<SEC-DOCUMENT>0001193125-25-001480.txt : 20250210
<SEC-HEADER>0001193125-25-001480.hdr.sgml : 20250210
<ACCEPTANCE-DATETIME>20250103160010
<PRIVATE-TO-PUBLIC>
ACCESSION NUMBER:		0001193125-25-001480
CONFORMED SUBMISSION TYPE:	CORRESP
PUBLIC DOCUMENT COUNT:		1
FILED AS OF DATE:		20250103

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			MACROGENICS INC
		CENTRAL INDEX KEY:			0001125345
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		ORGANIZATION NAME:           	03 Life Sciences
		IRS NUMBER:				000000000
		STATE OF INCORPORATION:			DE
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		CORRESP

	BUSINESS ADDRESS:	
		STREET 1:		9704 MEDICAL CENTER DRIVE
		CITY:			Rockville
		STATE:			MD
		ZIP:			20850
		BUSINESS PHONE:		301-251-5172

	MAIL ADDRESS:	
		STREET 1:		9704 MEDICAL CENTER DRIVE
		CITY:			ROCKVILLE
		STATE:			MD
		ZIP:			20850
</SEC-HEADER>
<DOCUMENT>
<TYPE>CORRESP
<SEQUENCE>1
<FILENAME>filename1.htm
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<TITLE>CORRESP</TITLE>
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<Center><DIV STYLE="width:8.5in" align="left">
 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="right">MacroGenics, Inc.<B> </B> </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="right">9704 Medical Center Drive </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="right">Rockville,
Maryland 20850 </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="justify">January&nbsp;3, 2025 </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B><U>VIA EDGAR </U></B></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="justify">U.S. Securities and
Exchange Commission </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="justify">Division of Corporation Finance </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="justify">Office of Life Sciences 100 F Street, N.E. </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="justify">Washington, D.C. 20549 </P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="4%" VALIGN="top" ALIGN="left">Attn:</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="justify">Daniel Gordon </P></TD></TR></TABLE>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman" ALIGN="justify">Bonnie Baynes </P> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TR style = "page-break-inside:avoid">
<TD WIDTH="4%" VALIGN="top" ALIGN="left">Re:</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="justify"><B>MacroGenics</B><B>, Inc. (the </B><B>&#147;</B><B><I>Company</I></B><B>&#148;</B><B>)</B>
</P></TD></TR></TABLE> <P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman" ALIGN="justify"><B></B><B>Form <FONT STYLE="white-space:nowrap">10-K</FONT> </B><B>for the Fiscal Year Ended
December</B><B></B><B>&nbsp;31, 2023</B> </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman" ALIGN="justify"><B></B><B>Form <FONT STYLE="white-space:nowrap">10-Q</FONT> for the Quarterly
Period Ended September</B><B></B><B>&nbsp;30, 2024</B> </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman" ALIGN="justify"><B></B><B>File
No.</B><B></B><B><FONT STYLE="white-space:nowrap">&nbsp;001-36112</FONT></B> </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="justify">Ladies and Gentlemen: </P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman" ALIGN="justify">This letter sets forth the Company&#146;s responses (the &#147;<B><I>Response Letter</I></B>&#148;) to the comments of the
staff (the &#147;<B><I>Staff</I></B>&#148;) of the Securities and Exchange Commission contained in the letter dated December&nbsp;3, 2024 (the &#147;<B><I>Comment Letter</I></B>&#148;), relating to the above referenced Form <FONT
STYLE="white-space:nowrap">10-K</FONT> for the fiscal year ended December&nbsp;31, 2023 (the &#147;<B><I>Form <FONT STYLE="white-space:nowrap">10-K</FONT></I></B>&#148;) and Form <FONT STYLE="white-space:nowrap">10-Q</FONT> for the quarterly period
ended September&nbsp;30, 2024 (the &#147;<B><I>Form <FONT STYLE="white-space:nowrap">10-Q</FONT></I></B>&#148;). The Staff&#146;s comments included in the Comment Letter are repeated below in bold and are followed by the Company&#146;s responses.
