 066859/543317
`Small Entity Status Claimed
`Application Type
`Nonprovisional
`
`Total Number of Drawing Sheets (if any)
`
`
`
`Suggested Figure for Publication (if any)
`
`
`
`
`
`Filing By Reference:
`
`Only complete this section when filing an application by reference under 35 U.S.C. 111{c) and 37 CFR 1.57(a). Do not complete this section if
`application papers including a specification and any drawings are being filed. Any domestic benefit or foreign priority information must be
`provided in the appropriate section(s) below (i.e., “Domestic Benefit/National Stage Information” and “Foreign Priority Information’).
`
`For the purposes ofa filing date under 37 CFR 1.53(b), the description and any drawings of the present application are replaced by this
`reference to the previously filed application, subject to conditions and requirements of 37 CFR 1.57(a).
` i
`Application number of the previously
`Filing date (YYYY-MM-DD)
`Intellectual Property Authority or Country
`filed application
`
`
`
`
`
`Publication Information:
`
`[] Request Early Publication (Fee required at time of Request 37 CFR 1.219)
`Request Not to Publish. | hereby request that the attached application not be published under
`35 U.S.C. 122(b) and certify that the invention disclosed in the attached application has not and will not be the
`subject of an application filed in another country, or under a multilateral international agreement, that requires
`publication at eighteen months after filing.
`EFS Web 2.2.13
`
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`Eton Ex. 1107
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`

`PTO/AIA/14 (02-18)
`Approved for use through 11/30/2020. OMB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, na persons are required to respond to a collection of information unless it contains a valid OMB control number.
`
`. Attorney Docket Number|066859/543317.
`
`
`
`Application Data Sheet 37 CFR 1.76
`
`Application Number
`
`Title of Invention
`
`STABLE, HIGHLY PURE L-CYSTEINE COMPOSITIONS FOR INJECTION AND METHODS OF USE
`
`Representative Information:
`
`Representative information should be providedforall practitioners having a powerof attorney in the application. Providing
`this information in the Application Data Sheet does not constitute a power of attorney in the application (see 37 CFR 1.32).
`Either enter Customer Number or complete the Representative Name section below. If both sections are completed the customer
`Numberwill be used for the Representative Information during processing.
`
`
`
`Please Select One: ©) US PatentPractitioner|() Limited Recognition (37 CFR 11.9)Ce) Customer Number
`
`
`
`Customer Number
`00826
`
`Domestic Benefit/National Stage Information:
`
`This section allows for the applicant to either claim benefit under 35 U.S.C. 119(e), 120, 121, 365(c), or 386(c) or indicate
`National Stage entry from a PCT application. Providing benefit claim information in the Application Data Sheet constitutes
`the specific reference required by 35 U.S.C. 119(e) or 120, and 37 CFR 1.78.
`When referring to the current application, please leave the “Application Number’field blank.
`
`
`Prior Application Status|Pending
`Filing or 371(c) Date
`(YYYY-MM-DD)
`Prior Application Number
`Continuity Type
`Application Number
`
`Continuation of
`16746028
`2020-01-17
`
`Application Number
`
`
`
`
`
`
`
`
`
`
`
`
`Prior Application Status|Pending
`Filing or 371(c) Date
`(YYYY-MM-DD)
`
`Continuity Type
`
`Prior Application Number
`
`16746028
`
`Continuation of
`
`16/665702
`
`2019-10-28
`
`
`Prior Application Status|Patented
`Application
`_
`Prior Application
`Filing Date
`Issue Date
`Patent Number
`Number
`Continuity Type
`Number
`(YYYY-MM-DD)
`(YYYY-MM-DD)
`
`16/665702
`Continuation of
`16/248460
`2019-01-15
`10478453
`2019-11-19
`
`
`
`Additional Domestic Benefit/National Stage Data may be generated within this form
`by selecting the Add button.
`
`Foreign Priority Information:
`
`EFS Web 2.2.13
`
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`
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`

`

`PTO/AIA/14 (02-18)
`Approved for use through 11/30/2020. OMB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, na persons are required to respond to a collection of information unless it contains a valid OMB control number.
`
`
`. Attorney Docket Number|066859/543317.