Capitalized terms used but not defined herein are used herein as defined in the Form <FONT STYLE="white-space:nowrap">10-K</FONT> and Form <FONT STYLE="white-space:nowrap">10-Q.</FONT> </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B><U>Form <FONT STYLE="white-space:nowrap">10-Q</FONT> for the Quarterly Period Ended September&nbsp;30, 2024 </U></B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B><U>Notes to Consolidated Financial Statements </U></B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B><U>Note 9. Commitments and Contingencies </U></B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B><U>Securities Litigation, page 15 </U></B></P> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="4%" VALIGN="top" ALIGN="left"><B>1.</B></TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="justify"><B>We note your disclosures in Item 1 on page 23 that you are or may be involved in various legal
proceedings, your disclosure on page 15 of the putative securities class action suit filed against you on July&nbsp;26, 2024, and that &#147;no reserve has been established for any potential liability related to this suit.&#148; To the extent it is
reasonably possible that you will incur losses in excess of recorded accruals related to your contingencies, please provide in future filings the applicable disclosures required by ASC
<FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">450-20-50-3</FONT></FONT></FONT> through <FONT STYLE="white-space:nowrap">50-4,</FONT> including the amount or range of reasonably possible losses in
excess of recorded amounts. If an estimate of reasonably possible additional losses can be made and that amount is not material to your consolidated financial position, results of operations or cash flows, we will not object to a statement to that
effect. Alternatively, if no amount of loss in excess of recorded accruals is believed to be reasonably possible, please state this in your disclosure. Although we recognize that there are a number of uncertainties and potential outcomes associated
with loss contingencies, please note that ASC 450 does not require estimation of a reasonably possible range of loss with precision or certainty. </B></P></TD></TR></TABLE>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="justify">January 3, 2025 </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="justify"> Page
 2
 </P> <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P>
 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="justify"><U>Company Response</U>: </P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman" ALIGN="justify">The Company acknowledges the Staff&#146;s comment and respectfully advises the Staff that it regularly evaluates the status of
all legal proceedings in which the Company is involved to assess whether accruals for probable losses are appropriate under ASC <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">450-20-50</FONT></FONT> and to determine for disclosure
purposes whether an estimate of possible loss or range of loss can be made under ASC <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">450-20-50.</FONT></FONT> </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman" ALIGN="justify">During these evaluations, the Company&#146;s management considers all existing and new matters, to the extent any exist,
including, but not limited to, (i)&nbsp;the nature of the legal proceeding; (ii)&nbsp;the status of each proceeding; (iii)&nbsp;the advice of legal counsel and other advisors related to each proceeding; (iv)&nbsp;the Company&#146;s experience or
that of other entities in similar proceedings; (v)&nbsp;the Company&#146;s belief in whether it has meritorious and valid substantive defenses against the allegations made by the parties in the proceedings; (vi)&nbsp;the damages sought for each
proceeding; (vii)&nbsp;substantive rulings by a court on similar proceedings; (viii)&nbsp;information gleaned through settlement discussions, if any; (ix)&nbsp;whether there is uncertainty as to the outcome of pending appeals or motions;
(x)&nbsp;whether there are significant factual issues to be resolved; and/or (xi)&nbsp;whether the matters involve novel issues or unsettled legal theories. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman" ALIGN="justify">At the time of the filing of the Form <FONT STYLE="white-space:nowrap">10-Q,</FONT> the Company evaluated potential loss
contingencies as discussed above and Company did not determine that a loss was reasonably possible, given the early stage of the proceedings. Subsequently, the securities class action lawsuit referenced in the Staff&#146;s comment no. 1 has been
dismissed.<SUP STYLE="font-size:75%; vertical-align:top">1</SUP> As of the date of this Response Letter,<B> </B>we continue to believe no additional disclosure<B> </B>pursuant to ASC <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap"><FONT
STYLE="white-space:nowrap">450-20-50-3</FONT></FONT></FONT> through <FONT STYLE="white-space:nowrap">50-4</FONT> is warranted or required related to the putative securities class action lawsuit. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman" ALIGN="justify">We will continue to monitor and evaluate the status of legal proceedings, if any, each quarter based on the factors described
above to determine the need for disclosure. If at a future time there is at least a reasonable possibility that a material loss may be incurred with respect to a particular legal proceeding, we would either (i)&nbsp;disclose an estimate of the loss
or range of loss (or, if applicable, state that the estimate is immaterial in lieu of providing quantified amounts) or (ii)&nbsp;state that such an estimate cannot be made. In addition, in future filings, if no amount of loss in excess of any
recorded accruals is believed to be reasonably possible, we will so state this in our disclosure.<B> </B> </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B><U>Item&#8201;2. Management&#146;s
Discussion and Analysis of Financial Condition and Results of Operations, page 17 </U></B></P> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="4%" VALIGN="top" ALIGN="left"><B>2.</B></TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="justify"><B>We note your disclosure on page 17 that your expected funding requirements reflect anticipated
expenditures related to the ongoing Phase 2 TAMARACK clinical trial of vobramitamab duocarmazine (vobra duo, an antibody-drug conjugate or ADC), your May&nbsp;9, 2024 press release and slide 14 of your related investor presentation disclose five
TEAEs with fatal outcomes during your TAMARACK Phase 2 study of vobramitamab duocarmazine (vobra duo), your July&nbsp;30, 2024 press release discloses the discontinuation of that study, the July&nbsp;26, 2024 putative securities class action lawsuit
filed against you regarding that Phase 2 study disclosed on pages 11 and 15 of your June&nbsp;30, 2024 and September&nbsp;30, 2024 forms <FONT STYLE="white-space:nowrap">10-Q</FONT> filed August&nbsp;6, 2024 and November&nbsp;5, 2024, respectively,
and your November&nbsp;5, 2024 press release disclosure that you are delaying further development of the ADC vobra duo until you receive mature progression free survival data in early 2025. We further note the significant drop in your stock price
and volume </B></P></TD></TR></TABLE> <P STYLE="line-height:8.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #000000;width:11%">&nbsp;</P>
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<TR style = "page-break-inside:avoid">
<TD WIDTH="4%" VALIGN="top" ALIGN="left"><SUP STYLE="font-size:75%; vertical-align:top">1</SUP>&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="justify">On December&nbsp;16, 2024, the plaintiffs in the referenced lawsuit filed a Notice of Voluntary Dismissal
with the U.S. District Court for the District of Maryland. On December&nbsp;20, 2024, the Court filed an acknowledgement of the dismissal. As of the date of this Response Letter, state shareholder derivative suits filed in December 2024 related to
the class action suit remain outstanding. </P></TD></TR></TABLE>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="justify">January 3, 2025 </P>
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<TD ALIGN="left" VALIGN="top"> <P ALIGN="justify" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Times New Roman; font-size:10pt"><B>
traded on May&nbsp;10, 2024 to $3.31 per share and 35,138,360 shares from $14.67 per share and 4,882,225 shares on May&nbsp;9, 2024. Please provide the following: </B></P></TD></TR></TABLE>
<P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="3%" VALIGN="top" ALIGN="left"><B>&#149;</B></TD>
<TD WIDTH="1%" VALIGN="top">&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"> <P ALIGN="justify" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Times New Roman; font-size:10pt"><B>We note your disclosure in your November&nbsp;5, 2024 press release that: &#147;The TAMARACK Phase 2 study
of vobra duo is being conducted in patients with metastatic castration-resistant prostate cancer (mCRPC). While study participants are no longer being dosed in the study, participants continue to be monitored for adverse events, disease progression
and survival.&#148; Given the five patient deaths in the Phase 2 TAMARACK study, discontinuation of that study, and your ability to estimate the study&#146;s future funding needs, please tell us and provide proposed disclosure for future filings of
the significant trends in terms of safety risk related to vobra duo, and specifically how these patient deaths relating to vobra duo impact your continued development of this product candidate. </B></P></TD></TR></TABLE>
<P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="5%">&nbsp;</TD>
<TD WIDTH="3%" VALIGN="top" ALIGN="left"><B>&#149;</B></TD>