`
`
`Application Data Sheet 37 CFR 1.76
`
`
`
`
`
`
`
`
`
`Application Number
`
`Title of Invention
`
`STABLE, HIGHLY PURE L-CYSTEINE COMPOSITIONS FOR INJECTION AND METHODS OF USE
`
`
`
`This section allows for the applicant to claim priority to a foreign application. Providing this information in the application data sheet
`constitutes the claim for priority as required by 35 U.S.C. 119(b) and 37 CFR 1.55. When priority is claimed to a foreign application
`thatis eligible for retrieval under the priority document exchange program (PDX) the information will be used by the Office to
`automatically attempt retrieval pursuant to 37 CFR 1.55(i)(1) and (2). Under the PDX program, applicant bears the ultimate
`responsibility for ensuring that a copy of the foreign application is received by the Office from the participating foreign intellectual
`property office, or a certified copy of the foreign priority applicationis filed, within the time period specified in 37 CFR 1.55(g)(1).
`
`Access Code(if applicable)
`
`Application Number
`
`Filing Date (YYYY-MM-DD)
`Country!
`
`
`Additional Foreign Priority Data may be generated within this form by selecting the
`Addbutton.
`
`Statement under 37 CFR 1.55 or 1.78 for AIA (First Inventor to File) Transition
`Applications
`
`
`
`This application (1) claims priority to or the benefit of an application filed before March 16, 2013 and (2) also
`contains, or contained at any time, a claim to a claimed invention that has an effectivefiling date on or after March
`[_] 16, 2013.
`NOTE: By providing this statement under 37 CFR 1.55 or 1.78, this application, with a filing date on or after March
`16, 2013, will be examined under the first inventorto file provisions of the AIA.
`
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`PTO/AIA/14 (02-18)
`Approved for use through 11/30/2020. OMB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, na persons are required to respond to a collection of information unless it contains a valid OMB control number.
`
`. Attorney Docket Number|066859/543317.
`
`
`
`Application Data Sheet 37 CFR 1.76
`
`Application Number
`
`Title of Invention
`
`STABLE, HIGHLY PURE L-CYSTEINE COMPOSITIONS FOR INJECTION AND METHODS OF USE
`
`
`
`
`Authorization or Opt-Out of Authorization to Permit Access:
`
`When this Application Data Sheet is properly signed andfiled with the application, applicant has provided written authority
`to permit a participating foreign intellectual property (IP) office access to the instant application-as-filed (see paragraph A
`in subsection 1 below) and the European Patent Office (EPO) access to any search results from the instant application
`(see paragraphBin subsection 1 below).
`
`
`
`
`
`Should applicant choose not to provide an authorization identified in subsection 1 below, applicant must opt-out of the
`authorization by checking the corresponding box A or B or both in subsection 2 below.
`
`
`
`
`NOTE: This section of the Application Data Sheet is ONLY reviewed and processed with the INITIALfiling of an
`application. After the initial filing of an application, an Application Data Sheet cannot be used to provide or rescind
`authorization for access by a foreign IP office(s).
`Instead, Form PTO/SB/39 or PTO/SB/69 must be used as appropriate.
`
`1. Authorization to Permit Access by a Foreign Intellectual Property Office(s)
`
`A. Priority Document Exchange (PDX) - Unless box A in subsection 2 (opt-out of authorization) is checked, the
`undersigned hereby grants the USPTO authority to provide the European Patent Office (EPO), the Japan Patent Office
`(JPO), the Korean Intellectual Property Office (KIPO), the State Intellectual Property Office of the People’s Republic of
`China (SIPO)}, the World Intellectual Property Organization (WIPO), and any other foreign intellectual property office
`participating with the USPTOin a bilateral or multilateral priority document exchange agreementin which a foreign
`application claiming priority to the instant patent application is filed, access to: (1) the instant patent application-as-filed
`and its related bibliographic data, (2) any foreign or domestic application to which priority or benefit is claimed by the
`instant application and its related bibliographic data, and (3) the date offiling of this Authorization. See 37 CFR 1.14(h)
`(1).
`
`B. Search Results from U.S. Application to EPO - Unless box B in subsection 2 (opt-out of authorization) is checked,
`the undersigned hereby grants the USPTO authority to provide the EPO accessto the bibliographic data and search
`results from the instant patent application when a European patent application claiming priority to the instant patent
`application is filed. See 37 CFR 1.14(h)(2).
`
`The applicant is reminded that the EPO’s Rule 141(1) EPC (European Patent Convention) requires applicants to submit a
`copy of search results from the instant application without delay in a European patent application that claimspriority to
`the instant application.