<TD WIDTH="1%" VALIGN="top">&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"> <P ALIGN="justify" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Times New Roman; font-size:10pt"><B>We note your disclosure in your November&nbsp;5, 2024 press release of: &#147;Assessment of future
development alternatives for vobra duo will be based on several factors, including the final TAMARACK safety...&#148; and &#147;the Company has paused its other development efforts in alternative tumor types as well as the Phase 1/2 dose combination
study of vobra duo plus lorigerlimab.&#148; Please provide proposed disclosure for future filings of risk factor disclosure relating to the above serious adverse events, including the period(s) that the patient deaths occurred, and all other serious
adverse events related to your products, and potential risks to the company from those events. </B></P></TD></TR></TABLE>
<P STYLE="margin-top:6pt; margin-bottom:0pt; margin-left:4%; text-indent:4%; font-size:10pt; font-family:Times New Roman" ALIGN="justify">The Company acknowledges the Staff&#146;s comments and advises the Staff the following, with respect to each of
the bullet points above: </P> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="10%">&nbsp;</TD>
<TD WIDTH="2%" VALIGN="top" ALIGN="left">&#149;</TD>
<TD WIDTH="1%" VALIGN="top">&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"> <P ALIGN="justify" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Times New Roman; font-size:10pt"><B>Safety trends of </B><B>vobra</B><B> duo:</B> The Company has, and will continue to, carefully evaluate the
safety of vobra duo over the course of the TAMARACK study (the &#147;<B><I>Study</I></B>&#148;) in consultation with the investigators of the Study and the Independent Data Monitoring Committee (the &#147;<B><I>IDMC</I></B>&#148;). The Company has
reported, and continues to report, investigator-reported treatment-related serious adverse events on the Study, including fatalities,<SUP STYLE="font-size:75%; vertical-align:top">2</SUP> to the Food and Drug Administration (the
&#147;<B><I>FDA</I></B>&#148;) in accordance with our regulatory obligations. As the Company previously reported in late&nbsp;July 2024, after a review of accumulated Study data though a July&nbsp;9, 2024 data cut-off,&nbsp;at which time there were
an aggregate of eight investigator-reported, treatment-related deaths on the Study, MacroGenics&nbsp;agreed with the IDMC recommendation that Study treatment should be discontinued for the remaining mCRPC Study participants who potentially could
have received additional doses. At that point in time, there were a limited number of mCRPC patients still potentially eligible to receive additional doses of vobra duo and the Study had reached the primary endpoint. Although treatment was
discontinued for mCRPC patients, the mCPRC patients remaining on the Study continued to be monitored per Study protocol. As of December&nbsp;16, 2024, the investigators for the Study for all indications have reported an aggregate of eleven
treatment-related deaths (11 of 180 patients, or 6.1%). These eleven patient deaths occurred between 87 days and 339 days after commencing treatment with vobra duo. Patients who remain on the Study no longer receive treatment, but continue to be
monitored for adverse events, disease progression and survival, and adverse events continue to be reported to the FDA as and when required. </P></TD></TR></TABLE> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<P STYLE="line-height:8.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #000000;width:11%">&nbsp;</P>
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<TD WIDTH="4%" VALIGN="top" ALIGN="left"><SUP STYLE="font-size:75%; vertical-align:top">2</SUP>&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="justify">An investigator-reported, treatment-related fatality is one which the reporting investigator believed at the
time of the report to have been the result of a serious adverse event the investigator believed at the time of the report to be at least possibly treatment related. </P></TD></TR></TABLE>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="justify">January 3, 2025 </P>
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<TD ALIGN="left" VALIGN="top"> <P ALIGN="justify" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Times New Roman; font-size:10pt"><B>Impact of safety on continued development of vobra duo:</B> No patients are currently being treated with
vobra duo in a Company-sponsored trial, although an investigator-sponsored study is continuing as of the date of this Response Letter. Study patients are being followed per Study protocol for an evaluation of mature efficacy data, including median
radiographic progression-free survival. The Company is considering whether to explore in an additional safety study, should mature efficacy data warrant, whether certain adverse events potentially associated with prolonged exposure to vobra duo
could be mitigated by various strategies. As of the date of this Response Letter, no decision has been made regarding such a study or studies, nor the funding of future vobra duo development. A decision by the Company regarding whether and how to
continue development of vobra duo in additional safety studies will be made only after careful evaluation of safety risks weighed against the potential clinical benefit, as well as MacroGenics&#146; financing or partnering opportunities and
engagement with the FDA. In particular, while we or investigators may explore methods to mitigate adverse events potentially associated with vobra duo treatment in a future Phase 2 study or studies, we do not expect to commence a registrational
Phase 3 study until or unless such additional study or studies (if any) inform an appropriate risk/benefit assessment of the program development, and assuming there are clinical, financial and competitive rationale to pursue such a registration
study. </P></TD></TR></TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman" ALIGN="justify">As the Staff requested, in Exhibit A attached hereto, we have included proposed disclosure
related to (i)&nbsp;the significant trends in terms of safety risk related to vobra duo, and specifically how these patient deaths relating to vobra duo impact our continued development of this product candidate and (ii)&nbsp;risk factor disclosure
relating to the above serious adverse events, including the period(s) that the patient deaths occurred, and all other serious adverse events related to our products, and potential risks to us from those events. </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B><U>Item&#8201;4. Controls and Procedures </U></B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B><U>Disclosure Controls and Procedures, page 22 </U></B></P> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="justify"><B>We note that your 906 certifications filed as exhibits 32 in your quarterly forms <FONT
STYLE="white-space:nowrap">10-Q</FONT> only include reference to your compliance with the requirements of Section&nbsp;13(a) of the Securities Exchange Act of 1934, as amended, whereas your exhibits 32 in your annual forms <FONT
STYLE="white-space:nowrap">10-K</FONT> appropriately include reference to your compliance with the requirements of Section&nbsp;13(a) and 15(d) of the Securities Exchange Act of 1934, as amended. Please revise your 906 certifications in future <FONT
STYLE="white-space:nowrap">10-Q</FONT> filings to consistently disclose your compliance as you have done in your form <FONT STYLE="white-space:nowrap">10-Ks.</FONT> </B></P></TD></TR></TABLE>
<P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman" ALIGN="justify">The Company respectfully acknowledges the Staff&#146;s comment and advises the Staff that the disclosure to which this comment
relates will be included in the Company&#146;s 906 certifications in future filings. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center">*&#8195;&#8195;*&#8195;&#8195;* </P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman" ALIGN="justify">If you have any questions regarding the response letter or require
additional information, please contact Eric Blanchard of Cooley LLP at (212) <FONT STYLE="white-space:nowrap">479-6565</FONT> or eblanchard@cooley.com, or Reid Hooper of Cooley LLP at (202) <FONT STYLE="white-space:nowrap">776-2097</FONT> or
rhooper@cooley.com. </P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><DIV ALIGN="right">
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<TD VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; margin-left:1.00em; text-indent:-1.00em; font-size:10pt; font-family:Times New Roman">Very truly yours,</P></TD></TR>
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<TD VALIGN="top" STYLE="BORDER-BOTTOM:1px solid #000000"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; margin-left:1.00em; text-indent:-1.00em; font-size:10pt; font-family:Times New Roman">/s/ James Karrels</P></TD></TR>
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<TD VALIGN="top"> <P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:1.00em; text-indent:-1.00em; font-size:10pt; font-family:Times New Roman">James Karrels</P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; margin-left:1.00em; text-indent:-1.00em; font-size:10pt; font-family:Times New Roman">Senior Vice President and Chief Financial Officer</P></TD></TR>
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<TD VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; margin-left:1.00em; text-indent:-1.00em; font-size:10pt; font-family:Times New Roman">MacroGenics, Inc.</P></TD></TR>
</TABLE></DIV> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="4%" VALIGN="top" ALIGN="left">cc:</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="justify">Scott Koenig, M.D., Ph.D., President and Chief Executive Officer and Director, MacroGenics, Inc.