`
`2. Opt-Out of Authorizations to Permit Access by a Foreign Intellectual Property Office(s)
`
`[|]
`
`A. Applicant DOES NOT authorize the USPTOto permit a participating foreign IP office access to the instant
`application-as-filed.
`If this box is checked, the USPTOwill not be providing a participating foreign IP office with
`any documents and information identified in subsection 1A above.
`
`[_]
`
`B. Applicant DOES NOTauthorize the USPTO to transmit to the EPO any search results from the instant patent
`application. If this box is checked, the USPTO will not be providing the EPO with search results from the instant
`application.
`NOTE: Once the application has published or is otherwise publicly available, the USPTO may provide accessto the
`application in accordance with 37 CFR 1.14.
`
`EFS Web 2.2.13
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`

`PTO/AIA/14 (02-18)
`Approved for use through 11/30/2020. OMB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, na persons are required to respond to a collection of information unless it contains a valid OMB control number.
`
`. Attorney Docket Number|066859/543317.
`
`
`Application Data Sheet 37 CFR 1.76
`
`Application Number
`
`Title of Invention
`
`STABLE, HIGHLY PURE L-CYSTEINE COMPOSITIONS FOR INJECTION AND METHODS OF USE
`
`
`
`
`Applicant Information:
`
`Providing assignment information in this section does not substitute for compliance with any requirementof part 3 of Title 37 of CFR
`to have an assignment recorded by the Office.
`
`1
`Applicant
`If the applicant is the inventor (or the remaining joint inventor or inventors under 37 CFR 1.45), this section should not be completed.
`The information to be provided in this section is the name and addressofthe legal representative whois the applicant under 37 CFR
`1.43; or the name and address of the assignee, person to whom the inventoris under an obligation to assign the invention, or person
`whootherwise showssufficient proprietary interest in the matter whois the applicant under 37 CFR 1.46. If the applicant is an
`applicant under 37 CFR 1.46 (assignee, person to whom theinventor is obligated to assign, or person who otherwise showssufficient
`proprietary interest) together with one or more joint inventors, then the joint inventor or inventors who are also the applicant should be
`identified in this section.
`
`
`
`(@) Assignee
`oO Legal Representative under 35 U.S.C. 117
`CQ Joint Inventor
`
`
`O Person to whomtheinventoris obligated to assign.
`
`oO
`
`Person who showssufficient proprietary interest
`
`If applicant is the legal representative, indicate the authority to file the patent application, the inventoris:
`
`
`
`
`Nameof the Deceased or Legally Incapacitated Inventor:Po
`
`If the Applicant is an Organization check here.
`[x]
`Organization Name
`Exela Pharma Sciences, LLC
`
`
`
`
`
`Address1
`Address 2
`
`
`Mailing Address Information For Applicant:
`
`
`1245 Blowing Rock Blvd
`
`
`
`Fax Number
`
`Email Address
`
`Additional Applicant Data may be generated within this form by selecting the Add button.
`
`
`
`City NC Lenoir State/Province
`
`
`
`
`US
`Postal Code
`28645
`Country’
`
`Phone Number
`
`
`
`Assignee Information including Non-Applicant Assignee Information:
`
`Providing assignment information in this section does not substitute for compliance with any requirement of part 3 of Title
`
`37 of CFR to have an assignmentrecorded by the Office.
`
`EFS Web 2.2.13
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`PTO/AIA/14 (02-18)
`Approved for use through 11/30/2020. OMB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, na persons are required to respond to a collection of information unless it contains a valid OMB control number.
`
`
`Attorney Docket Number|066859/543317 Application Data Sheet 37 CFR 1.76
`
`Application Number
`
`Title of Invention
`STABLE, HIGHLY PURE L-CYSTEINE COMPOSITIONS FOR INJECTION AND METHODS OF USE
`
`
`
`1
`Assignee
`
`Complete this section if assignee information, including non-applicant assigneeinformation, is desired to be included on the patent
`application publication. An assignee-applicant identified in the “Applicant Information" section will appear on the patent application
`publication as an applicant. For an assignee-applicant, complete this section onlyif identification as an assignee is also desired on the
`patent application publication.
`
`
`If the Assignee or Non-Applicant Assignee is an Organization check here.
` Given Name
`Middle Name
`
`[|
`
`Family Name
`
`Suffix
`
` Prefix
`
`Mailing Address Information For Assignee including