</P></TD></TR></TABLE> <P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman" ALIGN="justify">Jeffrey Peters, Senior Vice President and General Counsel, MacroGenics, Inc. </P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="justify">January 3, 2025 </P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>Exhibit A </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; margin-left:9%; font-size:10pt; font-family:Times New Roman" ALIGN="justify">The Company respectfully submits the following proposed disclosure regarding the Staff&#146;s comment No.&nbsp;2 included in
the Comment Letter, which will be included in future filings. We intend to update these disclosures in said future filings as further information becomes available. </P> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="1%" VALIGN="top">&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"> <P ALIGN="justify" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Times New Roman; font-size:10pt"><B>We note your disclosure in your November&nbsp;5, 2024 press release that: &#147;The TAMARACK Phase 2 study
of vobra duo is being conducted in patients with metastatic castration-resistant prostate cancer (mCRPC). While study participants are no longer being dosed in the study, participants continue to be monitored for adverse events, disease progression
and survival.&#148; Given the five patient deaths in the Phase 2 TAMARACK study, discontinuation of that study, and your ability to estimate the study&#146;s future funding needs, please tell us and provide proposed disclosure for future filings of
the significant trends in terms of safety risk related to vobra duo, and specifically how these patient deaths relating to vobra duo impact your continued development of this product candidate. </B></P></TD></TR></TABLE>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Annual Report on Form <FONT STYLE="white-space:nowrap">10-K</FONT> </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Business </B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>. . . </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Our Pipeline of Oncology Product Candidates for Which We Retain Commercial Rights </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>. . . </B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B><FONT STYLE="white-space:nowrap">B7-H3</FONT>
Programs </B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B><I>Vobramitamab Duocarmazine </I></B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="justify">Vobra duo (previously known as MGC018) is an investigational ADC with a cleavable peptide linker designed to deliver a <FONT
STYLE="white-space:nowrap">DNA-alkylating</FONT> duocarmycin payload to dividing and <FONT STYLE="white-space:nowrap">non-dividing</FONT> cells on solid tumors that express <FONT STYLE="white-space:nowrap">B7-H3.</FONT> The underlying ADC technology
was licensed from Byondis B.V. (Byondis). We initiated the TAMARACK Phase 2 study in late 2022. The TAMARACK protocol was amended in 2023 to remove a comparator arm. The TAMARACK study was designed to evaluate 100 patients across two experimental
arms in which participants receive vobra duo at either 2.0 mg/kg or 2.7 mg/kg once every four weeks (Q4W). We completed enrollment of Part 1 (consisting of mCRPC patients only) of the Study in the fourth quarter of 2023, having enrolled a total of
181 patients, exceeding the targeted number of patients. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="justify">In late&nbsp;July 2024, after a review of accumulated study data though a
July&nbsp;9, 2024 data <FONT STYLE="white-space:nowrap">cut-off,&nbsp;at</FONT> which time there were an aggregate of eight investigator-reported, treatment-related deaths on Part 1 of the TAMARACK study, MacroGenics&nbsp;agreed with the TAMARACK
study&#146;s Independent Data Monitoring Committee (IDMC) recommendation that study treatment should be discontinued for the remaining mCRPC Study participants who potentially could have received additional doses. Although treatment with vobra duo
was discontinued for these patients, the TAMARACK study continued, as mCRPC patients continued to be monitored per study protocol. Any mCRPC patients who remained on the Study did not receive treatment but continued to be monitored for adverse
events, disease progression and survival; in addition, adverse events continued to be reported to the FDA as and when required. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="justify">The
Company is considering exploring in an additional safety study, should mature efficacy data warrant, whether adverse events potentially associated with prolonged exposure to vobra duo could be mitigated by various strategies. Any decision to
continue development of vobra duo will be made only after careful evaluation of safety risks weighed against the potential clinical benefit, as well as a review </P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="justify">January 3, 2025 </P>
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of the competitive treatment landscape for mCRPC and other potential indications, resource allocation across the Company&#146;s clinical portfolio and potential partnering opportunities for vobra
duo. In particular, while we may explore methods to mitigate adverse events potentially associated with vobra duo treatment in a future Phase 2 study or studies, we do not expect to commence a registrational Phase 3 study until or unless such
additional study or studies (if any) inform an appropriate risk/benefit assessment of the program development, and assuming there are clinical, financial and competitive rationale to pursue such a registration study. </P>
<P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD ALIGN="left" VALIGN="top"> <P ALIGN="justify" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Times New Roman; font-size:10pt"><B>We note your disclosure in your November&nbsp;5, 2024 press release of: &#147;Assessment of future
development alternatives for vobra duo will be based on several factors, including the final TAMARACK safety...&#148; and &#147;the Company has paused its other development efforts in alternative tumor types as well as the Phase 1/2 dose combination
study of vobra duo plus lorigerlimab.&#148; Please provide proposed disclosure for future filings of risk factor disclosure relating to the above serious adverse events, including the period(s) that the patient deaths occurred, and all other serious
adverse events related to your products, and potential risks to the company from those events.</B> </P></TD></TR></TABLE> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B><I>Our product candidates have
had and may in the future have serious side effects, including fatalities. These side effects may delay or prevent further clinical development or marketing approval, or, if approval is received, require them to be taken off the market, require them
to include safety warnings or otherwise limit their sales. </I></B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="justify">Although all of our product candidates have undergone or will undergo
safety testing, not all adverse effects of drugs can be predicted or anticipated. Unforeseen side effects from any of our product candidates have arisen, either during clinical development or after the approved product has been marketed, and may
arise in the future. Ongoing or future trials of our product candidates may not support the conclusion that one or more of these product candidates have acceptable safety profiles. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="justify">The results of future clinical or nonclinical trials may show undesirable or unacceptable side effects, which could interrupt, delay or halt
clinical trials, and result in delay of, or failure to obtain, marketing approval from the FDA and other regulatory authorities, or result in marketing approval from the FDA and other regulatory authorities with restrictive label warnings, risk
management measures, or potential product liability claims. These risks have affected our business and may continue to do so. For example, in July 2022, we announced the discontinuation of our Phase 2 trial of enoblituzumab in combination with
either retifanlimab or tebotelimab in the treatment of patients with recurrent or metastatic SCCHN, based on an internal review of safety data. In addition, in July 2024, we announced the discontinuation of vobra duo treatment of mCRPC patients in
our TAMARACK study based on the recommendation of the study&#146;s Independent Data Monitoring Committee (IDMC). As of December&nbsp;16, 2024, the investigators for the TAMARACK study have reported a total of 11 treatment-related deaths across all
patient types (6.1% of the 180 patients who received treatment). These patient deaths occurred between 87 days and 339 days after commencing treatment with vobra duo. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="justify">Even if our products are approved for marketing, and we or others later identify undesirable or unacceptable side effects potentially caused
by such products: </P> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD ALIGN="left" VALIGN="top"> <P ALIGN="justify" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Times New Roman; font-size:10pt">regulatory authorities may require us to take our approved product off the market; </P></TD></TR></TABLE>
<P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD ALIGN="left" VALIGN="top"> <P ALIGN="justify" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Times New Roman; font-size:10pt">regulatory authorities may require the addition of labeling statements, specific warnings, a contraindication
or field alerts to physicians and pharmacies; </P></TD></TR></TABLE>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="justify">January 3, 2025 </P>
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<TD ALIGN="left" VALIGN="top"> <P ALIGN="justify" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Times New Roman; font-size:10pt">we may be required to change the way the product is administered, impose other risk-management measures,
conduct additional clinical trials or change the labeling of the product; </P></TD></TR></TABLE> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD ALIGN="left" VALIGN="top"> <P ALIGN="justify" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Times New Roman; font-size:10pt">we may be subject to limitations on how we may promote the product; </P></TD></TR></TABLE>
<P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD ALIGN="left" VALIGN="top"> <P ALIGN="justify" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Times New Roman; font-size:10pt">sales of the product may decrease significantly; </P></TD></TR></TABLE>
<P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD ALIGN="left" VALIGN="top"> <P ALIGN="justify" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Times New Roman; font-size:10pt">we may be subject to litigation or product liability claims; and </P></TD></TR></TABLE>
<P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD ALIGN="left" VALIGN="top"> <P ALIGN="justify" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Times New Roman; font-size:10pt">our reputation may suffer. </P></TD></TR></TABLE>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="justify">Any of these events could prevent us, our collaborators or our potential future partners from achieving or maintaining market acceptance of
the affected product or could substantially increase commercialization costs and expenses, which in turn could delay or prevent us from generating significant revenue from the sale of our products. </P>
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